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, 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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Fremantle, Australien
- Fremantle Hospital
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Nedlands, Australien
- Sir Charles Gairdner Hospital
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Perth, Australien
- Royal Perth Hospital
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New South Wales
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Camperdown, New South Wales, Australien
- Royal Prince Alfred Hospital
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Concord, New South Wales, Australien
- Concord Repatriation General Hospital
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Kogarah, New South Wales, Australien
- Saint George's Hospital
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Liverpool, New South Wales, Australien
- Liverpool Hospital,Gastroenterology Department
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Westmead, New South Wales, Australien
- Westmead Hospital
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Queensland
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Herston, Queensland, Australien
- Royal Brisbane & Women's Hospital
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Woolloongabba, Queensland, Australien
- Princess Alexandra Hospital
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South Australia
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Adelaide, South Australia, Australien
- Flinders Medical Center
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Adelaide SA, South Australia, Australien
- Royal Adelaide Hospital
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Victoria
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Clayton, Victoria, Australien
- Monash Medical Centre
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Fitzroy, Victoria, Australien
- Saint Vincents Hospital
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Footscray, Victoria, Australien
- Western Hospital
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Heidelberg, Victoria, Australien
- Austin Health
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Melbourne, Victoria, Australien
- Alfred Hospital
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Melbourne, Victoria, Australien
- Box Hill Hospital
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Parkville, Victoria, Australien
- Royal Melbourne Hospital
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Alberta
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Calgary, Alberta, Canada
- Heritage Med Research Clinic, Univ of Calgary
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Zeidler Ledcore Centre, Alberta, Canada
- University of Alberta, Zeidler Ledcore Centre
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British Columbia
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Vancouver, British Columbia, Canada
- Gordon & Leslie Diamond Health Care Centre
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Vancouver, British Columbia, Canada
- Gastrointestional Research Institute
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Vancouver, British Columbia, Canada
- Liver and Intestinal Research Centre
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Ontario
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Ottawa, Ontario, Canada
- The Ottawa Hospital,Division of Infectious Diseases
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Toronto, Ontario, Canada
- Toronto General Hospital
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Toronto, Ontario, Canada
- Toronto Liver Centre
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Birmingham, WSTMID, Det Forenede Kongerige
- The Queen Elizabeth Hospital
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Hampstead,London, Det Forenede Kongerige
- Royal Free Hospital
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London, Det Forenede Kongerige
- King's College Hospital
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London, Det Forenede Kongerige
- Barts and The London NHS Trust
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California
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Los Angeles, California, Forenede Stater
- Asian Pacific Liver Center
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Palo Alto, California, Forenede Stater
- Stanford University Medical Center
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San Diego, California, Forenede Stater
- Research and Education Inc
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San Jose, California, Forenede Stater
- San Jose Gastroenterology
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Florida
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Deland, Florida, Forenede Stater
- Avail Clinical Research, LLC
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Maitland, Florida, Forenede Stater
- Centre for Advanced Gastroenterology
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Miami, Florida, Forenede Stater
- University of Miami / Jackson Memorial Medical Center
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Illinois
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Chicago, Illinois, Forenede Stater
- University of Chicago
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Louisiana
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New Orleans, Louisiana, Forenede Stater
- LSU Gastroenterology/Center for Digestive Diseases
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New Orleans, Louisiana, Forenede Stater
- Tulane University Hospital and Clinic
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Maryland
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Baltimore, Maryland, Forenede Stater
- Digestive Disease Associates
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Massachusetts
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Boston, Massachusetts, Forenede Stater
- Tufts Medical Center
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Michigan
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Detroit, Michigan, Forenede Stater
- Henry Ford Hospital
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New Jersey
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Hillsborough, New Jersey, Forenede Stater
- ID Care, Inc.
