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

PHASE4CompletedINTERVENTIONAL
Enrollment

751

Participants

Timeline

Start Date

April 30, 2011

Primary Completion Date

August 31, 2014

Study Completion Date

July 31, 2015

Conditions
Chronic Hepatitis B
Interventions
DRUG

TDF

TDF 300 mg tablets administered orally once daily

DRUG

Peg-IFN

Peg-IFN 180 µg administered via subcutaneous injection once weekly

Trial Locations (171)

Unknown

Asian Pacific Liver Center, Los Angeles

Stanford University Medical Center, Palo Alto

Research and Education Inc, San Diego

San Jose Gastroenterology, San Jose

Avail Clinical Research, LLC, DeLand

Centre for Advanced Gastroenterology, Maitland

University of Miami / Jackson Memorial Medical Center, Miami

University of Chicago, Chicago

LSU Gastroenterology/Center for Digestive Diseases, New Orleans

Tulane University Hospital and Clinic, New Orleans

Digestive Disease Associates, Baltimore

Tufts Medical Center, Boston

Henry Ford Hospital, Detroit

ID Care, Inc., Hillsborough

Medical Procare, PLLC, Flushing

North Shore University Hospital, Great Neck

Beth Israel Medical Center, New York

New York Univ. Medical Center, New York

Weill Cornell Medical College of Cornell University, New York

Private Practice, Philadelphia

Advanced Liver Therapies at St. Luke's Episcopal Hospital, Houston

Kelsey Research Foundation, Houston

Liver Associates of Texas,, Houston

University of Utah, Salt Lake City

Liver Institute of Virginia, Bon Secours Health System, Richmond

McGuire Research Institute, Richmond

Royal Prince Alfred Hospital, Camperdown

Concord Repatriation General Hospital, Concord

Saint George's Hospital, Kogarah

Liverpool Hospital,Gastroenterology Department, Liverpool

Westmead Hospital, Westmead

Royal Brisbane & Women's Hospital, Herston

Princess Alexandra Hospital, Woolloongabba

Flinders Medical Center, Adelaide

Royal Adelaide Hospital, Adelaide SA

Monash Medical Centre, Clayton

Saint Vincents Hospital, Fitzroy

Western Hospital, Footscray

Austin Health, Heidelberg

Alfred Hospital, Melbourne

Box Hill Hospital, Melbourne

Royal Melbourne Hospital, Parkville

Fremantle Hospital, Fremantle

Sir Charles Gairdner Hospital, Nedlands

Royal Perth Hospital, Perth

Heritage Med Research Clinic, Univ of Calgary, Calgary

University of Alberta, Zeidler Ledcore Centre, Zeidler Ledcore Centre

Gastrointestional Research Institute, Vancouver

Gordon & Leslie Diamond Health Care Centre, Vancouver

Liver and Intestinal Research Centre, Vancouver

The Ottawa Hospital,Division of Infectious Diseases, Ottawa

Toronto General Hospital, Toronto

Toronto Liver Centre, Toronto

Hôpital Beaujon, Service Hepatologie- Centre Pierre Abrami, Clichy

Hôpital de la Croix Rousse, Lyon

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

Johannes Gutenberg-Universitat Mainz,, Mainz

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

Ippokratio Hospital Salonica, Thessaloniki

Ippokratio Hospital Athens, Attica

General University Hospital of Patras, Pátrai

Hippokration General Hospital of Thessaloniki, Thessaloniki

Queen Mary Hospital, Hong Kong

Princess Margaret Hospital, Kowloon

Prince of Wales Hospital, Shatin

Alice Ho Miu Ling Nethersole Hospital, Tai Po

Global Hospital, Lakdi Ka Pul, Hyderabad

Institute of digestive and liver disease, Dispur Hospital Ganeshguri, Guwahati

Vedanta Institute of Medical Sciences, Ahmedabad

Liver Clinic, Surat

Manipal Hospitals, Bangalore

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

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

Midas Institute of Gastroenterology, Nagpur

Dharamasi Hospital,Chandni Chowk, South Shivajinagar,, Sangli

All India Institute of Medical Sciences, Ansari Nagar, Delhi

Institute of Liver and Biliary Sciences, New Delhi

VGM Hospital, Coimbatore

Institute of Post Graduate Medical Education And Research, Kolkata

Azienda Ospedaliero-Universitaria di Cagliari, Monserrato

Fondazione IRCCS Ca Granda - Ospedale Maggiore Policlinico, Milan

Ospedale San Raffaele, Milan

Seconda Universita degli Studi di Napoli, Napoli

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

Academisch Medisch Centrum, Amsterdam

Vrije Universiteit Medisch Centrum, Amsterdam

Erasmus Medisch Centrum, Rotterdam

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

Szpital Specjalistyczny w Chorzowie, Chorzów

Wojewodzki Szpital Specjalistyczny Kazimierza Dluskeigo w Bialymstoku, Bialystok

Wojewódzki Szpital Obserwacyjno Zakazny im. Tadeusza Browicza, Bydgoszcz

Szpital Uniwersytecki w Krakowie, Krakow

Wojewódzki Specjalistyczny Szpital im. Dr Wladyslawa Bieganskiego w Lodzi, Lodz

SP ZOZ Wojewodzki Szpital Zakazny, Warsaw

Wojewódzki Specjalistyczny Szpital im. Dr Wladyslawa Bieganskiego w Lodzi, Lodz

Hospital de Egas Moniz, Lisbon

Hospital de Santa Maria, Lisbon

Centro Hospitalar do Porto, Porto

Hospital São João, Porto

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

Changi General Hospital, Singapore

National University Hospital Singapore, Singapore

Singapore General Hospital, Singapore

Tan Tock Seng Hospital, Singapore

SoonChunHyang University Hospital Cheonan, Cheonan

Yonsei Unversity Wonju College of Medicine Wonju Christian Hospital, Wŏnju

Korea University Ansan Hospital, Ansan-si

Bucheon St. Mary's Hospital, Bucheon-si

Korea University Guro Hospital, Seoul

CHA Bundang Medical Center, CHA University, Sungnam

Pusan National University Hospital, Busan

Kyungpook National University Hospital, Daegu

Pusan National University Yangsan Hospital, Yangsan

Inje University Busan Paik Hospital, Busan

Inje University Ilsan Paik Hospital, Goyang, Gyeonggi-Do

Digestive Disease Cntr, Konkuk Univ Hosp, Kwangjin-gu, Seoul

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

Hospital Universitario de La Princesa, Madrid

Hospital General Universitari Vall d' Hebron, Barcelona

Hospital Carlos III, Madrid

Hospital Virgen de la Victoria, Málaga

Hospital Universitario Virgen del Rocio, Seville

Hospital Meixoeiro, Vigo, Pontevedra

Far-Eastern Memorial Hosp, New Taipei City

Chang Gung Medical Foundation.LinKou Branch, Taoyuan District

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

China Medical University Hospital, Taichung

Chung Shan Medical University Hospital, Taichung

Taichung Veterans Genl Hosp, Taichung

National Cheng Kung University Hospital, Tainan City

Cathay General Hospital, Taipei

National Taiwan University Hospital, Taipei

Ankara Üniversitesi Tip Fakültesi, Ankara

Hacettepe Üniversitesi Tip Fakültesi, 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

The Queen Elizabeth Hospital, Birmingham, Wstmid

Royal Free Hospital, Hampstead,London

Barts and The London NHS Trust, London

King's College Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY