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Hepatitis B clinical trials at UCSF
15 in progress, 4 open to new patients

  • Hepatitis B Research Network Adult Cohort Study

    open to eligible people ages 18 years and up

    The primary purpose of this study is to describe participants with hepatitis B virus (HBV) infection and identify factors that may cause the disease to activate or worsen.

    San Francisco, California and other locations

  • Hepatitis B Research Network Pediatric Cohort Study (HBRN)

    open to eligible people ages 6 months to 17 years

    The purpose of this study is to describe participants 6 months to <18 years of age with hepatitis B virus (HBV) infection in a prospective cohort in the United States (US) and Canada and identify predictors of disease activation and progression.

    San Francisco, California and other locations

  • Tenofovir Alafenamide (TAF) in Adolescents With Chronic Hepatitis B Virus Infection

    open to eligible people ages 12–17

    The primary objectives of this study are as follows: Part A: To evaluate the steady state pharmacokinetics (PK) of tenofovir alafenamide (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) 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.

    San Francisco, California and other locations

  • The "HBV eAg- Disease-Directly Offers" Study: Treatment Withdrawal in Patients With Early-Antigen Negative Chronic HBV

    open to eligible people ages 18–67

    The investigators' research is aimed at developing more effective, finite approaches for managing individual patients with chronic hepatitis B (CHB). This prospective clinical and basic scientific study exclusively focuses on patients with the early antigen negative form of disease, which in developed countries is treated indefinitely with antiviral drugs. The investigators' study "BeNEG-DO," directly offers patients who are already taking standard oral Hepatitis B Virus (HBV) antiviral therapy for at least 192 weeks the option to stop or continue treatment. Drawing on data from pilot studies, including the investigators' own University of California, San Francisco and Sutter Institutional Review Board-approved study, the investigators will examine a finite HBV treatment strategy on clinical outcome and safety. In conjunction, the investigators will study immunologic mechanisms and gene expression profiles that correlate with and predict the post-treatment clinical course. The BeNEG-DO study could seriously question, and potentially change, the current treatment paradigm for millions of patients with CHB and also lead to new disease-terminating antiviral therapeutics.

    San Francisco, California and other locations

  • A Study of Pegylated Interferon Alfa-2A in Combination With Lamivudine or Entecavir Compared With Untreated Control Group in Children With Hepatitis B Envelope Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB) in the Immune-Tolerant Phase

    Sorry, not recruiting here

    This randomized, controlled, parallel group, open-label multicenter study will evaluate the efficacy and safety of a combination of pegylated interferon alfa-2A (Pegasys) plus lamivudine or entecavir compared with an untreated control group in participants with HBeAg positive CHB in the immune tolerant phase.

    San Francisco, California and other locations

  • A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus Infection

    Sorry, in progress, not accepting new patients

    The purpose of this study was to evaluate the safety and efficacy of entecavir in pediatric patients with chronic hepatitis B virus infection

    San Francisco, California and other locations

  • A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection

    Sorry, in progress, not accepting new patients

    The purpose of this clinical study is to determine the appropriate doses of entecavir to use in children and adolescents. Safety, tolerability and efficacy will also be studied

    San Francisco, California and other locations

  • A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B

    Sorry, in progress, not accepting new patients

    This parallel group, open label study will evaluate the safety and efficacy of Pegasys (peginterferon alfa-2a) versus untreated control in children (age 3 years to <18 years at baseline) with HBeAg positive chronic hepatitis B. Children without advanced fibrosis and without cirrhosis will be randomized 2:1 to treatment Group A, receiving Pegasys 45-180 mcg subcutaneously weekly for 48 weeks, or to the untreated control Group B. Children with advanced fibrosis will be assigned to treatment group C and receive 48 weeks of treatment with Pegasys. Children in the untreated control Group B who have not experienced seroconversion 48 weeks after randomization may enter the Switch Arm to receive 48 weeks of Pegasys treatment. This offer will be available for 1 year following 48 weeks from randomization. Anticipated time on study treatment is 48 weeks. All subjects will be followed up for 5 years after the end of treatment (A,C,Switch)/principal observation (B) period.