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New York
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Flushing, New York, Forenede Stater
- Medical Procare, PLLC
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Great Neck, New York, Forenede Stater
- North Shore University Hospital
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New York, New York, Forenede Stater
- Beth Israel Medical Center
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New York, New York, Forenede Stater
- New York Univ. Medical Center
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New York, New York, Forenede Stater
- Weill Cornell Medical College of Cornell University
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater
- Private Practice
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Texas
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Houston, Texas, Forenede Stater
- Advanced Liver Therapies at St. Luke's Episcopal Hospital
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Houston, Texas, Forenede Stater
- Kelsey Research Foundation
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Houston, Texas, Forenede Stater
- Liver Associates of Texas,
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Utah
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Salt Lake City, Utah, Forenede Stater
- University of Utah
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Virginia
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Richmond, Virginia, Forenede Stater
- McGuire Research Institute
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Richmond, Virginia, Forenede Stater
- Liver Institute of Virginia, Bon Secours Health System
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Paris, Frankrig
- Hopital Tenon
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Rennes Cedex 9, Frankrig
- Centre Hospitalier Universitaire de Rennes
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Rouen, Frankrig
- Hopital Charles Nicolle
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Strasbourg, Frankrig
- Centre Hospitalier Regional et Universitaire de Strasbourg, Hopital Civil
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Toulouse, Frankrig
- Centre Hospitalier Universitaire Purpan
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Villejuif Cedex, Frankrig
- Hopital Paul Brousse
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Cedex
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Clichy, Cedex, Frankrig
- Hôpital Beaujon, Service Hepatologie- Centre Pierre Abrami
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Lyon, Cedex, Frankrig
- Hôpital de la Croix Rousse
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Attica, Grækenland
- Ippokratio Hospital Athens
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Patra, Grækenland
- General University Hospital of Patras
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Thessaloniki, Grækenland
- Hippokration General Hospital of Thessaloniki
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Attica
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Thessaloniki, Attica, Grækenland
- Ippokratio Hospital Salonica
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Amsterdam, Holland
- Academisch Medisch Centrum
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Amsterdam, Holland
- Vrije Universiteit Medisch Centrum
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Rotterdam, Holland
- Erasmus Medisch Centrum
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Hong Kong, Hong Kong
- Queen Mary Hospital
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Kowloon, Hong Kong
- Princess Margaret Hospital
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Shatin, Hong Kong
- Prince of Wales Hospital
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Tai Po, Hong Kong
- Alice Ho Miu Ling Nethersole Hospital
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New Delhi, Indien
- Institute of Liver and Biliary Sciences
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, Indien
- Global Hospital, Lakdi Ka Pul
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Assam
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Guwahati, Assam, Indien
- Institute of digestive and liver disease, Dispur Hospital Ganeshguri
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Gujarat
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Ahmedabad, Gujarat, Indien
- Vedanta Institute Of Medical Sciences
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Surat, Gujarat, Indien
- Liver Clinic
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Karnataka
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Bangalore, Karnataka, Indien
- Manipal Hospitals
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Maharashtra
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Mumbai, Maharashtra, Indien
- Department of Hepatology, Institute of Liver Diseases, HPB Surgery and Transplant, Global Hospital
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Mumbai, Maharashtra, Indien
- Seth GS Medical College and KEM Hospital, Acharya Donde Marg,Parel
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Nagpur, Maharashtra, Indien
- Midas Institute of Gastroenterology
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Sangli, Maharashtra, Indien
- Dharamasi Hospital,Chandni Chowk, South Shivajinagar,
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New Delhi
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Delhi, New Delhi, Indien
- All India Institute of Medical Sciences, Ansari Nagar
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Tamil Nadu
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Coimbatore, Tamil Nadu, Indien
- VGM Hospital
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West Bengal
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Kolkata, West Bengal, Indien
- Institute of Post Graduate Medical Education And Research
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Milano, Italien
- Ospedale San Raffaele
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Milano, Italien
- Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico
