Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (Peg-IFN) Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis B

July 15, 2016 updated by: Gilead Sciences

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

751

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Fremantle, Australia
        • Fremantle Hospital
      • Nedlands, Australia
        • Sir Charles Gairdner Hospital
      • Perth, Australia
        • Royal Perth Hospital
    • New South Wales
      • Camperdown, New South Wales, Australia
        • Royal Prince Alfred Hospital
      • Concord, New South Wales, Australia
        • Concord Repatriation General Hospital
      • Kogarah, New South Wales, Australia
        • Saint George's Hospital
      • Liverpool, New South Wales, Australia
        • Liverpool Hospital,Gastroenterology Department
      • Westmead, New South Wales, Australia
        • Westmead Hospital
    • Queensland
      • Herston, Queensland, Australia
        • Royal Brisbane & Women's Hospital
      • Woolloongabba, Queensland, Australia
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia
        • Flinders Medical Center
      • Adelaide SA, South Australia, Australia
        • Royal Adelaide Hospital
    • Victoria
      • Clayton, Victoria, Australia
        • Monash Medical Centre
      • Fitzroy, Victoria, Australia
        • Saint Vincents Hospital
      • Footscray, Victoria, Australia
        • Western Hospital
      • Heidelberg, Victoria, Australia
        • Austin Health
      • Melbourne, Victoria, Australia
        • Alfred Hospital
      • Melbourne, Victoria, Australia
        • Box Hill Hospital
      • Parkville, Victoria, Australia
        • Royal Melbourne Hospital
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Heritage Med Research Clinic, Univ of Calgary
      • Zeidler Ledcore Centre, Alberta, Canada
        • University of Alberta, Zeidler Ledcore Centre
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Gordon & Leslie Diamond Health Care Centre
      • Vancouver, British Columbia, Canada
        • Gastrointestional Research Institute
      • Vancouver, British Columbia, Canada
        • Liver and Intestinal Research Centre
    • Ontario
      • Ottawa, Ontario, Canada
        • The Ottawa Hospital,Division of Infectious Diseases
      • Toronto, Ontario, Canada
        • Toronto General Hospital
      • Toronto, Ontario, Canada
        • Toronto Liver Centre
  • France
      • Paris, France
        • Hopital Tenon
      • Rennes Cedex 9, France
        • Centre Hospitalier Universitaire de Rennes
      • Rouen, France
        • Hopital Charles Nicolle
      • Strasbourg, France
        • Centre Hospitalier Regional et Universitaire de Strasbourg, Hopital Civil
      • Toulouse, France
        • Centre Hospitalier Universitaire Purpan
      • Villejuif Cedex, France
        • Hopital Paul Brousse
    • Cedex
      • Clichy, Cedex, France
        • Hôpital Beaujon, Service Hepatologie- Centre Pierre Abrami
      • Lyon, Cedex, France
        • Hôpital de la Croix Rousse
  • Germany
      • Berlin, Germany
        • Charite Berlin
      • Essen, Germany
        • Universitätsklinikum Essen - klinikum für Gastroenterolgie und Hepatologie,
      • Frankfurt, Germany
        • Johann-Wolfgang-Goethe Universitat,
      • Hamburg, Germany
        • Asklepios Westklinikum
      • Hannover, Germany
        • Medizinische Hochschule Hannover,Hastroenterologie und Hepatologie
      • Köln, Germany
        • Universitätsklinik Köln
      • Leipzig, Germany
        • Universitätsklinikum Leipzig
    • Rheinland-pfalz
      • Mainz, Rheinland-pfalz, Germany
        • Johannes Gutenberg-Universitat Mainz,
  • Greece
      • Attica, Greece
        • Ippokratio Hospital Athens
      • Patra, Greece
        • General University Hospital of Patras
      • Thessaloniki, Greece
        • Hippokration General Hospital of Thessaloniki
    • Attica
      • Thessaloniki, Attica, Greece
        • Ippokratio Hospital Salonica
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Kowloon, Hong Kong
        • Princess Margaret Hospital
      • Shatin, Hong Kong
        • Prince of Wales Hospital
      • Tai Po, Hong Kong
        • Alice Ho Miu Ling Nethersole Hospital
  • India
      • New Delhi, India
        • Institute of Liver and Biliary Sciences
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India
        • Global Hospital, Lakdi Ka Pul
    • Assam
      • Guwahati, Assam, India
        • Institute of digestive and liver disease, Dispur Hospital Ganeshguri
    • Gujarat
      • Ahmedabad, Gujarat, India
        • Vedanta Institute Of Medical Sciences
      • Surat, Gujarat, India
        • Liver Clinic
    • Karnataka
      • Bangalore, Karnataka, India
        • Manipal Hospitals
    • Maharashtra
      • Mumbai, Maharashtra, India
        • Department of Hepatology, Institute of Liver Diseases, HPB Surgery and Transplant, Global Hospital
      • Mumbai, Maharashtra, India
        • Seth GS Medical College and KEM Hospital, Acharya Donde Marg,Parel
      • Nagpur, Maharashtra, India
        • Midas Institute of Gastroenterology
