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Category Archives: Clinical Trials

Podcast Recap: How Clinical Trials Work in the United States

 

 

 

 

 

 

 

 

 

 

 

 

 

In a recent B Heppy episode on clinical trials, Dr. Yasmin Ibrahim, Public Health Program Director at the Hepatitis B Foundation, discussed the process of how clinical trials work and the importance of clinical research in moving forward public health programs and interventions. 

What is a Clinical Trial? 

A clinical trial (also called clinical research) is the process for approving new medications or devices for a known health condition or disease. When people hear the term clinical trial, they may hink immediately that participants of that trial are at risk. What most don’t know is that before a medication or medical device is tested on human beings, it must go through a very rigorous process with approval from regulatory authorities and agencies. This is why clinical trials go through phases of approval and safety checks in the research process. We have outlined the phases of clinical trials below to help provide an understanding of the process.  

Pre-clinical or lab studies: Before the drug can be tested on human beings, it is thoroughly researched on living cells and then animals with similar biological makeup, to assess its efficacy (benefits) and safety. 

Clinical Phase I: Researchers test a new drug or treatment on a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify any side effects. 

Clinical Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. 

Clinical Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. 

Clinical Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in many different populations and determine any side effects associated with long-term use of the product or drug. 

All new treatments must go through clinical trials before being approved for use by the United States Food and Drug Administration (FDA), European Medicine Agency (EMA) or any other local regulatory authorities depending on the country.   

Advancing and Sustaining Public Health through Research 

Clinical trials are important because they are the safest way to develop and discover new treatments that work to cure diseases or improve the health and quality of life of patients. Because clinical trials have very strict safety regulations, they also tell us if a treatment is safe for people to use.  

Eligibility Criteria for Participation in Clinical Trials  

Eligibility criteria for clinical trials depends on the type of research being conducted. If a vaccine is being tested, then most participants are healthy to assess the response of the vaccine on the body’s immune system and the ability to produce protective antibodies. In some clinical trials that focus on certain populations or multiple conditions, the criteria may be more specific (e.g., testing the HBV treatments on people living with hepatitis B and diabetes). Study design and objectives determine participant eligibility and criteria. 

Diversity and Inclusivity in Clinical Trials 

Historically, clinical trials have neglected participation from minority populations and under-served communities. For example, sub-Saharan Africa has one of the highest burdens of hepatitis B globally, but clinical trials for hepatitis B are inadequate in those areas. The people who need access to clinical research the most are often denied access to these opportunities due to geographical barriers, lack of political will, regulatory issues, and other logistical challenges. It is important to ensure that all people who are directly impacted by hepatitis B should have access to participating in clinical trials and affording innovative therapies to improve their quality of life. There are steps that pharmaceutical and biotech companies, medical researchers, and public health organizations can take to diversify participation in clinical research. This involves including local patient-centered organizations and patient advocates in the clinical trial participation recruiting process. Partnering with a community is a helpful strategy to build trust with the community and engage people in research. Communication is integral to ensuring that participants fully understand the extent of their participation and the goals behind the research. Participants are encouraged to ask questions from the recruiters before agreeing to participate in the research.  

Find Clinical Trials for Hepatitis B here: https://www.hepb.org/treatment-and-management/clinical-trials/ 

Questions to Ask Providers and Researchers about Clinical Trial Participation: https://www.hepb.org/treatment-and-management/clinical-trials/ask-a-doctor/ 

To listen to the full episode on our podcast, B Heppy, click here. https://bheppy.buzzsprout.com/1729790/13443280 

 

Drug Profile: Three Hepatitis Delta Therapies That We Hope to See Widely Available Soon

 

 

 

 

The full extent of hepatitis delta’s (HDV) global disease burden is still unknown and treatment options for HDV have been limited. However, there are three promising up-and-coming drugs to treat HDV patients. This blog post details the drugs’ current phase of development and testing, how well they work for patients in the real world, and their current path toward regulation and market availability. 

