NCT01277601

Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (Peg-IFN) Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis B

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 751 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy of tenofovir disoproxil fumarate (TDF) plus peginterferon α-2a (Peg-IFN) combination therapy for 48 weeks versus standard of care TDF monotherapy or Peg-IFN monotherapy for 48 weeks in non-cirrhotic adults with chronic hepatitis B virus (HBV) as determined by loss of hepatitis B surface antigen (HBsAg). The study will consist of 2 phases for participants in the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups. Following an initial 48 weeks of treatment, participants in these groups will be monitored for 24 weeks for signs of worsening HBV, and those meeting TDF retreatment and flare management criteria will be eligible to receive TDF monotherapy during a retreatment phase, up to Week 120.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	TDF	TDF 300 mg tablets administered orally once daily
DRUG	Peg-IFN	Peg-IFN 180 µg administered via subcutaneous injection once weekly

Timeline

• Start date: 2011-04-01
• Primary completion: 2014-08-01
• Completion: 2015-07-01
• First posted: 2011-01-17
• Last updated: 2016-08-26
• Results posted: 2015-09-09

Locations

171 sites across 19 countries: United States, Australia, Canada, France, Germany, Greece, Hong Kong, India, Italy, Netherlands, Poland, Portugal, Romania, Singapore, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom