Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination With Peginterferon α-2a vs Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon α-2a Monotherapy for 48 Weeks in Chronic Hepatitis B(CHB). (TDF PEG CHB)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01277601
First received: January 13, 2011
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to evaluate the safety and efficacy of Tenofovir Disoproxil Fumarate (TDF) plus Peginterferon α-2a (PEG) combination therapy versus standard of care TDF monotherapy or PEG monotherapy in non-cirrhotic CHB subjects as determined by loss of HBsAg.


Condition Intervention Phase
Chronic Hepatitis B
Drug: Tenofovir disoproxil fumarate 300 mg(TDF) and Peginterferon α-2a 180 µg(PEG)
Drug: Tenofovir Disoproxil Fumarate, Peginterferon α-2a
Drug: Tenofovir Disoproxil Fumarate
Drug: Peginterferon α-2a
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • HBsAg loss at Week 72 following treatment with 48 weeks of TDF plus PEG combination versus PEG alone for 48 weeks or TDF alone. [ Time Frame: 72 Weeks ] [ Designated as safety issue: No ]
    The proportion of subjects with HBsAg loss at Week 72 following treatment with 48 weeks of TDF plus PEG combination versus PEG alone for 48 weeks or TDF alone.


Secondary Outcome Measures:
  • HBsAg loss at Week 72 following treatment with TDF (48 weeks) plus PEG (16 weeks) combination versus PEG alone for 48 weeks or TDF alone [ Time Frame: 72 Weeks ] [ Designated as safety issue: No ]
    The proportion of subjects with HBsAg loss at Week 72 following treatment with TDF (48 weeks) plus PEG (16 weeks) combination versus PEG alone for 48 weeks or TDF alone.

  • HBsAg loss at Week 96 and Week 120 [ Time Frame: Week 96 and Week 120 ] [ Designated as safety issue: No ]
    The proportion of subjects who experience HBsAg loss at Week 96 and Week 120

  • Rate of quantitative HBsAg decline during the study [ Time Frame: Baseline through Week 120 ] [ Designated as safety issue: No ]
    The rate of quantitative HBsAg decline during the study

  • HBV DNA level < 400 copies/mL at Weeks 72, 96 and 120 [ Time Frame: Weeks 72, 96 and 120 ] [ Designated as safety issue: No ]
    The proportion of subjects with virological response (HBV DNA level < 400 copies/mL) at Weeks 72, 96 and 120

  • HBeAg loss and seroconversion, and HBsAg seroconversion at Weeks 72, 96 and 120 [ Time Frame: Weeks 72, 96 and 120 ] [ Designated as safety issue: No ]
    The proportion of subjects with serological response (HBeAg loss and seroconversion, and HBsAg seroconversion) at Weeks 72, 96 and 120

  • ALT<ULN at Weeks 72, 96 and 120 [ Time Frame: Weeks 72, 96 and 120 ] [ Designated as safety issue: No ]
    The proportion of subjects who experience biochemical response (ALT<ULN) at Weeks 72, 96 and 120

  • Requiring re-initiation or change of therapy while on therapy or post-treatment [ Time Frame: Baseline through Week 120 ] [ Designated as safety issue: Yes ]
    The proportion of subjects who require re-initiation or change of therapy while on therapy or post-treatment

  • Virological response [ Time Frame: Baseline through Week 120 ] [ Designated as safety issue: No ]
    Evaluate virological response (HBV DNA < 400copies/mL)


