Clinical trialNCT01369212CompletedPhase 3Interventional

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

SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Enrollment201Hepatitis B

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Anna Lok, MD
University of Michigan
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗
Averell Sherker, MD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Chair
clinicaltrials.gov ↗
Edward Doo, MD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

21 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

University of Toronto-Toronto Western Hospital
Toronto, Ontario, Canada

United States

Cedars Sinai Medical Center
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
California Pacific Medical Center
San Francisco, California, United States
University of California San Francisco
San Francisco, California, United States
Queen'S Medical Center
Honolulu, Hawaii, United States
Nih Clinical Center
Bethesda, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
University of Minnesota
Plymouth, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Saint Louis University
St Louis, Missouri, United States
Washington University
St Louis, Missouri, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Baylor University Medical Center
Dallas, Texas, United States
University of Texas Southwestern
Dallas, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Peginterferon-alfa 2a and tenofovirTenofovir

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Nov 2012
Primary completion: 8 Mar 2021
Completion: 8 Mar 2021
Last update posted: 28 Apr 2023
Registered enrollment: 201
Registry id: NCT01369212

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.