Bulevirtide (Hepcludex) 

Gilead Sciences Inc. has been seeking approval from the U.S. Food and Drug Administration (FDA) for bulevirtide, or Hepcludex, since 2021. In 2020, Gilead acquired MYR, a German pharmaceutical company that had developed the hepatitis delta virus (HDV) drug. At the time that it was acquired, Hepcludex had already been conditionally authorized for use in Germany, France, and Austria (MYR Pharmaceuticals, 2020). Gilead, which is based in California, in the U.S., hoped to accelerate the global launch of Hepcludex. Since then, however, Hepcludex remains in regulatory limbo. In October 2022, the FDA announced the rejection of Hepcludex, citing concerns around the manufacturing and delivery of the drug. Gilead responded by stating that they plan to resubmit Hepcludex for approval as soon as possible (Dunleavy, 2022). Six months after the FDA rejection, the Committee for Medicinal Products for Human Use, which is the European Medicines Agency’s (EMA’s) committee responsible for conveying its opinions on medicinal products to the public, stated that it recommends Hepcludex for full marketing authorization in Europe. Since its conditional approval, a Phase 3 trial (which utilized data from patients in Germany, Italy, Russia, Sweden, and the U.S.) has shown it to be safe and effective for HDV patients. If the European Commission fully approves Hepcludex, it will be the only authorized HDV treatment available in Europe (Dunleavey, 2023).  

Lonafarnib 

At the end of 2022, Eiger Biopharmaceuticals announced that lonafarnib reached an important milestone in its phase 3 trial.  

The trial includes two regimens in patients with chronic HDV:  

  1. 1. Lonafarnib boosted with ritonavir, a protease inhibitor, which interferes with the ability of certain enzymes to break down proteins, often used in combination with other therapies for antiviral activity (this is an all-oral therapy), and
  2. 2. Lonafarnib in combination peginterferon alfa, an antiviral and immunosuppressive, which either completely or partially suppresses the immune system, often used to treat hepatitis B (HBV) and hepatitis C (HCV) patients (this is a combination therapy).

Both treatment arms showed statistical significance over the placebo arm of the trial. The placebo arm is used as a control in drug testing and has no therapeutic effect on patients. The results showed three noteworthy findings: 1. After 48 weeks (about 11 months) of treatment with the all-oral regimen, a small number of patients may achieve reduced viral load and improved liver function. 2. Combining lonafarnib and ritonavir with peginterferon alfa showed the potential to almost double the effectiveness of the drugs. 3. Combination treatment may lead to significant liver tissue improvement. Researchers found that most adverse symptoms related to treatment were either mild or moderate in severity, with gastrointestinal issues being the most frequent (Eiger Biopharmaceuticals, 2022). 

Peginterferon Lambda 

In June 2023, the results of a phase 2 trial looking at the safety and efficacy of peginterferon lambda (also an Eiger Biopharmaceuticals product) in HDV patients were published. Previously, peginterferon lambda showed a good tolerability profile (or the degree to which patients can tolerate negative treatment symptoms) in patients with HBV and HCV when compared to peginterferon alfa. In this trial, patients received 120-mcg or 180-mcg peginterferon lambda injections over 48 weeks, followed by 24 weeks of post-treatment follow-up. Researchers found that 180-mcg injections were more effective in HDV patients compared to the 120-mcg injections group. Results showed that with 48 weeks of 180 mcg treatment, patients showed a significant reduction in HDV RNA, the molecules responsible for perpetuating the virus in HDV patients. 36% of patients’ HDV RNA levels were undetectable. Some of the adverse symptoms patients experienced were flu-like symptoms and elevated transaminase levels, or enzymes that are related to a fatty liver. Most adverse symptoms were mild or moderate in nature and were resolved without additional treatment (Etzion et al, 2023). 