Enrollment: 751
Study Start Date: March 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A-Treatment Arm 1
Subjects will be treated with Tenofovir disoproxil fumarate 300 mg(TDF) and Peginterferon α-2a 180 µg(PEG) concomitantly for 48 weeks.
Drug: Tenofovir disoproxil fumarate 300 mg(TDF) and Peginterferon α-2a 180 µg(PEG)
Tenofovir disoproxil fumarate 300 mg(TDF)PO once daily in combination with Peginterferon α-2a 180 µg(PEG) subcutaneous injection once weekly for 48 weeks.
Drug: Tenofovir Disoproxil Fumarate, Peginterferon α-2a
Tenofovir disoproxil fumarate 300 mg PO once daily in combination with Peginterferon α-2a 180 µg subcutaneous injection once weekly for 16 weeks and Tenofovir disoproxil fumarate 300 mg PO once daily for additional 32 weeks.
Experimental: Arm B- Treatment arm 2
Subjects will be treated with Tenofovir disoproxil fumarate 300 mg(TDF) and Peginterferon α-2a 180 µg(PEG) concomitantly for 16 weeks followed by Tenofovir disoproxil fumarate 300 mg(TDF)alone for another 32 weeks (total 48 weeks).
Drug: Tenofovir Disoproxil Fumarate, Peginterferon α-2a
Tenofovir disoproxil fumarate 300 mg PO once daily in combination with Peginterferon α-2a 180 µg subcutaneous injection once weekly for 16 weeks and Tenofovir disoproxil fumarate 300 mg PO once daily for additional 32 weeks.
Drug: Tenofovir Disoproxil Fumarate
Tenofovir disoproxil fumarate 300 mg PO once daily for 120 weeks.
Drug: Peginterferon α-2a
Peginterferon α-2a 180 µg subcutaneous injection once weekly for 48 weeks.
Active Comparator: Arm C- Active control Arm 1
Subjects will be treated with Tenofovir disoproxil fumarate 300 mg(TDF) continuously through 120 weeks.
Drug: Tenofovir Disoproxil Fumarate
Tenofovir disoproxil fumarate 300 mg PO once daily for 120 weeks.
Active Comparator: Arm D- Active control Arm 2
Subjects will be treated with Peginterferon α-2a 180 µg(PEG) for 48 weeks.
Drug: Peginterferon α-2a
Peginterferon α-2a 180 µg subcutaneous injection once weekly for 48 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult subjects (aged 18-75) with CHB (positive for serum HBsAg or HBV DNA for at least 6 months)prior to baseline.
  • Anti-HBV treatment naïve subjects and subjects who have taken oral anti-HBV nucleoside therapy with the last dose ≥ 24 weeks prior to screening are also eligible.
  • Positive or negative for HBeAg
  • HBV DNA ≥ 20,000 IU/ml for HBeAg+ subjects and HBV DNA ≥ 2,000 IU/ml for HBeAg- subjects
  • 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
  • A negative serum pregnancy test is required for female subjects of childbearing potential
  • All sexually active female subjects of childbearing potential must agree to use a protocol recommended method of contraception during heterosexual intercourse throughout the study and for 30 days following the last dose of study medication.
  • Lactating female subjects 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 renal, cardiovascular, pulmonary, neurological, autoimmune disease or bone disease (e.g., osteomalacia,chronic osteomyelitis, osteogenesis imperfecta, osteochondrosis, multiple bone fractures)
  • Absolute neutrophil count < 1,500/mm3, platelet < 100,000/mm3, hemoglobin < 10 g/dL (female) or < 11 g/dL (male)
  • History of severe depression or severe psychiatric disease
  • Thyroid dysfunction
  • Co-infection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV)
  • Pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01277601

