Hep B Superiority Study, TDF & PEG in combination & monotherapy
Research type
Research Study
Full 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 a-2a (Pegasys®) versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon a-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects with HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB)
IRAS ID
75748
Contact name
Graham R Foster
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2010-024586-45
Clinicaltrials.gov Identifier
Research summary
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 a-2a (Pegasys©) versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon a-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects with HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB)-----------------------------------------------------------------------------Hepatitis B virus is carried in the bloodstream to the liver. In the UK this disease affects about 1 in 550 people.Treatment for hepatitis B does not cure the disease but aims to delay or even prevent complications like liver damage and cirrhosis. There are two types of treatment currently available: anti-viral medications like lamivudine, adefovir, telbivudine, entecavir, and Tenofovir Disoproxil Fumarate (TDF), or their combinations and interferon which help boost the immune system to fight the infections.This study aims to evaluate the safety and efficacy of combination therapy of TDF and PEG versus standard of care treatment with either TDF or PEG for 48 weeks alone.Eligible participants will be randomly assigned into one of four treatment arms: A) 180 participants will be treated with tenofovir (TDF) and interferon (PEG) for 48 weeks B) 180 participants will be treated with tenofovir (TDF) and interferon (PEG) for 16 weeks followed by TDF alone for another 32 weeks (in total 48 weeks treatment)C) 180 participants will be treated with tenofovir (TDF) alone for 120 weeks D) 180 participants will be treated with interferon (PEG) alone for 48 weeks After completing 48 weeks treatment, the participants in Arms A, B and D will be followed for additional 24 weeks. Approximately 720 patients will be invited to participate in this study at up to 150 centers in Europe, North America and Asia.
REC name
London - City & East Research Ethics Committee
REC reference
11/LO/0456
Date of REC Opinion
25 Jul 2011
REC opinion
Further Information Favourable Opinion