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AzTrials

Chronic Hepatitis BPhase 4NCT01277601

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 testing TDF and Peg-IFN in people with Chronic Hepatitis B, run by Gilead Sciences at 171 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Hepatitis B
What is being tested?
TDF and Peg-IFN
Could I receive a placebo?
No, everyone receives an active treatment
How many people
751 participants
Where
171 sitesin 19 countries
Study dates
Apr 2011to Jul 2015
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

171 sites in 19 countries.

171 sites in 19 countries

United States26 sites

  • Digestive Disease Associates

    Baltimore, Maryland

  • Tufts Medical Center

    Boston, Massachusetts

  • University of Chicago

    Chicago, Illinois

  • Avail Clinical Research, LLC

    DeLand, Florida

  • Henry Ford Hospital

    Detroit, Michigan

  • Medical Procare, PLLC

    Flushing, New York

  • North Shore University Hospital

    Great Neck, New York

  • ID Care, Inc.

    Hillsborough, New Jersey

  • Advanced Liver Therapies at St. Luke's Episcopal Hospital

    Houston, Texas

  • Kelsey Research Foundation

    Houston, Texas

  • Liver Associates of Texas,

    Houston, Texas

  • Asian Pacific Liver Center

    Los Angeles, California

  • Centre for Advanced Gastroenterology

    Maitland, Florida

  • University of Miami / Jackson Memorial Medical Center

    Miami, Florida

  • LSU Gastroenterology/Center for Digestive Diseases

    New Orleans, Louisiana

  • Tulane University Hospital and Clinic

    New Orleans, Louisiana

  • 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

  • Stanford University Medical Center

    Palo Alto, California

  • Private Practice

    Philadelphia, Pennsylvania

  • Liver Institute of Virginia, Bon Secours Health System

    Richmond, Virginia

  • McGuire Research Institute

    Richmond, Virginia

  • University of Utah

    Salt Lake City, Utah

  • Research and Education Inc

    San Diego, California

  • San Jose Gastroenterology

    San Jose, California

Other trials in United States

Australia19 sites

  • Flinders Medical Center

    Adelaide, South Australia

  • Royal Adelaide Hospital

    Adelaide SA, South Australia

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales

  • Monash Medical Centre

    Clayton, Victoria

  • Concord Repatriation General Hospital

    Concord, New South Wales

  • Saint Vincents Hospital

    Fitzroy, Victoria

  • Western Hospital

    Footscray, Victoria

  • Fremantle Hospital

    Fremantle

  • Austin Health

    Heidelberg, Victoria

  • Royal Brisbane & Women's Hospital

    Herston, Queensland

  • Saint George's Hospital

    Kogarah, New South Wales

  • Liverpool Hospital,Gastroenterology Department

    Liverpool, New South Wales

  • Alfred Hospital

    Melbourne, Victoria

  • Box Hill Hospital

    Melbourne, Victoria

  • Sir Charles Gairdner Hospital

    Nedlands

  • Royal Melbourne Hospital

    Parkville, Victoria

  • Royal Perth Hospital

    Perth

  • Westmead Hospital

    Westmead, New South Wales

  • Princess Alexandra Hospital

    Woolloongabba, Queensland

Other trials in Australia

South Korea18 sites

  • Korea University Ansan Hospital

    Ansan-si, Gyeonggi-d

  • Bucheon St. Mary's Hospital

    Bucheon-si, Gyeonggi-d

  • Pusan National University Hospital

    Busan, Gyeongsang

  • Inje University Busan Paik Hospital

    Busan

  • SoonChunHyang University Hospital Cheonan

    Cheonan, Chungcheon

  • Kyungpook National University Hospital

    Daegu, Gyeongsang

  • Inje University Ilsan Paik Hospital

    Goyang, Gyeonggi-Do

  • Digestive Disease Cntr, Konkuk Univ Hosp

    Kwangjin-gu, Seoul

  • Korea University Guro Hospital

    Seoul, Gyeonggi-d

  • Asan Medical Center

    Seoul

  • Gangnam Severance Hospital

    Seoul

  • Konkuk University Medical Center

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • Seoul Saint Mary's Hospital