These three drug therapies show promise for HDV patients. Hepcludex is well on its way to becoming fully authorized in Europe after its three-year conditional approval and recent Phase 3 trial results. Lonafarnib’s phase 3 trial results are encouraging and Eiger, its manufacturer, plans to begin meeting with regulatory agencies, such as FDA and EMA, to discuss regulatory submissions (Eiger Biopharmaceuticals, 2022). Peginterferon lambda has shown a higher tolerability in patients with a lower adverse event rate than peginterferon alfa, which has been modestly used for the treatment of HDV over the past several decades (Etzion et al, 2023). Peginterferon lambda still has a ways to go before regulatory discussions, considering that results have just been published from its Phase 2 trial. Typically, in Phase 2 trials, researchers seek to learn whether the treatment they are studying is effective in fighting the disease. Phase 3 will test whether peginterferon lambda is more effective than already available, standard treatments. Hopefully, these three drugs continue to show positive results for HDV patients and will become widely available over the next few years. There are a number of other HDV drugs currently in development, but these are still in the early stages of clinical trial testing. You can stay up to date on the latest developments of these drugs by checking out the Hepatitis Delta Connect Drug Watch page. 

Dunleavy, K. (2022, October 28). Gilead hits surprise FDA rejection for hepatitis D drug already authorized in Europe for 2 Years. Fierce Pharma. https://www.fiercepharma.com/pharma/gilead-gets-fda-rejection-hepatitis-d-drug-already-authorized-europe-two-years 

Dunleavy, K. (2023, May 5). After FDA rejection, Gilead’s Hepcludex looks set for full EU NOD. Fierce Pharma. https://www.fiercepharma.com/pharma/gileads-hdv-drug-hepcludex-gets-thumbs-chmp 

Eiger announces both lonafarnib-based treatments in pivotal phase 3 D-LIVR trial in Hepatitis Delta virus (HDV) achieved statistical significance against Placebo in composite primary endpoint. Eiger BioPharmaceuticals. (n.d.). https://ir.eigerbio.com/news-releases/news-release-details/eiger-announces-both-lonafarnib-based-treatments-pivotal-phase-3 

Etzion, O., Hamid, S., Lurie, Y., Gane, E. J., Yardeni, D., Duehren, S., Bader, N., Nevo-Shor, A., Channa, S. M., Cotler, S. J., Mawani, M., Parkash, O., Dahari, H., Choong, I., & Glenn, J. S. (2023). Treatment of chronic hepatitis D with peginterferon lambda-the phase 2 LIMT-1 clinical trial. Hepatology (Baltimore, Md.), 77(6), 2093–2103. https://doi.org/10.1097/HEP.0000000000000309  

MYR Pharmaceuticals. (2020, September 17). Myr Pharmaceuticals launches HEPCLUDEX® in Germany, France and Austria. PR Newswire: press release distribution, targeting, monitoring and marketing. https://www.prnewswire.com/news-releases/myr-pharmaceuticals-launches-hepcludex-in-germany-france-and-austria-301133006.html 

Results from Hepatitis Delta Clinical Trials Announced at International Liver Congress 2022

London, UK was the host city for this year’s annual International Liver Congress (ILC), the yearly meeting of the European Association for the Study of the Liver (EASL), which took place from June 22nd-26th. This meeting provides an opportunity for those working to address liver diseases around the world to gather in one location and exchange ideas, present research, and work to advance diagnosis, prevention, treatment, and elimination of these serious conditions. This year’s meeting saw significant attention given to hepatitis delta, as new treatments continue to move through the pipeline and more widespread approval for prescription of current treatments is sought. Below is a quick snapshot of some of the presentations!

The US-based pharmaceutical company Gilead Sciences, Inc. demonstrated with results from a Phase 3 clinical trial that treatment with Hepcludex (bulevirtide), the first medication ever approved for hepatitis delta (HDV), has been shown to achieve significant response in chronic HDV. After 48 weeks, 48% of study participants who received different doses of treatment with Hepcludex achieved virological response (meaning a decline in hepatitis delta viral load, ALT normalization, and a change in liver stiffness), compared to only 2% of those who had not received any treatment. When compared to results from clinical trials after 24 weeks, response rates to HDV only improved, showing the drug to be even more effective over time. Throughout the clinical trials, there have been no adverse events reported that are attributable to this treatment.

