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:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01277601
First received: January 13, 2011
Last updated: February 25, 2013
Last verified: October 2012
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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:
Drug Information available for:
Formic acid
Tenofovir
Tenofovir Disoproxil Fumarate
Recombinant Hepatitis B vaccine
Hepatitis A Vaccines
U.S. FDA Resources
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)
| Estimated Enrollment: | 720 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 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 HaBV 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, HCV or HDV
- Pregnant
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01277601
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Hide Study LocationsLocations
| 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: | February 25, 2013 |
| 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 June 13, 2013