Children

*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.

Hepatitis B Research Network Pediatric Cohort Study (HBRN) –U.S. and Canada
This trial is for children and teens, 6 months to 18 years of age, with hepatitis B in a prospective cohort in the U.S. and Canada to help predict disease activation and progression. Contact: Refer to contact information for individual sites and refer to identifier – NCT01263600 (Study ID # DK082864Pediatric U01DK082864)

Tenofovir Alafenamide (TAF) in Adolescents (12-17) With Chronic Hepatitis B Virus Infection – U.S.
The primary objectives of this study are: Part A: To evaluate the steady state pharmacokinetics (PK) of tenofoviralafenamide (TAF) and confirm the dose of TAF 25 mg tablet given once daily in treatment-naive and treatment-experienced adolescents (aged 12 to < 18 years) with chronic hepatitis B (CHB), and
Part B: To evaluate the safety, tolerability, and antiviral activity (HBV DNA < 20 IU/mL) of TAF 25 mg once daily versus placebo through Week 24 in treatment-naive and treatment-experienced adolescents with CHB. Contact: Gilead Study Team at GS-US-320-1092@gilead.com and refer to indicator NCT02932150.

Non-invasive Biomarkers of Fibrosis in Pediatric Viral Hepatitis –U.S.
This study is being conducted to develop new techniques for early diagnosis of liver disease. These include ShearwaveElastography (SWE) ultrasound and blood biomarkers. Contact: Cynthia Tsai at 832-822-3634 ct2@bcm.edu or Dr. Daniel H Leung at dhleung@texaschildrens.org, 832-822-3606 and refer to identifier – NCT01988753 (Study ID # H-30472)

Pegasys in Combination with Lamivudine or Entacavir in Children with HBeAg Positive CHB in the Immune Tolerant Phase -U.S. and International
Evaluate the efficacy and safety of a combination of Pegasys plus lamivudine compared with an untreated control group in children with CHB in the immune tolerant phase, age 3-17. Contact: www.roche.com/about_roche/roche_worldwide.htm or 888-662-6728 (US only) global.rochegenentechtrials@roche.com and refer to Study ID # NV25361. Identifier – NCT02263079 (Study ID # NV25361, 2006-000977-31)

Pediatric Hepatitis B Research Network Study (HBRN) – U.S. and Canada
An NIH-funded study for children between 6 months and < 18 yrs. with HBV infection in a prospective cohort to identify predictors of disease activation and progression. Contact: Refer to contacts at individual locations by identifier – NCT01263600 (Study ID # DK082864Pediatric, U01DK082864.) Please click for HBRN details for parents and details for pediatric providers.

Tenofovir in Adolescents with CHB –International
Characterize the long-term bone safety profile of tenofovir DF in CHB infected adolescents 12 to 15 years of age. Contact: Gilead Study Team at GS-EU-174-1403@gilead.com and refer to NCT02479880 (Study ID: GS-EU-174-1403 2014-004939-39).

Rescue Treatment Pattern, Drug Resistance Recurrence, and Direct Medical Costs Associated With Chinese Patients With Chronic Hepatitis B and Drug Resistance to Nucleot(s)Ide Analogue Therapy (NAs resistance) – China
The purpose of this study is to describe current rescue treatment pattern for nucleot(s)ide analogue (NA) resistance and assess the real-world treatment outcomes and health resources utilization of rescue treatments for drug resistance in a clinical cohort of Chinese patients with chronic hepatitis B. All ages are eligible. Contact: Bristol-Myers Squibb at Clinical.Trials@bms.com and refer to identifier NCT02791386.

Evaluation of Paternal, Maternal and Obstetric Factors Leading to the Hepatitis B Immunization Failure in Hong Kong – China/Hong Kong
There are still a lot of uncertainties on how infants acquired HBV leading to the development of chronic HBV infection despite active and passive immunoprophylaxis. The investigators would like to carry out a prospective study to discover the paternal, maternal and obstetric factors leading to immunoprophylaxis failure, and the prevalence of immunoprophylaxis failure in Hong Kong. Contact: Ka Wang Cheung at (852) 22553111 or kelvincheung82@hotmail.com and refer to identifier NCT02443233.