Hepcludex has also been found to have a positive impact on the quality of life of individuals living with hepatitis delta, and their overall ability to manage the condition. There were improvements found in health distress, performance of daily activities related to hepatitis, emotional impact of hepatitis, and ability to work. This data reinforces the efficacy and safety of Hepcludex and hopefully strengthens the case for approving the drug in more parts of the world.

“As the most severe form of viral hepatitis, HDV presents a significant disease burden with high healthcare-related costs and until recently, no approved treatment options,” said Heiner Wedemeyer, MD, Director, Clinic for Gastroenterology, Hepatology and Endocrinology at Hannover Medical School, and principal investigator of the study. “These results presented at ILC 2022 not only highlight the important clinical role that bulevirtide has to play as a safe and effective treatment option for chronic HDV, but critically also demonstrate that with prolonged treatment, we can achieve higher response rates so we can better manage this rare, life-threatening disease in more people.”

Presently, Hepcludex has been conditionally approved by the European Commission for prescription in France, Germany, and Austria. It has not yet been approved by the United States Food and Drug Administration (FDA) or in other countries. A Biologics License Application was submitted by Gilead to the FDA in late 2021 for injection of 2mg of Hepcludex to treat adults with HDV and compensated liver disease. Hepcludex had previously been granted Breakthrough Therapy and Orphan Drug designations by the FDA and PRIority MEdicines (PRIME) scheme eligibility by the European Medicines Agency (EMA).

The second company to present their research findings at the ILC was US-based Eiger BioPharmaceuticals, Inc. The two primary hepatitis delta drugs that they have in the pipeline are called lonafarnib and peginterferon lambda. One abstract presentation indicated that peginterferon lambda (lambda) had better antiviral activity and tolerability than peginterferon alfa (the previous version of this drug that has been used as the only somewhat effective, but off-label treatment for hepatitis delta since the early 1980s). Lambda has been shown to block production of new hepatitis delta virus very effectively. Additionally, lambda in combination with lonafarnib was found to lower levels of HDV RNA and decrease its production and release, more effectively than lambda by itself. Patterns in HBV DNA, hepatitis B surface antigen, and ALT were also observed as part of this study. In its Phase 3 D-LIVR study, which is assessing the safety and efficacy of lonafarnib in combination with ritonavir, with and without peginterferon alfa, Eiger has assembled the largest cohort of global participants in an HDV study, and therefore the largest body of data. Results from this study are anticipated by the end of 2022.

The final piece of big hepatitis delta news to come out of the conference was the announcement from Vir Biotechnology Inc. that they are beginning a Phase 2 clinical trial for VIR-2218 in combination with VIR-3434 for the treatment of chronic hepatitis delta. Initial data from this study is anticipated in 2023.

Hepatitis delta is now receiving more attention than ever before and there is only more hope as new treatments are created, investigated, approved, and made available. For a complete overview of hepatitis delta, including basic information, resources, clinical trial opportunities, and a complete list of drugs that are in the pipeline, visit www.hepdconnect.org.

References

https://www.gilead.com/news-and-press/press-room/press-releases/2022/6/treatment-with-hepcludex-bulevirtide-meets-primary-endpoint-and-achieves-significant-response-in-chronic-hepatitis-delta-virus-at-48-weeks

https://www.streetinsider.com/Corporate+News/Vir+Biotechnology+Inc.+%28VIR%29+Announces+New+Clinical+Data+From+its+Broad+Hepatitis+B+Program/20256465.html

https://www.prnewswire.com/news-releases/eiger-biopharmaceuticals-announces-results-from-multiple-presentations-at-the-european-association-for-the-study-of-the-liver-easl-international-liver-congress-2022-301576119.html