  Hide Study Locations
Locations
United States, California
Asian Pacific Liver Center
Los Angeles, California, United States, 90057
Stanford University Medical Center,750 Welch Road, Ste. 210
Palo Alto, California, United States, 94304-5350
Research and Education Inc
San Diego, California, United States, 92105
San Jose Gastroenterology
San Jose, California, United States, 95128
United States, Florida
Centre for Advanced Gastroenterology
Maitland, Florida, United States, 32751
University of Miami / Jackson Memorial Medical Center
Miami, Florida, United States, 33136
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Louisiana
LSU Gastroenterology/Center for Digestive Diseases
New Orleans, Louisiana, United States, 70115
United States, Maryland
Digestive Disease Associates
Baltimore, Maryland, United States, 21229
United States, Massachusetts
Tufts Medical Center,800 Washington Street
Boston, Massachusetts, United States, 02111
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, New Jersey
ID Care, Inc.
Hillsborough, New Jersey, United States, 08844
United States, New York
132-21 41 Ave. Suite 1A
Flushing, New York, United States, 11355
North Shore University Hospital
Great Neck, New York, United States, 11021
Beth Israel Medical Center
New York, New York, United States, 10003
New York Univ. Medical Center
New York, New York, United States, 10021
Weill Cornell Medical College of Cornell University, 1305 York Ave. 4th floor
New York, New York, United States, 10021
United States, Pennsylvania
121 N. 9th Street
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Kelsey Research Foundation
Houston, Texas, United States, 77005
Advanced Liver Therapies at St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030
Liver Associates of Texas,
Houston, Texas, United States, 77030
United States, Utah
University of Utah, 30 North 1900 East ,4R118 SOM
Salt Lake City, Utah, United States, 84132
United States, Virginia
McGuire Research Institute
Richmond, Virginia, United States, 23298
Liver Institute of Virginia, Bon Secours Health System
Richmond, Virginia, United States, 23249
Australia, New South Wales
Royal Prince Alfred Hospital,AW Morrow Gastroenterology and Liver Center, Level 9 E- Block
Camperdown, New South Wales, Australia, 2050
Concord Repatriation General Hospital,Department of Gastroenterology
Concord, New South Wales, Australia, 2137
Saint George's Hospital,Pitney Building, Second Floor,Belgrave Street
Kogarah, New South Wales, Australia, NSW 2217
Storr Liver Unit- Westmead Hospital,Hawkesbury Road
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Princess Alexandra Hospital,Dept of Gastroenterology and Hepatology,Level 4 Building 1 199 Ipswich Road
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Flinders Medical Center, 1 Flinders Drive,Bedford Park
Adelaide, South Australia, Australia, 5042
Royal Adelaide Hospital,Dept. of Gastroenterology and Hepatology, North Terrace
Adelaide SA, South Australia, Australia, 5000
Australia, Victoria
Monash Medical Centre,Gastrointestinal and Liver Unit,246 Clayton Road
Clayton, Victoria, Australia, 3168
Saint Vincents Hospital,Daly Wing 41 Victoria Parade
Fitzroy, Victoria, Australia, 3065
Western Hospital,Dept. of Medicine,Gordon Street
Footscray, Victoria, Australia, 3011
Austin Health,Dept. of Hepatology,145-163 Studley Road
Heidelberg, Victoria, Australia, 3081
Box Hill Hospital,Eastern Health,Level 2,5 Arnold Street,Box Hill
Melbourne, Victoria, Australia
Alfred Hospital,Commercial Road/ Level 4 Main Ward Block
Melbourne, Victoria, Australia, 3004
Royal Melbourne Hospital,Victorian Inf. Diseases Services,Grattan Street
Parkville, Victoria, Australia, 3050
Australia
Fremantle Hospital,B2 Clinic, Alma Street,
Fremantle, Australia, 6160
Royal Brisbane & Women's Hospital,C5 Clinical Sciences Building,Butterfield Street
Herston, Australia, QLD 4029
Liverpool Hospital,Gastroenterology Department,Cr Elizabeth and Goulburn Streets