      • Sangli, Maharashtra, India
        • Dharamasi Hospital,Chandni Chowk, South Shivajinagar,
    • New Delhi
      • Delhi, New Delhi, India
        • All India Institute of Medical Sciences, Ansari Nagar
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India
        • VGM Hospital
    • West Bengal
      • Kolkata, West Bengal, India
        • Institute of Post Graduate Medical Education And Research
  • Italy
      • Milano, Italy
        • Ospedale San Raffaele
      • Milano, Italy
        • Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico
      • Napoli, Italy
        • Seconda Università degli Studi di Napoli
      • Parma, Italy
        • Azienda Ospedaliera di Parma,Department of Infectious Diseases and hepatology
      • Roma, Italy
        • Fondazione PTV - Policlinico Tor Vergata
      • Rome, Italy
        • Policlinico Umberto I
      • Torino, Italy
        • University of Milan,Azienda Ospedaliera San Giovanni, Battista di Torino,Dipartimento di Gastroenterologia
    • Cagliari
      • Monserrato, Cagliari, Italy
        • Azienda Ospedaliero-Universitaria di Cagliari
  • Korea, Republic of
      • Busan, Korea, Republic of
        • Inje University Busan Paik Hospital
      • Goyang, Gyeonggi-Do, Korea, Republic of
        • Inje University Ilsan Paik Hospital
      • Kwangjin-gu, Seoul, Korea, Republic of
        • Digestive Disease Cntr, Konkuk Univ Hosp
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Konkuk University Medical Center
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of
        • Seoul Saint Mary's Hospital
    • Chungcheon
      • Cheonan, Chungcheon, Korea, Republic of
        • SoonChunHyang University Hospital Cheonan
    • Gangwon-do
      • Wonju, Gangwon-do, Korea, Republic of
        • Yonsei Unversity Wonju College of Medicine Wonju Christian Hospital
    • Gyeonggi-d
      • Ansan-si, Gyeonggi-d, Korea, Republic of
        • Korea University Ansan Hospital
      • Bucheon, Gyeonggi-d, Korea, Republic of
        • Bucheon St. Mary's Hospital
      • Seoul, Gyeonggi-d, Korea, Republic of
        • Korea University Guro Hospital
      • Sungnam, Gyeonggi-d, Korea, Republic of
        • CHA Bundang Medical Center, CHA University
    • Gyeongsang
      • Busan, Gyeongsang, Korea, Republic of
        • Pusan National University Hospital
      • Daegu, Gyeongsang, Korea, Republic of
        • Kyungpook National University Hospital
      • Yangsan, Gyeongsang, Korea, Republic of
        • Pusan National University Yangsan Hospital
  • Netherlands
      • Amsterdam, Netherlands
        • Academisch Medisch Centrum
      • Amsterdam, Netherlands
        • Vrije Universiteit Medisch Centrum
      • Rotterdam, Netherlands
        • Erasmus Medisch Centrum
  • Poland
      • Bialystok, Poland
        • Wojewodzki Szpital Specjalistyczny Kazimierza Dluskeigo w Bialymstoku
      • Bydgoszcz, Poland
        • Wojewódzki Szpital Obserwacyjno Zakazny im. Tadeusza Browicza
      • Krakow, Poland
        • Szpital Uniwersytecki w Krakowie
      • Lodz, Poland
        • Wojewódzki Specjalistyczny Szpital im. Dr Wladyslawa Bieganskiego w Lodzi
      • Warszawa, Poland
        • SP ZOZ Wojewódzki Szpital Zakazny
    • Lodzkie
      • Lodz, Lodzkie, Poland
        • Wojewódzki Specjalistyczny Szpital im. Dr Wladyslawa Bieganskiego w Lodzi
    • Lubelskie
      • Lublin, Lubelskie, Poland
        • Samodzielny Publiczny Szpital Kliniczny 1,Klinika Chorób Zakaznych,ulica Staszica 16
    • Slaskie
      • Chorzów, Slaskie, Poland
        • Szpital Specjalistyczny w Chorzowie
  • Portugal
      • Lisboa, Portugal
        • Hospital De Santa Maria
      • Lisboa, Portugal
        • Hospital de Egas Moniz
      • Porto, Portugal
        • Centro Hospitalar do Porto
      • Porto, Portugal
        • Hospital Sao Joao
  • Romania
      • Brasov, Romania
        • Neomed Research
      • Bucharest, Romania
        • Spitalul Clinic de Boli Infecțioase și tropicale "Dr. Victor Babeș"
      • Bucharest, Romania
        • Institutul National de Boli Infectioase Prof.Dr. Matei Bals
      • Bucharest, Romania
        • Institutul National De Boli Infectioase "Prof. Dr. Matei Bals"
      • Bucuresti, Romania
        • Spitalul Clinic Colentina
      • Sibiu, Romania
        • Spitalul Clinic Judetean de Urgenta Sibiu
      • Timisoara, Romania
        • Cabinet Particular Policlinic Algomed SRL-Gastroenterologie
  • Singapore
      • Singapore, Singapore
        • Singapore General Hospital
      • Singapore, Singapore
        • Tan Tock Seng Hospital
      • Singapore, Singapore
        • Changi General Hospital
      • Singapore, Singapore
        • National University Hospital Singapore
  • Spain
      • Barcelona, Spain
        • Hospital General Universitari Vall d' Hebron
      • Madrid, Spain
        • Hospital Universitario de la Princesa
      • Madrid, Spain
        • Hospital Carlos III
      • Malaga, Spain
        • Hospital Virgen de la Victoria
      • Sevilla, Spain
        • Hospital Universitario Virgen del Rocio
      • Vigo, Pontevedra, Spain
        • Hospital Meixoeiro
  • Taiwan
