Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (Peg-IFN) Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis B
Public ClinicalTrials.gov record NCT01277601. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01277601
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 751 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2011 (Type not available)
- Primary completion
- Aug 2014 (Actual)
- Completion
- Jul 2015 (Actual)
- Last update posted
- Aug 26, 2016
2011 – 2015
United States locations
- U.S. sites
- 26
- U.S. states
- 13
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Asian Pacific Liver Center | Los Angeles | California | — | — |
| Stanford University Medical Center | Palo Alto | California | — | — |
| Research and Education Inc | San Diego | California | — | — |
| San Jose Gastroenterology | San Jose | California | — | — |
| Avail Clinical Research, LLC | DeLand | Florida | — | — |
| Centre for Advanced Gastroenterology | Maitland | Florida | — | — |
| University of Miami / Jackson Memorial Medical Center | Miami | Florida | — | — |
| University of Chicago | Chicago | Illinois | — | — |
| LSU Gastroenterology/Center for Digestive Diseases | New Orleans | Louisiana | — | — |
| Tulane University Hospital and Clinic | New Orleans | Louisiana | — | — |
| Digestive Disease Associates | Baltimore | Maryland | — | — |
| Tufts Medical Center | Boston | Massachusetts | — | — |
| Henry Ford Hospital | Detroit | Michigan | — | — |
| ID Care, Inc. | Hillsborough | New Jersey | — | — |
| Medical Procare, PLLC | Flushing | New York | — | — |
| North Shore University Hospital | Great Neck | New York | — | — |
| Beth Israel Medical Center | New York | New York | — | — |
| New York Univ. Medical Center | New York | New York | — | — |
| Weill Cornell Medical College of Cornell University | New York | New York | — | — |
| Private Practice | Philadelphia | Pennsylvania | — | — |
| Advanced Liver Therapies at St. Luke's Episcopal Hospital | Houston | Texas | — | — |
| Kelsey Research Foundation | Houston | Texas | — | — |
| Liver Associates of Texas, | Houston | Texas | — | — |
| University of Utah | Salt Lake City | Utah | — | — |
| Liver Institute of Virginia, Bon Secours Health System | Richmond | Virginia | — | — |
| McGuire Research Institute | Richmond | Virginia | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 145 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01277601, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 26, 2016 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01277601 live on ClinicalTrials.gov.