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Completed Phase 3 Interventional Results available

Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B

ClinicalTrials.gov ID: NCT01369212

Public ClinicalTrials.gov record NCT01369212. 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.

ClinicalTrials.gov public records Last synced Nov 7, 2026, 5:53 PM EST

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Official title

Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in HBeAg-positive and HBeAg-negative Chronic Hepatitis B

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This clinical trial compares the efficacy of peginterferon plus tenofovir for 24 weeks followed by monotherapy with tenofovir for a further 3.5 years to the efficacy of tenofovir alone given for 4 years in patients with chronic hepatitis B. The primary measure of outcome will be HBsAg loss in serum at 48 weeks after stopping all antiviral therapy (sustained off-treatment response).

Study identification

NCT ID
NCT01369212
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
201 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
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
Nov 2012 (Type not available)
Primary completion
Mar 8, 2021 (Actual)
Completion
Mar 8, 2021 (Actual)
Last update posted
Apr 28, 2023

2012 – 2021

United States locations

U.S. sites
20
U.S. states
11
U.S. cities
14
Facility City State ZIP Site status
Cedars Sinai Medical Center Los Angeles California 90048 —
University of California Los Angeles Los Angeles California 90095 —
California Pacific Medical Center San Francisco California 94115 —
University of California San Francisco San Francisco California 94143 —
Queen's Medical Center Honolulu Hawaii 96813 —
NIH Clinical Center Bethesda Maryland 20892 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 —
University of Michigan Health System Ann Arbor Michigan 48109 —
University of Minnesota Plymouth Minnesota 55446 —
Mayo Clinic Rochester Minnesota 55905 —
Saint Louis University St Louis Missouri 63104 —
Washington University St Louis Missouri 63110 —
University of North Carolina Chapel Hill North Carolina 27599 —
Duke University Medical Center Durham North Carolina 27710 —
Baylor University Medical Center Dallas Texas 75246 —
University of Texas Southwestern Dallas Texas 75390 —
Virginia Commonwealth University Richmond Virginia 23498 —
Virginia Mason Medical Center Seattle Washington 98101 —
University of Washington Medical Center Seattle Washington 98105 —

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 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01369212, 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 Apr 28, 2023 · Synced Nov 7, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01369212 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →