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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 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.

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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.

Conditions Studied

Chronic Hepatitis B

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

FieldValue
Enrollment Target 751 participants
Start Date 2011-04
Est. Completion 2015-07
Phase Phase 4

Sponsor

Gilead Sciences

504 total trials

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What the Registry Record Tells You About NCT01277601

The ClinicalTrials.gov registry entry for NCT01277601 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 751 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 240-participant average among 14 other Chronic Hepatitis B trials with a reported enrollment target (213% higher). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.