      • Changhua, Taiwan
        • Changhua Christain Hospital
      • Chia-Yi, Taiwan
        • Chiayi Christian Hosp
      • Hualien, Taiwan
        • Buddhist Tzu Chi General Hospital
      • Kaohsiung, Taiwan
        • Chang Gung Memorial Hospital
      • Kaosiung, Taiwan
        • Kaohsiung Medical University Hospital
      • Keelung Town/KEELUNG CITY, Taiwan
        • Chang Gung Medical Foundation-Keelung
      • Taichung, Taiwan
        • China Medical University Hospital
      • Taichung, Taiwan
        • Chung Shan Medical University Hospital
      • Taichung, Taiwan
        • Taichung Veterans Genl Hosp
      • Tainan, Taiwan
        • National Cheng Kung University Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Cathay General Hospital
    • Banciao Dist
      • New Taipei City, Banciao Dist, Taiwan
        • Far-Eastern Memorial Hosp
    • Taoyuan
      • Tao-Yuan, Taoyuan, Taiwan
        • Chang Gung Medical Foundation.LinKou Branch
  • Turkey
      • Ankara, Turkey
        • Hacettepe Universitesi Tip Fakultesi
      • Ankara, Turkey
        • Ankara Universitesi Tip Fakultesi
      • Gaziantep, Turkey
        • Gaziantep Üniversitesi Tip Fakültesi, Sahinbey Arastirma ve Uygulama Hastanesi
      • Istanbul, Turkey
        • Istanbul Universitesi Istanbul Tip Fakultesi
      • Mersin, Turkey
        • Mersin Üniversitesi Tip Fakültesi, Saglik Arastirma ve Uygulama Hastanesi
  • United Kingdom
      • Birmingham, WSTMID, United Kingdom
        • The Queen Elizabeth Hospital
      • Hampstead,London, United Kingdom
        • Royal Free Hospital
      • London, United Kingdom
        • King's College Hospital
      • London, United Kingdom
        • Barts and The London NHS Trust
  • United States
    • California
      • Los Angeles, California, United States
        • Asian Pacific Liver Center
      • Palo Alto, California, United States
        • Stanford University Medical Center
      • San Diego, California, United States
        • Research and Education Inc
      • San Jose, California, United States
        • San Jose Gastroenterology
    • Florida
      • Deland, Florida, United States
        • Avail Clinical Research, LLC
      • Maitland, Florida, United States
        • Centre for Advanced Gastroenterology
      • Miami, Florida, United States
        • University of Miami / Jackson Memorial Medical Center
    • Illinois
      • Chicago, Illinois, United States
        • University of Chicago
    • Louisiana
      • New Orleans, Louisiana, United States
        • LSU Gastroenterology/Center for Digestive Diseases
      • New Orleans, Louisiana, United States
        • Tulane University Hospital and Clinic
    • Maryland
      • Baltimore, Maryland, United States
        • Digestive Disease Associates
    • Massachusetts
      • Boston, Massachusetts, United States
        • Tufts Medical Center
    • Michigan
      • Detroit, Michigan, United States
        • Henry Ford Hospital
    • New Jersey
      • Hillsborough, New Jersey, United States
        • ID Care, Inc.
    • New York
      • Flushing, New York, United States
        • Medical Procare, PLLC
      • Great Neck, New York, United States
        • North Shore University Hospital
      • New York, New York, United States
        • Beth Israel Medical Center
      • New York, New York, United States
        • New York Univ. Medical Center
      • New York, New York, United States
        • Weill Cornell Medical College of Cornell University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Private Practice
    • Texas
      • Houston, Texas, United States
        • Advanced Liver Therapies at St. Luke's Episcopal Hospital
      • Houston, Texas, United States
        • Kelsey Research Foundation
      • Houston, Texas, United States
        • Liver Associates of Texas,
    • Utah
      • Salt Lake City, Utah, United States
        • University of Utah
    • Virginia
      • Richmond, Virginia, United States
        • McGuire Research Institute
      • Richmond, Virginia, United States
        • Liver Institute of Virginia, Bon Secours Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults (age 18-75) with chronic HBV (positive for serum hepatitis B surface antigen (HBsAg) or HBV DNA for at least 6 months) prior to baseline
  • Anti-HBV treatment-naive adults; adults who have taken oral anti-HBV nucleoside therapy with the last dose ≥ 24 weeks prior to screening are also eligible.
  • Positive or negative for hepatitis B e antigen (HBeAg)
  • HBV DNA ≥ 20,000 IU/ml (HBeAg-positive participants) and ≥ 2,000 IU/ml (HBeAg-negative participants)
  • Alanine aminotransferase (ALT) > 54 U/L and ≤ 400 U/L for men and > 36 U/L and ≤ 300 U/L for women
  • Creatinine clearance ≥ 70 mL/min
  • Negative serum pregnancy test for females of childbearing potential
  • Sexually active females of childbearing potential must agree to use a protocol-recommended method of contraception throughout the study and for 30 days following the last dose of study medication
  • Lactating females must agree to discontinue nursing before initiation of study investigational medicinal product