Liverpool, Australia, NSW 2170
Sir Charles Gairdner Hospital,Dept. of Gastroenterology Hepatology,6th Floor G Block
Nedlands, Australia, 6009
Royal Perth Hospital,Wellington Street
Perth, Australia, 6001
Canada, Alberta
Heritage Med Research Clinic, Univ of Calgary
Calgary, Alberta, Canada, T2N 4Z6
University of Alberta,Zeidler Ledcore Centre
Zeidler Ledcore Centre, Alberta, Canada, T6G 2X8
Canada, British Columbia
Gastrointestional Research Institute
Vancouver, British Columbia, Canada, V6Z 2K5
Liver and Intestinal Research Centre
Vancouver, British Columbia, Canada, V5Z 1H2
Gordon & Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
The Ottawa Hospital,Division of Infectious Diseases,G12-501 Smyth Road
Ottawa, Ontario, Canada, K1H 8L6
Toronto Liver Centre
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
France
Service Hepatologie- Centre Pierre Abrami
Clichy, Cedex, France, 92110
Hôpital de la Croix Rousse, Service Hepatogastro enterologie-endoscopie
Lyon, Cedex, France, 69288
Hopital Tenon- 4 Rue de la Chine
Paris, France, 75020
CHU de Rennes,2 rue Henri Le Guilloux
Rennes, 35, France, 35000
Hopital Charles Nicolle
Rouen, France, 76031
Centre Hospitalier Regional et Universitaire de Strasbourg, Hopital Civil
Strasbourg, France, 67091
Centre Hospitalier Universitaire Purpan
Toulouse, France, 31059
Hopital Paul Brousse
Villejuif Cedex, France, 94804
Germany
Johannes Gutenberg-Universitat Mainz,
Mainz, Rheinland-pfalz, Germany, 55131
Charite Berlin, Campus Virchow-Klinikum- Augustenburger Platz 1
Berlin, Germany, 13353
Universitätsklinikum Essen - klinikum für Gastroenterolgie und Hepatologie,
Essen, Germany, 45122
Johann-Wolfgang-Goethe Universitat,
Frankfurt, Germany, 60590
Asklepios Westklinikum
Hamburg, Germany, 20251
Medizinische Hochschule Hannover,Hastroenterologie und Hepatologie
Hannover, Germany, 30625
Universitatsklinik Koln
Köln, Germany, 50937
Universitatsklinikum Leipzig
Leipzig, Germany, 04103
Greece
Athens Univ Med School,Int Med 2nd,Vas Sofias Street 114
Athens, Greece, 115 27
University Hospital of Patras,Department of Internal Medicine,Rio, Patra
Patra, Greece, 26500
Hippokration Hospital of Thessalonica,49 Konstantinoupoleous Str.
Thessaloniki, Greece, 54642
Hong Kong
University of Hong Kong ,Queen Mary Hospital,102 Pokfulan Road
Hong Kong, Hong Kong
Princess Margaret Hospital,2-10 Princess Margaret Hosp Rd
Kowloon, Hong Kong
Prince of Wales Hospital, 9/F,
Shatin, Hong Kong
Alice Ho Miu Ling Nethersole Hospital, 11 Chuen On Road
Tai Po, Hong Kong
India
Global Hospital, Lakdi Ka Pul
Hyderabad, Andhra Pradesh, India, 500004
Institute of digestive and liver disease, Ganeshguri
Guwahati, Assam, India, 781 006
Vedanta Hospital, Gastroenterology and Endoscopy Clinic, 2nd Floor, Near Samved Hospital, Navrangpura
Ahmedabad, Gujarat, India, 380009
Liver Clinic, 203-204, Narmada Complex, Near Kadiwal School, Ring Road
Surat, Gujarat, India, 395002
Manipal Hospitals, 98, HAL Airport Road
Bangalore, Karnataka, India, 560017
Institute of Post Graduate Medical Education And Research,244 A, JC Bose Road
Calcutta, Kolkata, India, 700 020
Diwaliben Mohanlal Mehta Charitable Trust, 1st Foor, Khatau Mansion, 95/K Bhulabhai Desai Road
Mumbai, Maharashtra, India, 400 036
Seth GS Medical College and KEM Hospital, Acharya Donde Marg,Parel
Mumbai, Maharashtra, India, 400012
Midas Institute of Gastroenterology, Midas Height-7,Central Bazar Road, Ramdaspeth
Nagpur, Maharashtra, India, 440010
Dharmasi Hospital,Chandni Chowk, South Shivajinagar,
Sangli, Maharashtra, India, 416416
All India Institute of Medical Sciences, Ansari Nagar
Delhi, New Delhi, India, 110029
VGM Hospital, 2100, Trichy Road, Rajalakshmi Mills Stop
Coimbatore, Tamil Nadu, India, 641 005
Institute of Liver and Biliary Sciences,D-1,Vasant Kunj
New Delhi, India, 110070
Italy
Azienda Ospedaliero-Universitaria di Cagliari,S.S 554 Bivio Sestu
