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NCT01277601 · ClinicalTrials.gov registry record · Phase 4
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 study of Chronic Hepatitis B, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 4
- Development phase
- 751
- Enrollment target
- 20
- Study locations
NCT01277601: Completed Phase 4 study of Chronic Hepatitis B, sponsored by Gilead Sciences.
NCT01277601 is a Phase 4 study of Chronic Hepatitis B that has completed, run by Gilead Sciences. The registered enrollment target is 751 participants, above the 240-participant average among 14 other Chronic Hepatitis B trials with a reported enrollment target (213% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01277601, a Phase 4 study of Chronic Hepatitis B, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 751 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate. The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis.
Conditions Studied
Interventions
- DRUG TDF
- DRUG Peg-IFN
Study Locations (20)
New York
- Medical Procare, PLLC - Flushing
- North Shore University Hospital - Great Neck
- Beth Israel Medical Center - New York
- New York Univ. Medical Center - New York
- Weill Cornell Medical College of Cornell University - New York
California
- Asian Pacific Liver Center - Los Angeles
- Stanford University Medical Center - Palo Alto
- Research and Education Inc - San Diego
- San Jose Gastroenterology - San Jose
Florida
- Avail Clinical Research, LLC - DeLand
- Centre for Advanced Gastroenterology - Maitland
- University of Miami / Jackson Memorial Medical Center - Miami
Louisiana
- LSU Gastroenterology/Center for Digestive Diseases - New Orleans
- Tulane University Hospital and Clinic - New Orleans
Illinois
- University of Chicago - Chicago
Maryland
- Digestive Disease Associates - Baltimore
Massachusetts
- Tufts Medical Center - Boston
Michigan
- Henry Ford Hospital - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 751 participants |
| Start Date | 2011-04 |
| Est. Completion | 2015-07 |
| Phase | Phase 4 |
What the finished NCT01277601 record still lists
NCT01277601 is an interventional study that assigns participants to a tested intervention. The registered 751 participants enrollment target is mid-sized for trials with a published cap, above the 240-participant average among 14 other Chronic Hepatitis B trials with a reported enrollment target (213% higher).
The record links to 1 condition, with Chronic Hepatitis B appearing as the primary indexed condition, and to 2 interventions - of which TDF is the first listed.
NCT01277601 names 20 study sites across 10 states, led by New York, California, Florida.
Frequently Asked Questions
What is clinical trial NCT01277601 about?
NCT01277601 is a clinical study titled "Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (Peg-IFN) Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis B". 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...
What is the current status of trial NCT01277601?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 751 participants. The study started on 2011-04. Estimated completion is 2015-07.
What conditions does trial NCT01277601 study?
This clinical trial studies the following conditions: Chronic Hepatitis B.
What interventions are being tested in trial NCT01277601?
The interventions under investigation include: TDF (DRUG), Peg-IFN (DRUG).
Who is sponsoring clinical trial NCT01277601?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01277601 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Hepatitis B
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01277601's enrollment target sits among peer trials
751 3rd of 14 higher than 12 of 14 other Chronic Hepatitis B trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Hepatitis B trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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