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Napoli, Italien
- Seconda Università degli Studi di Napoli
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Parma, Italien
- Azienda Ospedaliera di Parma,Department of Infectious Diseases and hepatology
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Roma, Italien
- Fondazione PTV - Policlinico Tor Vergata
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Rome, Italien
- Policlinico Umberto I
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Torino, Italien
- University of Milan,Azienda Ospedaliera San Giovanni, Battista di Torino,Dipartimento di Gastroenterologia
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Cagliari
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Monserrato, Cagliari, Italien
- Azienda Ospedaliero-Universitaria di Cagliari
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Ankara, Kalkun
- Hacettepe Universitesi Tip Fakultesi
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Ankara, Kalkun
- Ankara Universitesi Tip Fakultesi
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Gaziantep, Kalkun
- Gaziantep Üniversitesi Tip Fakültesi, Sahinbey Arastirma ve Uygulama Hastanesi
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Istanbul, Kalkun
- Istanbul Universitesi Istanbul Tip Fakultesi
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Mersin, Kalkun
- Mersin Üniversitesi Tip Fakültesi, Saglik Arastirma ve Uygulama Hastanesi
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Busan, Korea, Republikken
- Inje University Busan Paik Hospital
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Goyang, Gyeonggi-Do, Korea, Republikken
- Inje University Ilsan Paik Hospital
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Kwangjin-gu, Seoul, Korea, Republikken
- Digestive Disease Cntr, Konkuk Univ Hosp
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Seoul, Korea, Republikken
- Seoul National University Hospital
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Seoul, Korea, Republikken
- Asan Medical Center
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Seoul, Korea, Republikken
- Konkuk University Medical Center
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Seoul, Korea, Republikken
- Samsung Medical Center
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Seoul, Korea, Republikken
- Gangnam Severance Hospital
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Seoul, Korea, Republikken
- Seoul Saint Mary's Hospital
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Chungcheon
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Cheonan, Chungcheon, Korea, Republikken
- SoonChunHyang University Hospital Cheonan
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Gangwon-do
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Wonju, Gangwon-do, Korea, Republikken
- Yonsei Unversity Wonju College of Medicine Wonju Christian Hospital
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Gyeonggi-d
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Ansan-si, Gyeonggi-d, Korea, Republikken
- Korea University Ansan Hospital
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Bucheon, Gyeonggi-d, Korea, Republikken
- Bucheon St. Mary's Hospital
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Seoul, Gyeonggi-d, Korea, Republikken
- Korea University Guro Hospital
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Sungnam, Gyeonggi-d, Korea, Republikken
- CHA Bundang Medical Center, CHA University
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Gyeongsang
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Busan, Gyeongsang, Korea, Republikken
- Pusan National University Hospital
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Daegu, Gyeongsang, Korea, Republikken
- Kyungpook National University Hospital
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Yangsan, Gyeongsang, Korea, Republikken
- Pusan National University Yangsan Hospital
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Bialystok, Polen
- Wojewodzki Szpital Specjalistyczny Kazimierza Dluskeigo w Bialymstoku
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Bydgoszcz, Polen
- Wojewódzki Szpital Obserwacyjno Zakazny im. Tadeusza Browicza
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Krakow, Polen
- Szpital Uniwersytecki w Krakowie
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Lodz, Polen
- Wojewódzki Specjalistyczny Szpital im. Dr Wladyslawa Bieganskiego w Lodzi
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Warszawa, Polen
- SP ZOZ Wojewódzki Szpital Zakazny
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Lodzkie
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Lodz, Lodzkie, Polen
- Wojewódzki Specjalistyczny Szpital im. Dr Wladyslawa Bieganskiego w Lodzi
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Lubelskie
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Lublin, Lubelskie, Polen
- Samodzielny Publiczny Szpital Kliniczny 1,Klinika Chorób Zakaznych,ulica Staszica 16
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Slaskie
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Chorzów, Slaskie, Polen
- Szpital Specjalistyczny w Chorzowie
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-
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Lisboa, Portugal
- Hospital de Santa Maria
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Lisboa, Portugal
- Hospital de Egas Moniz
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Porto, Portugal
- Centro Hospitalar do Porto
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Porto, Portugal
- Hospital Sao Joao
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Brasov, Rumænien
- Neomed Research
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Bucharest, Rumænien
- Spitalul Clinic de Boli Infecțioase și tropicale "Dr. Victor Babeș"
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Bucharest, Rumænien
- Institutul National de Boli Infectioase Prof.Dr. Matei Bals
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Bucharest, Rumænien
- Institutul National De Boli Infectioase "Prof. Dr. Matei Bals"
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Bucuresti, Rumænien
