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

15. července 2016 aktualizováno: Gilead Sciences

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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

751

Fáze

  • Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Austrálie
      • Fremantle, Austrálie
        • Fremantle Hospital
      • Nedlands, Austrálie
        • Sir Charles Gairdner Hospital
      • Perth, Austrálie
        • Royal Perth Hospital
    • New South Wales
      • Camperdown, New South Wales, Austrálie
        • Royal Prince Alfred Hospital
      • Concord, New South Wales, Austrálie
        • Concord Repatriation General Hospital
      • Kogarah, New South Wales, Austrálie
        • Saint George's Hospital
      • Liverpool, New South Wales, Austrálie
        • Liverpool Hospital,Gastroenterology Department
      • Westmead, New South Wales, Austrálie
        • Westmead Hospital
    • Queensland
      • Herston, Queensland, Austrálie
        • Royal Brisbane & Women's Hospital
      • Woolloongabba, Queensland, Austrálie
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Austrálie
        • Flinders Medical Center
      • Adelaide SA, South Australia, Austrálie
        • Royal Adelaide Hospital
    • Victoria
      • Clayton, Victoria, Austrálie
        • Monash Medical Centre
      • Fitzroy, Victoria, Austrálie
        • Saint Vincents Hospital
      • Footscray, Victoria, Austrálie
        • Western Hospital
      • Heidelberg, Victoria, Austrálie
        • Austin Health
      • Melbourne, Victoria, Austrálie
        • Alfred Hospital
      • Melbourne, Victoria, Austrálie
        • Box Hill Hospital
      • Parkville, Victoria, Austrálie
        • Royal Melbourne Hospital
  • Francie
      • Paris, Francie
        • Hopital Tenon
      • Rennes Cedex 9, Francie
        • Centre Hospitalier Universitaire de Rennes
      • Rouen, Francie
        • Hopital Charles Nicolle
      • Strasbourg, Francie
        • Centre Hospitalier Regional et Universitaire de Strasbourg, Hopital Civil
      • Toulouse, Francie
        • Centre Hospitalier Universitaire Purpan
      • Villejuif Cedex, Francie
        • Hopital Paul Brousse
    • Cedex
      • Clichy, Cedex, Francie
        • Hôpital Beaujon, Service Hepatologie- Centre Pierre Abrami
      • Lyon, Cedex, Francie
        • Hôpital de la Croix Rousse
  • Holandsko
      • Amsterdam, Holandsko
        • Academisch Medisch Centrum
      • Amsterdam, Holandsko
        • Vrije Universiteit Medisch Centrum
      • Rotterdam, Holandsko
        • Erasmus Medisch Centrum
  • Hongkong
      • Hong Kong, Hongkong
        • Queen Mary Hospital
      • Kowloon, Hongkong
        • Princess Margaret Hospital
      • Shatin, Hongkong
        • Prince of Wales Hospital
      • Tai Po, Hongkong
        • Alice Ho Miu Ling Nethersole Hospital
  • Indie
      • New Delhi, Indie
        • Institute of Liver and Biliary Sciences
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, Indie
        • Global Hospital, Lakdi Ka Pul
    • Assam
      • Guwahati, Assam, Indie
        • Institute of digestive and liver disease, Dispur Hospital Ganeshguri
    • Gujarat
      • Ahmedabad, Gujarat, Indie
        • Vedanta Institute Of Medical Sciences
      • Surat, Gujarat, Indie
        • Liver Clinic
    • Karnataka
      • Bangalore, Karnataka, Indie
        • Manipal Hospitals
    • Maharashtra
      • Mumbai, Maharashtra, Indie
        • Department of Hepatology, Institute of Liver Diseases, HPB Surgery and Transplant, Global Hospital
      • Mumbai, Maharashtra, Indie
        • Seth GS Medical College and KEM Hospital, Acharya Donde Marg,Parel
      • Nagpur, Maharashtra, Indie
        • Midas Institute of Gastroenterology
      • Sangli, Maharashtra, Indie
        • Dharamasi Hospital,Chandni Chowk, South Shivajinagar,
    • New Delhi
      • Delhi, New Delhi, Indie
        • All India Institute of Medical Sciences, Ansari Nagar
