Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (Peg-IFN) Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis B
NCT ID: NCT01277601
Last Updated: 2016-08-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
751 participants
INTERVENTIONAL
2011-04-30
2015-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TDF+Peg-IFN 48 Weeks
TDF plus Peg-IFN for 48 weeks
TDF
TDF 300 mg tablets administered orally once daily
Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
TDF 48 Weeks + Peg-IFN 16 Weeks
TDF plus Peg-IFN for 16 weeks, followed by TDF alone for an additional 32 weeks
TDF
TDF 300 mg tablets administered orally once daily
Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
TDF 120 Weeks
TDF monotherapy for 120 weeks
TDF
TDF 300 mg tablets administered orally once daily
Peg-IFN 48 Weeks
Peg-IFN monotherapy for 48 weeks
Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Interventions
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TDF
TDF 300 mg tablets administered orally once daily
Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Belinda Jump
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Asian Pacific Liver Center
Los Angeles, California, United States
Stanford University Medical Center
Palo Alto, California, United States
Research and Education Inc
San Diego, California, United States
San Jose Gastroenterology
San Jose, California, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Centre for Advanced Gastroenterology
Maitland, Florida, United States
University of Miami / Jackson Memorial Medical Center
Miami, Florida, United States
University of Chicago
Chicago, Illinois, United States
LSU Gastroenterology/Center for Digestive Diseases
New Orleans, Louisiana, United States
Tulane University Hospital and Clinic
New Orleans, Louisiana, United States
Digestive Disease Associates
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
ID Care, Inc.
Hillsborough, New Jersey, United States
Medical Procare, PLLC
Flushing, New York, United States
North Shore University Hospital
Great Neck, 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
New York, New York, United States
Private Practice
Philadelphia, Pennsylvania, 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,
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Liver Institute of Virginia, Bon Secours Health System
Richmond, Virginia, United States
McGuire Research Institute
Richmond, Virginia, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Saint George's Hospital
Kogarah, New South Wales, Australia
Liverpool Hospital,Gastroenterology Department
Liverpool, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Royal Brisbane & Women's Hospital
Herston, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Flinders Medical Center
Adelaide, South Australia, Australia
Royal Adelaide Hospital
Adelaide SA, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Saint Vincents Hospital
Fitzroy, Victoria, Australia
Western Hospital
Footscray, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Box Hill Hospital
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Fremantle Hospital
Fremantle, , Australia
Sir Charles Gairdner Hospital
Nedlands, , Australia
Royal Perth Hospital
Perth, , Australia
Heritage Med Research Clinic, Univ of Calgary
Calgary, Alberta, Canada
University of Alberta, Zeidler Ledcore Centre
Zeidler Ledcore Centre, Alberta, Canada
Gastrointestional Research Institute
Vancouver, British Columbia, Canada
Gordon & Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada
Liver and Intestinal Research Centre
Vancouver, British Columbia, Canada
The Ottawa Hospital,Division of Infectious Diseases
Ottawa, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Toronto Liver Centre
Toronto, Ontario, Canada
Hôpital Beaujon, Service Hepatologie- Centre Pierre Abrami
Clichy, Cedex, France
Hôpital de la Croix Rousse
Lyon, Cedex, France
Hopital Tenon
Paris, , France
Centre Hospitalier Universitaire de Rennes
Rennes, , France
Hopital Charles Nicolle
Rouen, , France
Centre Hospitalier Regional et Universitaire de Strasbourg, Hopital Civil
Strasbourg, , France
Centre Hospitalier Universitaire Purpan
Toulouse, , France
Hopital Paul Brousse
Villejuif, , France
Johannes Gutenberg-Universitat Mainz,
Mainz, Rhineland-Palatinate, Germany
Charite Berlin
Berlin, , Germany
Universitatsklinik Koln
Cologne, , Germany
Universitätsklinikum Essen - klinikum für Gastroenterolgie und Hepatologie,
Essen, , Germany
Johann-Wolfgang-Goethe Universitat,
Frankfurt, , Germany
Asklepios Westklinikum
Hamburg, , Germany
Medizinische Hochschule Hannover,Hastroenterologie und Hepatologie
Hanover, , Germany
Universitatsklinikum Leipzig
Leipzig, , Germany
Ippokratio Hospital Salonica
Thessaloniki, Attica, Greece
Ippokratio Hospital Athens
Attica, , Greece
General University Hospital of Patras
Pátrai, , Greece
Hippokration General Hospital of Thessaloniki
Thessaloniki, , Greece
Queen Mary Hospital
Hong Kong, , Hong Kong
Princess Margaret Hospital
Kowloon, , Hong Kong
Prince of Wales Hospital
Shatin, , Hong Kong
Alice Ho Miu Ling Nethersole Hospital
Tai Po, , Hong Kong
Global Hospital, Lakdi Ka Pul
Hyderabad, Andhra Pradesh, India
Institute of digestive and liver disease, Dispur Hospital Ganeshguri
Guwahati, Assam, India
Vedanta Institute of Medical Sciences
Ahmedabad, Gujarat, India
Liver Clinic
Surat, Gujarat, India
Manipal Hospitals
Bangalore, Karnataka, 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
Mumbai, Maharashtra, India