Monserrato, Cagliari, Italy, 09042
Fondazione IRCCS Ca Granda - Ospedale Maggiore Policlinico,via Francesco Sforza 28/35
Milano, Italy, 20122
Fondazione Centro San Raffaele del Monte Tabor
Milano, Italy, 20127
Seconda Universita degli Studi di Napoli,via Cotugno 1
Napoli, Italy, 80135
Azienda Ospedaliera di Parma,Department of Infectious Diseases and hepatology
Parma, Italy, 43100
Fondazione PTV - Policlinico Tor Vergata,via Montpellier 1
Roma, Italy, via Montpellier 1
Policlinico Umberto I, Dipartimento di Malattie Infettive e Tropicali,v.le del Policlinico 155
Rome, Italy, 00161
University of Milan,Azienda Ospedaliera San Giovanni, Battista di Torino,Dipartimento di Gastroenterologia
Torino, Italy, 10126
Korea, Republic of
SoonChunHyang University Hospital Cheonan,23-20, Byeongmyeong-dong,
Cheonan, Chungcheon, Korea, Republic of, 330-721
Yonsei Unversity Wonju College of Medicine Wonju Christian Hospital,162 ilsan-dong
Wonju, Gangwon-do, Korea, Republic of, 220-701
Korea University Ansan Hospital,516, Gojan 1-dong,516, Gojan 1-dong
Ansan-si, Gyeonggi-d, Korea, Republic of, 425-707
Bucheon St. Mary''s Hospital,2 Sosa-dong, Wonmi-gu
Bucheon, Gyeonggi-d, Korea, Republic of, 420-717
Inje University Ilsan Paik Hospital,2240, Daewha-dong,Ilsan seo-Gu
Goyang, Gyeonggi-d, Korea, Republic of, 411-706
Korea University Guro Hospital,80, Guro 2-dong,Guro-Gu
Seoul, Gyeonggi-d, Korea, Republic of, 152-703
CHA Bundang Medical Center, CHA University,351, Yatap-dong,Bundang-gu
Sungnam, Gyeonggi-d, Korea, Republic of, 463-712
Pusan National University Hospital,305 Gudeok-Ro
Busan, Gyeongsang, Korea, Republic of, 602-739
Kyungpook National University Hospital,130 Dongduk-ro
Daegu, Gyeongsang, Korea, Republic of, 700-721
Pusan National University Yangsan Hospital,Beomeo-ri, Mulgeum-eup
Yangsan, Gyeongsang, Korea, Republic of, 626-770
Digestive Disease Cntr, Konkuk Univ Hosp,4-12 Hwayang-dong
Kwangjin-gu, Seoul, Korea, Republic of, 143729
Seoul Saint Mary''s Hospital,505 Banpo-dong
Seocho-gu, Seoul, Korea, Republic of, 138-736
Gangnam Severance Hospital,146-92 Dogok-Dong,Kangnam-gu
Seoul, Korea, Republic of, 135-736
Seoul National University Hospital,101 Daehak-ro,Jongno-Gu
Seoul, Korea, Republic of, 110-744
Asan Medical Center,388-1 Pungnap-2-Dong
Seoul, Korea, Republic of, 138-736
Samsung Medical Center,50 Ilwong-dong,Gangnam-gu
Seoul, Korea, Republic of, 135-710
Netherlands
Vrije Universiteit Medisch Centrum,De Boelelaan 1117
Amsterdam, Netherlands, 1081 HV
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Erasmus MC,Afdeling Gastroenterologie,S Gravendijkwal, 230
Rotterdam, Netherlands, 3015 CE
Poland
Wojewódzki Specjalistyczny Szpital im. Dr Wladyslawa Bieganskiego w Lodzi,ulica Kniaziewicza 1/5
Lodz, Lodzkie, Poland, 91-347
Samodzielny Publiczny Szpital Kliniczny 1,Klinika Chorób Zakaznych,ulica Staszica 16
Lublin, Lubelskie, Poland, 20-081
Szpital Specjalistyczny w Chorzowie,Oddzial Obserwacyjno-Zakazny Hepatologii Zakaznej i Nabytych Niedoborów Odpornosci Klinicznej,ulica Zjednoczenia 10
Chorzów, Slaskie, Poland, 41-500
Wojewodzki Szpital Specjalistyczny im Dluskeigo, ul Zurawia 14
Bialystok, Poland, 15-540
Klinika Chorob Zakaznych AM,Szpital Obserwacyno-Zakazny im.T.Browicza,ul. Sw. Floriana 12 Str.
Bydgoszcz, Poland, 85-030
Szpital Uniwersytecki w Krakowie,Klinika Chorob Zakaznych I Hepatologii,ul.Sniadeckich 5
Krakow, Poland, 31-501
Oddziak Obserwacyjno-Zakazny, ul. Kniaziewicza 1/5,Klinika Obserwacyjno - Zakazna
Lodz, Poland, 91-347
SP ZOZ Wojewodzki Szpital Zakazny w Warszawie,ul. Wolska 37
Warszawa, Poland, 01-201
Portugal
Hospital de Egas Moniz,Rua da Junqueira, 126
Lisboa, Portugal, 1349-019
Hospital de Santa Maria
Lisboa, Portugal, 1649-035
Hospital São João, Alameda Professor Hernâni Monteiro
Porto, Portugal, 4200-319
Centro Hospitalar do Porto,Serviço de Gastrenterologia,Largo Prof. Abel Salazar
Porto, Portugal, 4099-001
Romania