- Spitalul Clinic Colentina
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Sibiu, Rumænien
- Spitalul Clinic Judetean de Urgenta Sibiu
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Timisoara, Rumænien
- Cabinet Particular Policlinic Algomed SRL-Gastroenterologie
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-
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Singapore, Singapore
- Singapore General Hospital
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Singapore, Singapore
- Tan Tock Seng Hospital
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Singapore, Singapore
- Changi General Hospital
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Singapore, Singapore
- National University Hospital Singapore
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Barcelona, Spanien
- Hospital General Universitari Vall d' Hebron
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Madrid, Spanien
- Hospital Universitario de La Princesa
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Madrid, Spanien
- Hospital Carlos III
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Malaga, Spanien
- Hospital Virgen de la Victoria
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Sevilla, Spanien
- Hospital Universitario Virgen del Rocío
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Vigo, Pontevedra, Spanien
- Hospital Meixoeiro
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Changhua, Taiwan
- Changhua Christain Hospital
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Chia-Yi, Taiwan
- Chiayi Christian Hosp
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Hualien, Taiwan
- Buddhist Tzu Chi General Hospital
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Kaohsiung, Taiwan
- Chang Gung Memorial Hospital
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Kaosiung, Taiwan
- Kaohsiung Medical University Hospital
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Keelung Town/KEELUNG CITY, Taiwan
- Chang Gung Medical Foundation-Keelung
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Taichung, Taiwan
- China Medical University Hospital
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Taichung, Taiwan
- Chung Shan Medical University Hospital
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Taichung, Taiwan
- Taichung Veterans Genl Hosp
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Tainan, Taiwan
- National Cheng Kung University Hospital
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Taipei, Taiwan
- National Taiwan University Hospital
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Taipei, Taiwan
- Cathay General Hospital
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Banciao Dist
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New Taipei City, Banciao Dist, Taiwan
- Far-Eastern Memorial Hosp
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Taoyuan
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Tao-Yuan, Taoyuan, Taiwan
- Chang Gung Medical Foundation.LinKou Branch
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Berlin, Tyskland
- Charite Berlin
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Essen, Tyskland
- Universitätsklinikum Essen - klinikum für Gastroenterolgie und Hepatologie,
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Frankfurt, Tyskland
- Johann-Wolfgang-Goethe Universitat,
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Hamburg, Tyskland
- Asklepios Westklinikum
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Hannover, Tyskland
- Medizinische Hochschule Hannover,Hastroenterologie und Hepatologie
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Köln, Tyskland
- Universitätsklinik Köln
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Leipzig, Tyskland
- Universitatsklinikum Leipzig
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Rheinland-pfalz
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Mainz, Rheinland-pfalz, Tyskland
- Johannes Gutenberg-Universitat Mainz,
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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
- 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:
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: TDF+Peg-IFN 48 Weeks
TDF plus Peg-IFN for 48 weeks
|
TDF 300 mg tablets administered orally once daily
Andre navne:
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Andre navne:
|
|
Eksperimentel: TDF 48 Weeks + Peg-IFN 16 Weeks
TDF plus Peg-IFN for 16 weeks, followed by TDF alone for an additional 32 weeks
|
TDF 300 mg tablets administered orally once daily
Andre navne:
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Andre navne:
|
|
Aktiv komparator: TDF 120 Weeks
TDF monotherapy for 120 weeks
|
TDF 300 mg tablets administered orally once daily
Andre navne:
|
|
Aktiv komparator: Peg-IFN 48 Weeks
Peg-IFN monotherapy for 48 weeks
|
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
Tidsramme: Baseline; Week 72
|
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. |
Baseline; Week 72
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
Tidsramme: Baseline; Week 72
|
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. |
Baseline; Week 72
|
|
Percentage of Participants With HBsAg Loss at Weeks 96 and 120
Tidsramme: Baseline; 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. |
Baseline; Weeks 96 and 120
|
|
Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120
Tidsramme: Baseline; 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. |
Baseline; Weeks 72, 96, and 120
|
|
Percentage of Participants With HBeAg Loss and Seroconversion at Week 72
Tidsramme: Baseline; 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. |
Baseline; Week 72
|
|
Percentage of Participants With HBeAg Loss and Seroconversion at Week 96
Tidsramme: Baseline; 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. |
Baseline; Week 96
|
|
Percentage of Participants With HBeAg Loss and Seroconversion at Week 120
Tidsramme: Baseline; 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. |
Baseline; Week 120
|
|
Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 72
Tidsramme: 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.
