Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination With Peginterferon α-2a vs Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon α-2a Monotherapy for 48 Weeks in Chronic Hepatitis B
Study Status
Closed to Enrollment
Study Description
Full study title: A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination With Peginterferon α-2a (Pegasys) Versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon α-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects With HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB)
This study involves a daily pill which is a commercially available drug named tenofovir DF (TDF) for the treatment of chronic Hepatitis B virus. This drug TDF will be given alone or in combination with a weekly shot of another commercially available drug called Pegylated Interferon alfa (PEG). Both drugs have been shown to be good at lowering the amount of virus in the blood on their own. This study will see if they work better together than they do alone.
This is a randomized, open-label, active-controlled, superiority study to evaluate safety and the proportion of subjects with HBsAg loss in subjects who were treated with combination of TDF plus PEG versus standard of care TDF or PEG for 48 weeks.
The purpose of this study is to see:
- If it is more effective to give a combination of TDF and PEG together for 48 weeks versus TDF given alone or PEG given alone, also for 48 weeks. The efficacy will be measured by comparing how many subjects in each study arm succeed in getting rid of Hepatitis B “S antigen” (a protein associated with the hepatitis B virus) from the blood.
- If combination rather than single therapy helps more subjects have low amounts of virus in the blood, both when they are on study drug, and if they stop study drug (in a study arm in which in subjects stop study drug).
- If more subject in combination study drug therapy stop making a virus protein called Hepatitis B “E antigen” compared to those who are on single therapy. In subjects who stop making the virus protein, does the body also start making antibodies against this virus protein.
- In subjects who lose S antigen in the blood: Can the study drug be safely stopped, or do these subjects need more study drug to prevent the virus from coming back?
- If liver inflammation (measured by a liver enzyme called ALT) is more effectively reduced by combination versus single therapy.
- If subjects with different responses to study drug can be selected by finding “biomarkers” (molecules in the body that are markers of the subject’s response and/or ability to respond to study drug therapy).
If the subject agrees to participate, they will be one of 720 subjects at approximately 150 sites in Europe, North America, Australia, and Asia who will be given TDF and PEG in combination or one of the two study arm treatments as a single therapy. Since this is an open label study, subjects will know what combination or single agent study drug they will be taking. This is also a randomized study, which means the subject will be selected by chance (like flipping a coin) to receive one of 4 study arm treatments. The four study arm treatments are listed below:
Arm A: 180 Subjects will be treated with TDF and PEG in combination for 48 weeks
Arm B: 180 Subjects will be treated with TDF and PEG in combination for 16 weeks followed by TDF alone for another up to 32 weeks (total 48 weeks of treatment)
Arm C: 180 Subjects will be treated with TDF alone continuously through 120 weeks
Arm D: 180 Subjects will be treated with PEG alone for 48 weeks
The randomization for this study is in a 1:1:1:1 ratio which means the subject will have 2 out of 4 chances to receive the combination study drug treatment and 2 out of 4 chances to receive either TDF or PEG as a single therapy.
Disease Status and/or Stage
Chronic Hepatitis B
Sponsor
Gilead Sciences, Inc.
Key Eligibility
- Men and women age 18 to 75
- Chronic Hepatitis B (positive for serum HBsAg for at least 6 months)
- Anti-hepatitis B (HBV) treatment naive; subjects who have taken < 12 weeks of oral anti-HVB nucleoside therapy with the last dose ≥ 24 weeks prior to screening are also eligible
- Positive or negative for HBeAg
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- Hepatitis C Research Team
- 646-962-HEPC (4372)
Healthy Volunteers
As a healthy volunteer in a clinical trial you may make a significant contribution to the discovery of medical knowledge and new treatments that could impact people around the world.
Click here for studies seeking healthy volunteers.
Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]