Midas Institute of Gastroenterology
Nagpur, Maharashtra, India
Dharamasi Hospital,Chandni Chowk, South Shivajinagar,
Sangli, Maharashtra, India
All India Institute of Medical Sciences, Ansari Nagar
Delhi, New Delhi, India
Institute of Liver and Biliary Sciences
New Delhi, New Delhi, India
VGM Hospital
Coimbatore, Tamil Nadu, India
Institute of Post Graduate Medical Education And Research
Kolkata, West Bengal, India
Azienda Ospedaliero-Universitaria di Cagliari
Monserrato, Cagliari, Italy
Fondazione IRCCS Ca Granda - Ospedale Maggiore Policlinico
Milan, , Italy
Ospedale San Raffaele
Milan, , Italy
Seconda Universita degli Studi di Napoli
Napoli, , Italy
Azienda Ospedaliera di Parma,Department of Infectious Diseases and hepatology
Parma, , Italy
Fondazione PTV - Policlinico Tor Vergata
Roma, , Italy
Policlinico Umberto I
Rome, , Italy
University of Milan,Azienda Ospedaliera San Giovanni, Battista di Torino,Dipartimento di Gastroenterologia
Torino, , Italy
Academisch Medisch Centrum
Amsterdam, , Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Samodzielny Publiczny Szpital Kliniczny 1,Klinika Chorób Zakaznych,ulica Staszica 16
Lublin, Lublin Voivodeship, Poland
Szpital Specjalistyczny w Chorzowie
Chorzów, Silesian Voivodeship, Poland
Wojewodzki Szpital Specjalistyczny Kazimierza Dluskeigo w Bialymstoku
Bialystok, , Poland
Wojewódzki Szpital Obserwacyjno Zakazny im. Tadeusza Browicza
Bydgoszcz, , Poland
Szpital Uniwersytecki w Krakowie
Krakow, , Poland
Wojewódzki Specjalistyczny Szpital im. Dr Wladyslawa Bieganskiego w Lodzi
Lodz, , Poland
SP ZOZ Wojewodzki Szpital Zakazny
Warsaw, , Poland
Wojewódzki Specjalistyczny Szpital im. Dr Wladyslawa Bieganskiego w Lodzi
Lodz, Łódź Voivodeship, Poland
Hospital de Egas Moniz
Lisbon, , Portugal
Hospital de Santa Maria
Lisbon, , Portugal
Centro Hospitalar do Porto
Porto, , Portugal
Hospital São João
Porto, , Portugal
Neomed Research
Brasov, , Romania
Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"
Bucharest, , Romania
Institutul National de Boli Infectioase Prof.Dr. Matei Bals
Bucharest, , Romania
Spitalul Clinic Colentina
Bucharest, , Romania
Spitalul Clinic de Boli Infectioase si Tropicale "Dr. Victor Babes"
Bucharest, , Romania
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, , Romania
Cabinet Particular Policlinic Algomed SRL-Gastroenterologie
Timișoara, , Romania
Changi General Hospital
Singapore, , Singapore
National University Hospital Singapore
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
SoonChunHyang University Hospital Cheonan
Cheonan, Chungcheon, South Korea
Yonsei Unversity Wonju College of Medicine Wonju Christian Hospital
Wŏnju, Gangwon-do, South Korea
Korea University Ansan Hospital
Ansan-si, Gyeonggi-d, South Korea
Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-d, South Korea
Korea University Guro Hospital
Seoul, Gyeonggi-d, South Korea
CHA Bundang Medical Center, CHA University
Sungnam, Gyeonggi-d, South Korea
Pusan National University Hospital
Busan, Gyeongsang, South Korea
Kyungpook National University Hospital
Daegu, Gyeongsang, South Korea
Pusan National University Yangsan Hospital
Yangsan, Gyeongsang, South Korea
Inje University Busan Paik Hospital
Busan, , South Korea
Inje University Ilsan Paik Hospital
Goyang, Gyeonggi-Do, , South Korea
Digestive Disease Cntr, Konkuk Univ Hosp
Kwangjin-gu, Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Seoul Saint Mary's Hospital
Seoul, , South Korea
Hospital Universitario de La Princesa
Madrid, Madrid, Spain
Hospital General Universitari Vall d' Hebron
Barcelona, , Spain
Hospital Carlos III
Madrid, , Spain
Hospital Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Meixoeiro
Vigo, Pontevedra, , Spain
Far-Eastern Memorial Hosp
New Taipei City, Banciao Dist, Taiwan
Chang Gung Medical Foundation.LinKou Branch
Taoyuan District, Taoyuan, Taiwan
Changhua Christain Hospital
Changhua, , Taiwan
Chiayi Christian Hosp
Chiayi City, , Taiwan
Buddhist Tzu Chi General Hospital
Hualien City, , Taiwan
Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Kaohsiung Medical University Hospital
Kaosiung, , Taiwan
Chang Gung Medical Foundation-Keelung
Keelung Town/KEELUNG CITY, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
Taichung Veterans Genl Hosp
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Cathay General Hospital
Taipei, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Ankara Üniversitesi Tip Fakültesi
Ankara, Ankara, Turkey (Türkiye)
Hacettepe Üniversitesi Tip Fakültesi
Ankara, Ankara, Turkey (Türkiye)
Gaziantep Üniversitesi Tip Fakültesi, Sahinbey Arastirma ve Uygulama Hastanesi
Gaziantep, , Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, , Turkey (Türkiye)
Mersin Üniversitesi Tip Fakültesi, Saglik Arastirma ve Uygulama Hastanesi
Mersin, , Turkey (Türkiye)
The Queen Elizabeth Hospital
Birmingham, Wstmid, , United Kingdom
Royal Free Hospital
Hampstead,London, , United Kingdom
Barts and The London NHS Trust
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Countries
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References
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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.
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.
Other Identifiers
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2010-024586-45
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-174-0149
Identifier Type: -
Identifier Source: org_study_id
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