2022 – The Year of Hepatitis Delta

2022 is shaping up to be a big year for hepatitis delta, the rare but serious virus that can co-infect people who are already living with hepatitis B. As a quick refresher, hepatitis delta is a virus that depends upon the hepatitis B virus in order to survive and replicate – so only those who are already living with hepatitis B can become infected with hepatitis delta. Hepatitis delta virus (HDV) is believed to infect between 5 and 10% of people living with hepatitis B virus (HBV). HDV can occur through either a superinfection or a coinfection. A superinfection occurs when someone who is already living with HBV contracts HDV, in which case there is a very high chance that the individual will develop chronic (lifelong) infections of both HBV and HDV. A coinfection occurs when both HBV and HDV are contracted at the same time – when this happens in adults, both infections tend to clear within six months and there is only a 5% chance that chronic HBV and HDV will occur. Chronic HDV is particularly dangerous because it advances progression to serious liver damage and liver failure much more quickly than HBV alone – 70% of people diagnosed with HDV and HBV will experience serious liver damage within 10 years without intervention, compared to 15-30% of people diagnosed with HBV alone.

So, What’s Happening in the World of Hepatitis Delta?

The past 18 months have been very important for hepatitis delta research and drug development. In July of 2020, the European Medicines Agency approved Hepcludex, the first-ever drug approved for treatment of hepatitis delta, for prescription in France, Austria, and Germany. Hepcludex works by stopping HDV from entering and infecting liver cells (and is known as an entry inhibitor). In 2021, MYR Pharma, the German company that originally developed Hepcludex, was bought by Gilead Sciences, Inc., which is based in the United States, and which has since filed a Biologics Licensing Agreement for approval of Hepcludex by the US Food and Drug Administration, which is expected later this year. At this time, there is not a timeline for when Hepcludex approval will be expanded to more countries and parts of the world. Prior to Hepcludex, the only drug available for hepatitis delta management, which was never officially approved, was called pegylated interferon alpha. This drug, still in use today, is only effective in controlling HDV in about 25% of people living with the virus and has challenging side effects that can negatively impact quality of life.

In addition to Hepcludex, two other promising drugs are in clinical trials, both developed by Eiger BioPharma in the United States. The first of these is called Lonafarnib, which is being evaluated for how well it works to target the protein assembly process, which keeps new viruses from being created (it is known as a prenylation inhibitor). Lonafarnib, in combination with another drug called Ritonavir, is currently in Phase III clinical trials (the phase in which the safety and effectiveness of a drug is compared to that of currently available treatments). These trials are fully enrolled, and data is expected by the end of 2022. Additionally, Eiger is currently enrolling phase III clinical trials for Pegylated Interferon Lambda, which works by stimulating the body’s own immune system to fight the virus. For a full list of drugs under investigation for hepatitis delta, including one from Janssen Research and Development and one from Antios Therapeutics, visit our Drug Watch page.

Are There Other Clinical Trials Happening for Hepatitis Delta?

 Yes! There are clinical trials happening worldwide to test many of the drugs listed above and more. You can check out our clinical trials page here. This page includes a detailed description of each clinical trial, along with information about where it is being conducted and how to contact the principal investigator (or person leading the clinical trial). This page also includes a helpful graphic describing the clinical trial process and what it takes for a drug to move from an idea into the real world. It is important to note that not all of the trials listed here are for the purpose of testing a medication – some are observational studies to monitor what are called disease biomarkers, which are physical measures used to monitor the progress of a disease and could include tests of blood or liver function, for example. Clinical trials are currently happening in Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, France, Georgia, Germany, Greece, Israel, Italy, Japan, Mongolia, New Zealand, Pakistan, Republic of Moldova, Romania, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, the United Kingdom, the United States, and Vietnam.

When Will HDV Drugs and Clinical Trials Be More Accessible in More Parts of the World?

 This is unfortunately a difficult question to answer. Even though up to 10% of people who are living with hepatitis B are also living with hepatitis delta, there are not good systems in place to make sure that everyone who is living with HBV or who is at increased risk for HDV is tested and diagnosed, so there are not very accurate numbers about how many people in the world are living with HDV. Indeed, of the nearly 300 million people around the world who are living with hepatitis B alone, only 10% are aware of their diagnosis, so this number is undoubtedly far lower than even 10% for hepatitis delta. Without accurate information about how many people are living with the virus, it is difficult for drug and clinical trial developers to invest resources into studying or pursuing drug development or clinical trials for HDV.