    Seoul

  • CHA Bundang Medical Center, CHA University

    Sungnam, Gyeonggi-d

  • Yonsei Unversity Wonju College of Medicine Wonju Christian Hospital

    Wŏnju, Gangwon-do

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsang

Other trials in South Korea

Taiwan14 sites

  • Changhua Christain Hospital

    Changhua

  • Chiayi Christian Hosp

    Chiayi City

  • Buddhist Tzu Chi General Hospital

    Hualien City

  • Chang Gung Memorial Hospital

    Kaohsiung City

  • Kaohsiung Medical University Hospital

    Kaosiung

  • Chang Gung Medical Foundation-Keelung

    Keelung Town/KEELUNG CITY

  • Far-Eastern Memorial Hosp

    New Taipei City, Banciao Dist

  • China Medical University Hospital

    Taichung

  • Chung Shan Medical University Hospital

    Taichung

  • Taichung Veterans Genl Hosp

    Taichung

  • National Cheng Kung University Hospital

    Tainan

  • Cathay General Hospital

    Taipei

  • National Taiwan University Hospital

    Taipei

  • Chang Gung Medical Foundation.LinKou Branch

    Taoyuan, Taoyuan

Other trials in Taiwan

India13 sites

  • Vedanta Institute of Medical Sciences

    Ahmedabad, Gujarat

  • Manipal Hospitals

    Bangalore, Karnataka

  • VGM Hospital

    Coimbatore, Tamil Nadu

  • All India Institute of Medical Sciences, Ansari Nagar

    Delhi, New Delhi

  • Institute of digestive and liver disease, Dispur Hospital Ganeshguri

    Guwahati, Assam

  • Global Hospital, Lakdi Ka Pul

    Hyderabad, Andhra Pradesh

  • Institute of Post Graduate Medical Education And Research

    Kolkata, West Bengal

  • Department of Hepatology, Institute of Liver Diseases, HPB Surgery and Transplant, Global Hospital

    Mumbai, Maharashtra

  • Seth GS Medical College and KEM Hospital, Acharya Donde Marg,Parel

    Mumbai, Maharashtra

  • Midas Institute of Gastroenterology

    Nagpur, Maharashtra

  • Institute of Liver and Biliary Sciences

    New Delhi, New Delhi

  • Dharamasi Hospital,Chandni Chowk, South Shivajinagar,

    Sangli, Maharashtra

  • Liver Clinic

    Surat, Gujarat

Other trials in India

Canada8 sites

  • Heritage Med Research Clinic, Univ of Calgary

    Calgary, Alberta

  • The Ottawa Hospital,Division of Infectious Diseases

    Ottawa, Ontario

  • Toronto General Hospital

    Toronto, Ontario

  • Toronto Liver Centre

    Toronto, Ontario

  • Gastrointestional Research Institute

    Vancouver, British Columbia

  • Gordon & Leslie Diamond Health Care Centre

    Vancouver, British Columbia

  • Liver and Intestinal Research Centre

    Vancouver, British Columbia

  • University of Alberta, Zeidler Ledcore Centre

    Zeidler Ledcore Centre, Alberta

Other trials in Canada

France8 sites

  • Hôpital Beaujon, Service Hepatologie- Centre Pierre Abrami

    Clichy, Cedex

  • Hôpital de la Croix Rousse

    Lyon, Cedex

  • Hopital Tenon

    Paris

  • Centre Hospitalier Universitaire de Rennes

    Rennes

  • Hopital Charles Nicolle

    Rouen

  • Centre Hospitalier Regional et Universitaire de Strasbourg, Hopital Civil

    Strasbourg

  • Centre Hospitalier Universitaire Purpan

    Toulouse

  • Hopital Paul Brousse

    Villejuif

Other trials in France

Germany8 sites

  • Charite Berlin

    Berlin

  • Universitatsklinik Koln

    Cologne

  • Universitätsklinikum Essen - klinikum für Gastroenterolgie und Hepatologie,

    Essen

  • Johann-Wolfgang-Goethe Universitat,

    Frankfurt

  • Asklepios Westklinikum

    Hamburg

  • Medizinische Hochschule Hannover,Hastroenterologie und Hepatologie

    Hanover

  • Universitatsklinikum Leipzig

    Leipzig

  • Johannes Gutenberg-Universitat Mainz,

    Mainz, Rhineland-Palatinate

Other trials in Germany

Italy8 sites

  • Fondazione IRCCS Ca Granda - Ospedale Maggiore Policlinico

    Milan

  • Ospedale San Raffaele

    Milan

  • Azienda Ospedaliero-Universitaria di Cagliari

    Monserrato, Cagliari

  • Seconda Universita degli Studi di Napoli

    Naples

  • Azienda Ospedaliera di Parma,Department of Infectious Diseases and hepatology

    Parma

  • Fondazione PTV - Policlinico Tor Vergata

    Roma

  • Policlinico Umberto I

    Rome

  • University of Milan,Azienda Ospedaliera San Giovanni, Battista di Torino,Dipartimento di Gastroenterologia

