Adults (U.S.)

*CHB=Chronic hepatitis B

For trials listed as "International" or "International Only," click on the NCT identification number for a complete list of participating countries.

Long-Term Study of Liver Disease in People with Hepatitis B and/or Hepatitis C With or Without HIV Infection - U.S.
This study follows people with hepatitis B or C in order to understand how these viruses affect the immune system over the long term (up to 10 years). The study will also compare how these viruses affect people who do and do not have HIV, the virus that causes AIDS. Contact Rachel Silk at 202-857-5219 or silkr@mail.nih.gov or Dr. Colleen Hadigan at 301-594-5754 or hadiganc@mail.nih.gov and refer to identifier NCT01350648.

Thousand Asian American Study (TAAS) – U.S.
The “Thousand Asian American Study” aims to test 2,000 foreign-born and children of foreign-born Asian Americans residing in Sacramento Country and counsel at least 90% of those testing HBV positive. Contact: Julie Dang, MPH at 916-734-5222 jtdang@ucdavis.edu or Dr. Moon Chen Jr. at 916-734-1191 mschenjr@ucdavis.edu  and refer to identifier- NCT02596438  (Study ID #388325)

Clinical Performance Evaluation of DxN HBV Assay – U.S. and Canada

The DxN Hepatitis B Virus (HBV) assay (test) is an in vitro diagnostic assay to aid in the management of HBV-infected individuals undergoing antiviral therapy. The purpose of this study is to establish the clinical performance of the DxN HBV Assay for plasma samples in the intended use population. Contact Lori Lofaro, MSHS, at 760-438-6574 or email lrlofaro@beckman.com and refer to identifier NCT03123159.

Efficacy and Safety of Switching From Tenofovir to Tenofovir Alafenamide (TAF) in Adults With Chronic Hepatitis B Who Are Virologically Suppressed – U.S.

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching to TAF versus continuing tenofovir in virologically-suppressed adults with chronic hepatitis B. Contact: Gilead Study Team at GS-US-320-4018@gilead.com and refer to identifier NCT02979613.

The "HBeAg- Disease-Directly Offers" Study: Treatment Withdrawal in Patients With Early-Antigen Negative Chronic HBV (BeNEG-DO) – U.S.

This study focuses on patients receiving antivirals who have cleared the hepatitis B “e” antigen (HBeAg) early. The study offers patients who are taking antiviral therapy for at least 192 weeks the option to stop or continue treatment to evaluate the outcomes. The study could potentially change the current treatment paradigm and lead to new therapeutics. Contact: Jae Shin MPH at 415-407-9430 or email shinj3@sutterhealth.org or Margaret.simone@ucsf.edu and refer to identifier NCT02845401.

Identification of CHB Among Somali Immigrants in Minnesota Through Community Wide Screening – U.S. 
This study will fill gaps in the Somali population to determine US immigrant prevalence data and risk factors for HBV and HCV. Contact: Nasra Giama, DNP at 507-538-0097 giama.nasra@mayo.edu or Dr. Lewis Roberts at 507-538-4877 roberts.lewis@mayo.edu and refer to identifier- NCT02366286  (Study ID #09-001670, IN-US-174-0230)

Observational Study of Persons With Hepatitis B Virus Infection in North America – U.S.

Long-term study of those with chronic HBV to improve current knowledge on the disease and long-term disease progression. Contact: Nancy Fryzek at 301-435-6122 nancy.fryzek@nih.gov or Dr. Marc Ghany at 301-402-5115 mg228m@nih.gov and refer to identifier - NCT01306071 (Study ID # 110108, 11-DK-0108)

Evaluation of Patients With Liver Disease – U.S.
Evaluate, investigate and follow-up patients suffering from acute and chronic liver disease. Qualified patients may be able to participate in other offered studies. Contact: Nancy Fryzek at 301-435-6122 nancy.fryzek@nih.gov or Dr. T. Jake Liang at 301-496-1721 jakel@mail.nih.gov. Refer to identifier - NCT00001971 (Study ID # 910214, 91-DK-0214)

Mechanisms Associated With Favorable Responses to Peginterferon-Alpha Add-on Therapy Following Long-term Nucleos(t)Ide Analogue Treatment in Patients With Chronic Hepatitis B – U.S.

Evaluate if peginterferon might help treat people with chronic and to understand how peginterferon might help treat adults with chronic hepatitis B. Also, to see if peginterferon is safe to use with other antiviral medications. Contact: Nancy Fryzek at 301-435-6122 nancy.fryzek@nih.gov or Dr. Marc Ghany at 301-402-5115 mg228m@nih.gov and refer to identifier - NCT02364336 (Study ID # 150082 15-DK-0082)

Phase I Study of INO-1800 With or without INO-9112 +EP in CHB Patients – U.S. and International
Evaluate safety, tolerability and immunogenicity of dose combinations of INO-1800 (DNA plasmids encoding HBsAg and HBcAg) and INO-9112 (DNA plasmid encoding human interleukin 12) delivered by electroporation in entecavir or tenofovir treated patients. Contact: Mandeep Kaushal at +61 (0) 3 8401 3797 or mandeep.kaushal@quintiles.com and refer to identifier- NCT02431312 (Study ID# HBV-001)

Efficacy and Safety of Switching from Tenofovir to Tenofovir Alafenamide (TAF) in Adults with Chronic Hepatitis B Who Are Virologically Suppressed – U.S. and Canada

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching to tenofovir alafenamide (TAF) versus continuing tenofovir disoproxil fumarate (TDF) in virologically suppressed adults with chronic hepatitis B virus (HBV) infection. Contact: Gilead Study Team at GS-US-320-4018@gilead.com and refer to identifier NCT02979613.

Hepatitis B Research Network Adult Cohort Study (HBRN) – U.S. and Canada

A study to identify factors that cause HBV disease to activate or worsen. Contact: Michelle Danielson, PhD or Andrew Pelesko, BS at 412-383-9584 HBRNDCC@edc.pitt.edu and refer to identifier -NCT01263587 (Study ID # DK082864, U01DK082864)