Another problem is the many resources of time, money, and labor that are necessary for developing drugs, and preparing and running clinical trials. The development process for a single drug can take anywhere from 5-15 years and a much larger number of drugs fail to complete this process than succeed. Additionally, there needs to be some degree of existing infrastructure in a particular country in order to both support a clinical trial and ultimately to get a drug approved. Unfortunately, this kind of infrastructure is generally already established and easier to navigate in wealthier countries, so these are the countries in which clinical trials are generally held and in which drug approvals tend to happen first. Public health and clinical infrastructure is slowly developing and becoming more prioritized in different parts of the world and hopefully this trend will continue, but for the time being, the locations of clinical trials and approvals for important treatments point to the much larger issues of lack of access to health and healthcare in much of the world, that in turn stem from deep-seated poverty and inequity. Again, as health equity continues to be a focus of the public eye, these trends will hopefully begin to change, paving the way for greater access to healthcare for hepatitis delta, hepatitis B, and countless other health conditions.

What Is Hep Delta Connect’s Role?

 This year, Hep Delta Connect will continue its work to raise the profile of hepatitis delta, both in the United States and around the world. We are committed to building awareness through partnerships with community-based organizations, healthcare providers, and governmental agencies around the world and through dissemination of educational materials and programming. We hope to foster greater engagement of those living with and affected by hepatitis delta globally, more focused advocacy efforts to bring HDV into the spotlight, and increased screening, diagnosis, and management of HDV. We keep our website and social media channels updated regularly with program news and events – make sure to follow us on Facebook, Twitter, and Instagram and check out our website frequently! You are always welcome to connect with us anytime at connect@hepdconnect.org. We look forward to an exciting year of work on HDV!

GlaxoSmithKline Recruiting for B-Together Hep B Clinical Trials

The company GlaxoSmithKline (GSK) is launching a new clinical trial, called B-Together, that will investigate how two study drugs might work together to treat chronic hepatitis B (CHB). Researchers are hoping to find new potential treatments that could be more effective than those that are currently available and could lead to positive results that last long after the treatment ends. Participants in this trial could play a role in shaping science and changing the landscape of CHB treatment around the world, and will have an opportunity to learn more about the disease itself.

The two drugs that will be investigated in this trial are GSK3228836 and pegylated interferon, also known as Pegasys. In a previous Phase 2 trial, people living with CHB received GSK3228836 for 4 weeks. The Phase 2b B-Together trial will test longer treatment with GSK3228836, followed by Pegasys, to see what effects this may have on viral antigens (such as HBsAg) in the body. 

About the Study Drugs

GSK3228836 is an investigational drug being tested as a potential treatment for CHB, meaning it is not yet approved for this purpose. Current medicines available to treat CHB only stop the virus from multiplying – they do not enable the body to fully clear the infection, so people have to keep taking these medicines. GSK3228836 is designed to stop the virus from producing proteins that may prevent the immune system from fighting the virus. Thus, the study drug may potentially allow the body to gain control over the infection.

The other drug used in this study, Pegasys, is a medicine that is already used on its own by doctors to treat CHB. Pegasys works by enhancing the body’s immune response to viral infections such as hepatitis B.

What Will Happen During This Trial?

During this trial, all participants will receive GSK3228836 followed by Pegasys. After you have finished treatment with GSK3228836, your doctor will check if it is appropriate for you to start treatment with Pegasys. If it is not appropriate, you may not receive Pegasys at all. At the beginning of the trial, you will be assigned by chance to one of two groups. Each group will receive the study drugs for different lengths of time. You will know which group you are in. The B-Together trial lasts about 79 weeks for each participant. This includes a screening period, a study treatment period, and a follow-up period.

Screening Period

At a screening visit, the study doctor will give you a physical examination, ask about your medical history, and conduct medical tests. The screening period may last up to about 6.5 weeks while the study doctor reviews the results of your screening visit to determine if you meet all requirements for participation.