    Torino

Other trials in Italy

Poland8 sites

  • Wojewodzki Szpital Specjalistyczny Kazimierza Dluskeigo w Bialymstoku

    Bialystok

  • Wojewódzki Szpital Obserwacyjno Zakazny im. Tadeusza Browicza

    Bydgoszcz

  • Szpital Specjalistyczny w Chorzowie

    Chorzów, Silesian Voivodeship

  • Szpital Uniwersytecki w Krakowie

    Krakow

  • Wojewódzki Specjalistyczny Szpital im. Dr Wladyslawa Bieganskiego w Lodzi

    Lodz

  • Wojewódzki Specjalistyczny Szpital im. Dr Wladyslawa Bieganskiego w Lodzi

    Lodz, Łódź Voivodeship

  • Samodzielny Publiczny Szpital Kliniczny 1,Klinika Chorób Zakaznych,ulica Staszica 16

    Lublin, Lublin Voivodeship

  • SP ZOZ Wojewodzki Szpital Zakazny

    Warsaw

Other trials in Poland

Romania7 sites

  • Neomed Research

    Brasov

  • Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"

    Bucharest

  • Institutul National de Boli Infectioase Prof.Dr. Matei Bals

    Bucharest

  • Spitalul Clinic Colentina

    Bucharest

  • Spitalul Clinic de Boli Infectioase si Tropicale "Dr. Victor Babes"

    Bucharest

  • Spitalul Clinic Judetean de Urgenta Sibiu

    Sibiu

  • Cabinet Particular Policlinic Algomed SRL-Gastroenterologie

    Timișoara

Other trials in Romania

Spain6 sites

  • Hospital General Universitari Vall d' Hebron

    Barcelona

  • Hospital Universitario de La Princesa

    Madrid, Madrid

  • Hospital Carlos III

    Madrid

  • Hospital Virgen de la Victoria

    Málaga

  • Hospital Universitario Virgen del Rocio

    Seville

  • Hospital Meixoeiro

    Vigo, Pontevedra

Other trials in Spain

Turkey (Türkiye)5 sites

  • Ankara Üniversitesi Tip Fakültesi

    Ankara, Ankara

  • Hacettepe Üniversitesi Tip Fakültesi

    Ankara, Ankara

  • Gaziantep Üniversitesi Tip Fakültesi, Sahinbey Arastirma ve Uygulama Hastanesi

    Gaziantep

  • Istanbul Universitesi Istanbul Tip Fakultesi

    Istanbul

  • Mersin Üniversitesi Tip Fakültesi, Saglik Arastirma ve Uygulama Hastanesi

    Mersin

Other trials in Turkey (Türkiye)

Greece4 sites

  • Ippokratio Hospital Athens

    Attica

  • General University Hospital of Patras

    Pátrai

  • Ippokratio Hospital Salonica

    Thessaloniki, Attica

  • Hippokration General Hospital of Thessaloniki

    Thessaloniki

Other trials in Greece

Hong Kong4 sites

  • Queen Mary Hospital

    Hong Kong

  • Princess Margaret Hospital

    Kowloon

  • Prince of Wales Hospital

    Shatin

  • Alice Ho Miu Ling Nethersole Hospital

    Tai Po

Other trials in Hong Kong

Portugal4 sites

  • Hospital de Egas Moniz

    Lisbon

  • Hospital de Santa Maria

    Lisbon

  • Centro Hospitalar do Porto

    Porto

  • Hospital São João

    Porto

Other trials in Portugal

Singapore4 sites

  • Changi General Hospital

    Singapore

  • National University Hospital Singapore

    Singapore

  • Singapore General Hospital

    Singapore

  • Tan Tock Seng Hospital

    Singapore

Other trials in Singapore

United Kingdom4 sites

  • The Queen Elizabeth Hospital

    Birmingham, Wstmid

  • Royal Free Hospital

    Hampstead,London

  • Barts and The London NHS Trust

    London

  • King's College Hospital

    London

Other trials in United Kingdom

Netherlands3 sites

  • Academisch Medisch Centrum

    Amsterdam

  • Vrije Universiteit Medisch Centrum

    Amsterdam

  • Erasmus Medisch Centrum

    Rotterdam

Other trials in Netherlands

About this study

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)

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.