Exclusion Criteria:

  • Known bridging fibrosis or cirrhosis and/or decompensated liver disease
  • Evidence of hepatocellular carcinoma
  • Significant kidney, heart, lung, neurological, autoimmune disease, or bone disease (eg, osteomalacia,chronic osteomyelitis, osteogenesis imperfecta, osteochondrosis, multiple bone fractures)
  • Absolute neutrophil count < 1,500/mm^3, platelet < 100,000/mm^3, hemoglobin < 10 g/dL (female) or < 11 g/dL (male)
  • History of severe depression or severe psychiatric disease
  • Thyroid dysfunction
  • Coinfection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV)
  • Pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TDF+Peg-IFN 48 Weeks
TDF plus Peg-IFN for 48 weeks
Drug: TDF
TDF 300 mg tablets administered orally once daily
Other Names:
  • Viread®
Drug: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Other Names:
  • Pegasys®
Experimental: TDF 48 Weeks + Peg-IFN 16 Weeks
TDF plus Peg-IFN for 16 weeks, followed by TDF alone for an additional 32 weeks
Drug: TDF
TDF 300 mg tablets administered orally once daily
Other Names:
  • Viread®
Drug: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Other Names:
  • Pegasys®
Active Comparator: TDF 120 Weeks
TDF monotherapy for 120 weeks
Drug: TDF
TDF 300 mg tablets administered orally once daily
Other Names:
  • Viread®
Active Comparator: Peg-IFN 48 Weeks
Peg-IFN monotherapy for 48 weeks
Drug: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Other Names:
  • Pegasys®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With 48 Weeks of TDF Plus Peg-IFN Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone
Time Frame: Baseline; Week 72