Neomed Research,Strada Crisului Nr.1.
Brasov, Romania, 500283
Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"
Bucharest, Romania, 021105
Institutul National de Boli Infectioase Prof.Dr. Matei Bals
Bucharest, Romania, 021105
Spitalul Clinic de Boli Infectioase "Dr. Victor Babes"
Bucharest, Romania, 030303
Colentina Clinical Hospital
Bucuresti, Romania, 020125
Spitalul Clinic Judetean Sibiu
Sibiu, Romania, 550245
Policlinic Algomed SRL,4 Lucian Blaga Str.
Timisoara, Romania, 300002
Singapore
National University Hospital Singapore,Div of Gastroenterology and Hepatology,1E Kent Ridge Road, Dept of Med
Singapore, Singapore, 119228
Tan Tock Seng Hospital,11 Jalan Tan Tock Seng
Singapore, Singapore, 308433
Changi General Hospital,Division of Gastroenterology,Depart of Medicine, 2 Simei Street 3
Singapore, Singapore, 529889
Singapore General Hospital,Ntnl Univ Hosp, Dept of Gastroenterology,Outram Road
Singapore, Singapore, 169608
Spain
Hospital General Universitari Vall d' Hebron
Barcelona, Spain, 08035
Hospital Carlos III, Digestive Department, Sinesio Delgado 10
Madrid, Spain, 28029
Hospital Universitario de La Princesa,Calle Diego de León 62
Madrid, Spain, 28006
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 4103
Hospital Virgen de la Victoria
Sevilla, Spain, 41013
Hospital Meixoeiro,Meixoeiro, S/N
Vigo, Pontevedra, Spain, 36200
Taiwan
Far-Eastern Memorial Hosp,Div.of Hepato-Gastro,No.21, Sec. 2, Nanya S. Rd.,
New Taipei City, Banciao Dist, Taiwan, 220
Chang Gung Memorial Hospital - Linkou,Chang Gung Univ Coll of Medicine,Number 5, Fu-Hsing Street
Tao-Yuan, Taoyuan, Taiwan, 33305
Changhua Christain Hospital,No.135 Nanhsiao Street
Changhua,, Taiwan, 500
Chiayi Christian Hosp,Div. of Hepato-Gastro,No.539 ,Jhongsiao Rd
Chia-Yi, Taiwan, 60002
Buddhist Tzu Chi General Hospital,Div. of Hepato-Gastroenterology,No. 707, Sec. 3, Chung Yang Rd.
Hualien, Taiwan, 970
Chang Gung Memorial Hospital,3F Liver Unit,123 Ta- Pei Rd Niao-Sung Hsiang
Kaohsiung, Taiwan, 833
Kaohsiung Medical University Hospital,Hepatobiliary Division,100 Shih-Chuan 1st Rd.
Kaosiung, Taiwan, 807
Chang Gung Medical Foundation-Keelung,Chang Gung Med FDN -Keelung,No.222, Mai-Chin Road
Keelung Town/KEELUNG CITY, Taiwan, 20401
China Medical University Hospital
Taichung, Taiwan, 404
Taichung Veterans Genl Hosp,No. 160, Sec. 3, Chung-Kang Rd
Taichung, Taiwan, 40705
Chung Shan Medical University Hospital,,Div. of Hepato-Gastro,Number 110, Section 1, Chien-Kuo North Road
Taichung, Taiwan, 40201
National Cheng Kung University Hospital,Clin Pharm Outpatient Bldg 1F
Tainan, Taiwan, 70428
National Taiwan University Hospital,
Taipei, Taiwan, 10002
Cathay General Hospital,280 Jen-Ai Road, Sec. 4
Taipei, Taiwan, 11008
Turkey
Ankara Üniversitesi Tip Fakültesi Gastroenteroloji Bilim Dali
Dikimevi, Ankara, Turkey, 06100
Hacettepe Üniversitesi Tip Fakültesi
Ankara, Turkey, 06100
Gaziantep Univ. Med. Faculty
Gaziantep, Turkey, 27300
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, Turkey, 34098
Istanbul Universitesi Cerrahpassa Tip Fakultesi Hastanesi,Gastroenteroloji Bilim Pali
Mersin, Turkey, 33079
United Kingdom
Queen Elizabeth Hospital,
Birmingham, WSTMID, United Kingdom, B15 2TH
Royal Free Hospital
Hampstead,London, United Kingdom, NW3 2QG
Barts & The London NHS Trust,Centre For Gastroenterology
London, United Kingdom, E1 2AT
King's College Hospital,Institute of Liver Studies
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01277601     History of Changes
Other Study ID Numbers: GS-US-174-0149
Study First Received: January 13, 2011
Last Updated: March 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Chronic Hepatitis B
Hep B
Non cirrhotic
Treatment naive
Tenofovir disoproxil fumarate (TDF)
Peginterferon α-2a (PEG)

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Tenofovir
Tenofovir disoproxil
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on April 20, 2014