Being tested
TDF, Peg-IFN
Keywords
Chronic Hepatitis B, Hep B, Non cirrhotic, Tenofovir disoproxil fumarate (TDF), Peginterferon α-2a (Peg-IFN)
Medical subject headings
Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TDFDrug

    Also called Viread®

    TDF 300 mg tablets administered orally once daily

  • Peg-IFNDrug

    Also called Pegasys®

    Peg-IFN 180 µg administered via subcutaneous injection once weekly

Study groups in NCT01277601
Study groupRoleWhat they receive
TDF+Peg-IFN 48 WeeksExperimentalTDF plus Peg-IFN for 48 weeks
Receives: Drug: TDF; Drug: Peg-IFN
TDF 48 Weeks + Peg-IFN 16 WeeksExperimentalTDF plus Peg-IFN for 16 weeks, followed by TDF alone for an additional 32 weeks
Receives: Drug: TDF; Drug: Peg-IFN
TDF 120 WeeksActive comparatorTDF monotherapy for 120 weeks
Receives: Drug: TDF
Peg-IFN 48 WeeksActive comparatorPeg-IFN monotherapy for 48 weeks
Receives: Drug: Peg-IFN

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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.

    Measured: Baseline; Week 72

Secondary outcomes (13)

  1. 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

    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.

    Measured: Baseline; Week 72

  2. Percentage of Participants With HBsAg Loss at 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.

    Measured: Baseline; Weeks 96 and 120

  3. Percentage of Participants With HBsAg Seroconversion at 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.

    Measured: Baseline; Weeks 72, 96, and 120

  4. Percentage of Participants With HBeAg Loss and Seroconversion at 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.

    Measured: Baseline; Week 72

  5. Percentage of Participants With HBeAg Loss and Seroconversion at 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.

    Measured: Baseline; Week 96

  6. Percentage of Participants With HBeAg Loss and Seroconversion at 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.

    Measured: Baseline; Week 120

  7. Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at 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.

    Measured: Week 72

  8. Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at 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.

    Measured: Week 96

  9. Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at 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.

    Measured: Week 120

  10. Percentage of Participants With Normal ALT at 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.

    Measured: Week 72

  11. Percentage of Participants With Normal ALT at 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.

    Measured: Week 96

  12. Percentage of Participants With Normal ALT at 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.

    Measured: Week 120

  13. Percentage of Participants Who Required Retreatment

    Participants in the TDF 120 week group were not eligible to enter the retreatment phase and are not presented.

    Measured: Up to 120 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionAug 2014
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
751 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01277601
Sponsor's protocol ID
GS-US-174-0149
Other IDs
2010-024586-45
Status last verified
Jul 2016
First submitted
13 Jan 2011
Last updated
26 Aug 2016
Data monitoring committee
No

Publications

  • Marcellin P, Ahn SH, Ma X, Caruntu FA, Tak WY, Elkashab M, Chuang WL, Lim SG, Tabak F, Mehta R, Petersen J, Foster GR, Lou L, Martins EB, Dinh P, Lin L, Corsa A, Charuworn P, Subramanian GM, Reiser H, Reesink HW, Fung S, Strasser SI, Trinh H, Buti M, Gaeta GB, Hui AJ, Papatheodoridis G, Flisiak R, Chan HL; Study 149 Investigators. Combination of Tenofovir Disoproxil Fumarate and Peginterferon alpha-2a Increases Loss of Hepatitis B Surface Antigen in Patients With Chronic Hepatitis B. Gastroenterology. 2016 Jan;150(1):134-144.e10. doi: 10.1053/j.gastro.2015.09.043. Epub 2015 Oct 8.

    PubMed 26453773

  • Chan HL, Elkhashab M, Trinh H, Tak WY, Ma X, Chuang WL, Kim YJ, Martins EB, Lin L, Dinh P, Charuworn P, Foster GR, Marcellin P. Association of baseline vitamin D levels with clinical parameters and treatment outcomes in chronic hepatitis B. J Hepatol. 2015 Nov;63(5):1086-92. doi: 10.1016/j.jhep.2015.06.025. Epub 2015 Jul 2.

    PubMed 26143444

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing TDF and Peg-IFN in people with Chronic Hepatitis B, run by Gilead Sciences at 171 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 171 sites in United States, Australia, South Korea, Taiwan, India and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01277601, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2016.

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