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.
Baseline; Week 72

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With TDF (48 Weeks) Plus Peg-IFN (16 Weeks) Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone
Time Frame: Baseline; Week 72

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.
Baseline; Week 72
Percentage of Participants With HBsAg Loss at Weeks 96 and 120
Time Frame: Baseline; Weeks 96 and 120

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 96 comprised study Week 90 through Week 102, so results up to Week 102 are included in this analysis. The analysis visit window for Week 120 comprised study Week 114 through Week 126, so results up to Week 126 are included in this analysis.
Baseline; Weeks 96 and 120
Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120
Time Frame: Baseline; Weeks 72, 96, and 120

HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. 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. The analysis visit window for Week 96 comprised Week 90 through Week 102, so results up to Week 102 are included in this analysis. The analysis visit window for Week 120 comprised Week 114 through Week 120.
Baseline; Weeks 72, 96, and 120
Percentage of Participants With HBeAg Loss and Seroconversion at Week 72
Time Frame: Baseline; Week 72

Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit.

For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 72, and in the "Retreated" column for participants who did enter the retreatment phase by Week 72.
Baseline; Week 72
Percentage of Participants With HBeAg Loss and Seroconversion at Week 96
Time Frame: Baseline; Week 96

Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit.

For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 96, and in the "Retreated" column for participants who did enter the retreatment phase by Week 96.
Baseline; Week 96
Percentage of Participants With HBeAg Loss and Seroconversion at Week 120
Time Frame: Baseline; Week 120

Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit.

For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 120, and in the "Retreated" column for participants who did enter the retreatment phase by Week 120.
Baseline; Week 120
Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 72
Time Frame: Week 72
For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 72, and in the "Retreated" column for participants who did enter the retreatment phase by Week 72.
Week 72
Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 96
Time Frame: Week 96
For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 96, and in the "Retreated" column for participants who did enter the retreatment phase by Week 96.
Week 96
Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 120
Time Frame: Week 120
For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 120, and in the "Retreated" column for participants who did enter the retreatment phase by Week 120.
Week 120
Percentage of Participants With Normal ALT at Week 72
Time Frame: Week 72

Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT).

For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 72, and in the "Retreated" column for participants who did enter the retreatment phase by Week 72.
Week 72
Percentage of Participants With Normal ALT at Week 96
Time Frame: Week 96

Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT).

For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 96, and in the "Retreated" column for participants who did enter the retreatment phase by Week 96.
Week 96
Percentage of Participants With Normal ALT at Week 120
Time Frame: Week 120

Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT).

For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 120, and in the "Retreated" column for participants who did enter the retreatment phase by Week 120.
Week 120
Percentage of Participants Who Required Retreatment
Time Frame: Up to 120 weeks
Participants in the TDF 120 week group were not eligible to enter the retreatment phase and are not presented.
Up to 120 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Investigators

  • Study Director: Belinda Jump, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

January 13, 2011

First Submitted That Met QC Criteria

January 14, 2011

First Posted (Estimate)

January 17, 2011

Study Record Updates

Last Update Posted (Estimate)

August 26, 2016

Last Update Submitted That Met QC Criteria

July 15, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-174-0149
  • 2010-024586-45 (EudraCT Number)

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