    San Francisco, California and other locations

  • Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B

    Sorry, in progress, not accepting new patients

    This clinical trial compares the efficacy of peginterferon plus tenofovir for 24 weeks followed by monotherapy with tenofovir for a further 3.5 years to the efficacy of tenofovir alone given for 4 years in patients with chronic hepatitis B. The primary measure of outcome will be HBsAg loss in serum at 48 weeks after stopping all antiviral therapy (sustained off-treatment response).

    San Francisco, California and other locations

  • Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection

    Sorry, in progress, not accepting new patients

    The purpose of this study is to determine the safety and efficacy of treatment using a combination of drugs (entecavir and pegylated interferon) in children ages 3-<18 years old with immunotolerant chronic hepatitis B.

    San Francisco, California and other locations

  • Evaluating the Efficacy, Safety and Tolerability of Tenofovir DF in Pediatric Patients With Chronic Hepatitis B Infection

    Sorry, in progress, not accepting new patients

    This placebo-controlled study evaluates the efficacy, safety and tolerability of tenofovir disoproxil fumarate (TDF) in participants 2 to < 12 years old with chronic Hepatitis B infection. While studies have shown significant virologic response in adults and adolescents, the effect in children is not well established. This study will provide valuable data that can help establish the efficacy and safety profiles of TDF in children. The study will consist of 48 weeks of blinded randomized treatment, after which participants will switch to open-label TDF treatment for an additional 144 weeks.

    San Francisco, California and other locations

  • HBRN: Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of Chronic Hepatitis B

    Sorry, in progress, not accepting new patients

    This is an ancillary to the NIDDK-sponsored treatment trials titled: Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B (NCT01369212) and Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults With Chronic Hepatitis B (NCT01369199). This study will examine the balance between immune regulatory and effector responses in hepatitis B-infected participants enrolled in the HBRN's clinical trials (NCT01369212 and NCT01369199) to define natural history and treatment outcome.

    San Francisco, California and other locations

  • HBRN: Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B

    Sorry, in progress, not accepting new patients

    This is an ancillary to the NIDDK-sponsored Hepatitis B Research Network (HBRN) Study Cohort Study NCT01263587. This study will examine the balance between immune regulatory and effector responses in hepatitis B-infected participants enrolled in the HBRN study (NCT01263587).

    San Francisco, California and other locations

  • Patient-Centered Care and Asian Americans

    Sorry, in progress, not accepting new patients

    Liver cancer and hepatitis B are major health disparities for Asian Americans, while hepatitis C is a rising problem. Little is known about how to improve the quality of health care Asian Americans receive in general and for viral hepatitis in particular. Technology, specifically mobile applications, potentially can provide a flexible and efficient way to address these challenges. This proposed project seeks to develop, implement, and test an intervention to increase hepatitis B and C screening for Asian Americans in 2 healthcare systems in the San Francisco Bay Area. The research team will develop, implement, and evaluate the efficacy of an interactive, patient- centered mobile application for use on a tablet computer to increase the rate of hepatitis B and C screening among unscreened Asian Americans age 18 and older. The team will use their experience from a successful track record in health promotion to develop the intervention by working with patients, community leaders and advocates, clinical staff, healthcare providers, and healthcare system administrators from a county safety net system and an academic primary care practice in the San Francisco Bay Area. The mobile application will include video clips with a physician (Video Doctor) addressing patient concerns regarding hepatitis B and C screening in the patient's preferred language, English, Chinese, or Vietnamese. A patient who has not been screened for hepatitis B will answer questions about his or her characteristics and preferences using the mobile application. The mobile application will then show 30-60 seconds video clips with messages that address the patient's responses related to hepatitis B screening and that are delivered by an actor playing a physician. Those who are born between 1945 and 1965 also receive messages about hepatitis C screening. At the end, the tablet computer will generate a provider alert to let the treating provider know what the patient's preferences are regarding testing for viral hepatitis. Once developed, the intervention will then be used in combination with a physician panel notification and tested against physician panel notification only in a randomized controlled trial to see which approach is better in increasing the rate of hepatitis B and C screening. The team will also work with the 2 healthcare system to ensure that the interventions will be practical and easily adopted once the study is over. The findings of this project will greatly expand understanding about how to use technology- based interventions to improve quality of healthcare in diverse patient populations.

    San Francisco, California and other locations

  • Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Negative Hepatitis B

    Sorry, in progress, not accepting new patients

    The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B virus (HBV) infection.

    San Francisco, California and other locations