Trial Treatment period

While receiving GSK3228836, you will visit the clinic for either 12 or 24 weeks. For the first two weeks of your treatment with GSK3228836, you will visit twice per week and for the remaining weeks you will visit the clinic once per week.

When you have finished treatment with GSK3228836, your doctor will assess if it is appropriate for you to start treatment with Pegasys. If it is appropriate, then you will then receive treatment  with Pegasys once a week for up to 24 weeks.

In some countries, it will be possible for you to self-inject Pegasys at home after discussion and training from your study doctor. This could reduce the number of times you have to visit the clinic.

Other study activities will vary from visit to visit and may include:

  •         Discussions about your health and medications you may take outside the trial
  •         Measurement of vital signs (i.e. blood pressure, pulse, weight)
  •         Collection of blood or urine samples
  •         Physical examination
  •         Questionnaires about your health and well-being

Follow-Up Period

During the 24-week follow-up period, you will not receive injections of study treatment, but you will complete other study visit activities as scheduled. There are eight visits scheduled in the follow up period. Your study participation will end about 72 weeks after your first dose of the trial drug.

Who Can Participate?

You may be eligible to participate in this trial if you are at least 18 years old, have been living with documented CHB for at least six months, and have also been receiving stable nucleos(t)ide treatment (not telbivudine) with no changes for at least six months prior to screening and no planned changes for the duration of the study. There are other eligibility requirements that the study doctor will review with you. Individuals who have a current co-infection with or past history of hepatitis C virus, HIV or hepatitis D virus are not eligible to participate in this trial. 

Where Is This Trial Taking Place?

This trial is ongoing in the UK, Spain, Russia, Poland, Italy, Korea, Japan, China, the US, Canada, and South Africa.

You can play a role in shaping your own health and the science of tomorrow! To learn more about this trial and check your eligibility to participate, visit https://clinicaltrials.gov/ct2/show/NCT04676724

Announcing New Liver Cancer Clinical Trials

Over the past few decades, there have been several advancements in liver cancer research and treatment. These have included improvements in chemotherapy treatments that can now successfully shrink tumors to a size at which they can be more easily surgically removed, and the development of therapies that block blood flow to tumors. Liver ablation (tissue removal) and transplantation techniques have also been greatly improved in recent years (Johns Hopkins Medicine, 2020). Many of these advancements would not have been possible without the help of clinical trial volunteers with liver cancer. Your contribution is important and valuable and may help research for the future. Learn more about these opportunities today.

The pharmaceutical company Bristol Myers Squibb (BMS) is now enrolling for two clinical studies in liver cancer (also called hepatocellular carcinoma or HCC). These trials have the reference numbers CA209-9DW and CA209-74W. If eligible and you are willing and able to take part, you will be helping to advance research.

One of these trials is researching a study drug called nivolumab. Researchers want to find out how well the study drug works, both with and without ipilimumab in combination with trans-arterial ChemoEmbolization (TACE), when compared to TACE alone in participants with intermediate-stage HCC. Eligible trial participants must be at least age 18 years old and must not have had a liver transplant, or be on the waiting list for a liver transplant. This is not a full list of trial requirements.

Another trial is researching nivolumab in combination with another study drug called ipilimumab (also called Yervoy) in participants with advanced HCC. Researchers in this trial want to find out how well this study drug combination works when compared to other drugs called sorafenib or lenvatinib. Eligible trial participants must be at least 18 years old and must not have had any type of prior chemotherapy. This is not a full list of trial requirements.

For more details about each trial, including full trial requirements, lists of tests and procedures used to determine trial eligibility, and more details about Bristol Myers Squibb, please visit the BMSStudyConnect website.

Before you decide to enroll in a clinical trial, you can download the Study Participant’s Guide. This guide is available in many languages on this site, and includes information about trial participation, why clinical studies are important, questions to ask your doctor before participating, guidance on transportation and lodging during a clinical trial, helpful tips on how to prepare to take part in a trial, and links to helpful resources.

References

Johns Hopkins Medicine. (2020). 4 Liver Cancer Treatment Advances. https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/4-liver-cancer-treatment-advances.