|
Week 72
|
|
Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 96
Tidsramme: 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.
|
Week 96
|
|
Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 120
Tidsramme: 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.
|
Week 120
|
|
Percentage of Participants With Normal ALT at Week 72
Tidsramme: 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. |
Week 72
|
|
Percentage of Participants With Normal ALT at Week 96
Tidsramme: 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. |
Week 96
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Percentage of Participants With Normal ALT at Week 120
Tidsramme: Week 120
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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. |
Week 120
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Percentage of Participants Who Required Retreatment
Tidsramme: Up to 120 weeks
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Participants in the TDF 120 week group were not eligible to enter the retreatment phase and are not presented.
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Up to 120 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Belinda Jump, Gilead Sciences
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- RNA-virusinfektioner
- Virussygdomme
- Infektioner
- Blodbårne infektioner
- Overførbare sygdomme
- Leversygdomme
- Hepatitis, viral, menneskelig
- Hepadnaviridae infektioner
- DNA-virusinfektioner
- Enterovirus infektioner
- Picornaviridae infektioner
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, kronisk
- Hepatitis, kronisk
- Anti-infektionsmidler
- Antivirale midler
- Peginterferon alfa-2a
Andre undersøgelses-id-numre
- GS-US-174-0149
- 2010-024586-45 (EudraCT nummer)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Kronisk hepatitis B
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...Gilead SciencesIkke rekrutterer endnu
-
Mahidol UniversityUkendtKronisk Hepatitis B, HBsAg, Hepatitis B-vaccineThailand
-
Tongji HospitalGilead SciencesRekruttering
-
Changhai HospitalAfsluttet
-
Tam Anh Research InstituteAktiv, ikke rekrutterendeKronisk hepatitis b | Hepatitis Delta med Hepatitis B Carrier StateVietnam
-
Nanfang Hospital of Southern Medical UniversityRekruttering
-
IlDong Pharmaceutical Co LtdRekrutteringKronisk hepatitis bKorea, Republikken
-
Antios Therapeutics, IncAfsluttetKronisk hepatitis bForenede Stater
-
Xi'an Xintong Pharmaceutical Research Co.,Ltd.Ukendt
-
Chong Kun Dang PharmaceuticalAfsluttetKronisk hepatitis bKorea, Republikken
Kliniske forsøg med TDF
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University of North Carolina, Chapel HillNational Institute of Allergy and Infectious Diseases (NIAID)AfsluttetGraviditet | HIV | ForebyggelseMalawi, Zimbabwe
-
Gilead SciencesAfsluttetKronisk hepatitis BTyskland
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development... og andre samarbejdspartnereAfsluttetHypoøstrogenisme | Knogledemineralisering | Subklinisk nyreskade | KnoglemikroarkitekturUganda
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Gilead SciencesAfsluttet
-
Tasly Tianjin Biopharmaceutical Co., Ltd.Ukendt
-
Auritec PharmaceuticalsEunice Kennedy Shriver National Institute of Child Health and Human Development... og andre samarbejdspartnereAfsluttetHuman immundefektvirus (HIV) profylakseForenede Stater
-
Guangzhou 8th People's HospitalRekruttering
-
Jiangsu Hansoh Pharmaceutical Co., Ltd.Afsluttet
-
Yale UniversityAfsluttetHIV-infektionerForenede Stater
-
Peking Union Medical CollegeUkendt