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, Indie
        • VGM Hospital
    • West Bengal
      • Kolkata, West Bengal, Indie
        • Institute of Post Graduate Medical Education And Research
  • Itálie
      • Milano, Itálie
        • Ospedale San Raffaele
      • Milano, Itálie
        • Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico
      • Napoli, Itálie
        • Seconda Università degli Studi di Napoli
      • Parma, Itálie
        • Azienda Ospedaliera di Parma,Department of Infectious Diseases and hepatology
      • Roma, Itálie
        • Fondazione PTV - Policlinico Tor Vergata
      • Rome, Itálie
        • Policlinico Umberto I
      • Torino, Itálie
        • University of Milan,Azienda Ospedaliera San Giovanni, Battista di Torino,Dipartimento di Gastroenterologia
    • Cagliari
      • Monserrato, Cagliari, Itálie
        • Azienda Ospedaliero-Universitaria di Cagliari
  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada
        • Heritage Med Research Clinic, Univ of Calgary
      • Zeidler Ledcore Centre, Alberta, Kanada
        • University of Alberta, Zeidler Ledcore Centre
    • British Columbia
      • Vancouver, British Columbia, Kanada
        • Gordon & Leslie Diamond Health Care Centre
      • Vancouver, British Columbia, Kanada
        • Gastrointestional Research Institute
      • Vancouver, British Columbia, Kanada
        • Liver and Intestinal Research Centre
    • Ontario
      • Ottawa, Ontario, Kanada
        • The Ottawa Hospital,Division of Infectious Diseases
      • Toronto, Ontario, Kanada
        • Toronto General Hospital
      • Toronto, Ontario, Kanada
        • Toronto Liver Centre
  • Korejská republika
      • Busan, Korejská republika
        • Inje University Busan Paik Hospital
      • Goyang, Gyeonggi-Do, Korejská republika
        • Inje University Ilsan Paik Hospital
      • Kwangjin-gu, Seoul, Korejská republika
        • Digestive Disease Cntr, Konkuk Univ Hosp
      • Seoul, Korejská republika
        • Seoul National University Hospital
      • Seoul, Korejská republika
        • Asan Medical Center
      • Seoul, Korejská republika
        • Konkuk University Medical Center
      • Seoul, Korejská republika
        • Samsung Medical Center
      • Seoul, Korejská republika
        • Gangnam Severance Hospital
      • Seoul, Korejská republika
        • Seoul Saint Mary's Hospital
    • Chungcheon
      • Cheonan, Chungcheon, Korejská republika
        • SoonChunHyang University Hospital Cheonan
    • Gangwon-do
      • Wonju, Gangwon-do, Korejská republika
        • Yonsei Unversity Wonju College of Medicine Wonju Christian Hospital
    • Gyeonggi-d
      • Ansan-si, Gyeonggi-d, Korejská republika
        • Korea University Ansan Hospital
      • Bucheon, Gyeonggi-d, Korejská republika
        • Bucheon St. Mary's Hospital
      • Seoul, Gyeonggi-d, Korejská republika
        • Korea University Guro Hospital
      • Sungnam, Gyeonggi-d, Korejská republika
        • CHA Bundang Medical Center, CHA University
    • Gyeongsang
      • Busan, Gyeongsang, Korejská republika
        • Pusan National University Hospital
      • Daegu, Gyeongsang, Korejská republika
        • Kyungpook National University Hospital
      • Yangsan, Gyeongsang, Korejská republika
        • Pusan National University Yangsan Hospital
  • Krocan
      • Ankara, Krocan
        • Hacettepe Universitesi Tip Fakultesi
      • Ankara, Krocan
        • Ankara Universitesi Tip Fakultesi
      • Gaziantep, Krocan
        • Gaziantep Üniversitesi Tip Fakültesi, Sahinbey Arastirma ve Uygulama Hastanesi
      • Istanbul, Krocan
        • Istanbul Universitesi Istanbul Tip Fakultesi
      • Mersin, Krocan
        • Mersin Üniversitesi Tip Fakültesi, Saglik Arastirma ve Uygulama Hastanesi
  • Německo
      • Berlin, Německo
        • Charite Berlin
      • Essen, Německo
        • Universitätsklinikum Essen - klinikum für Gastroenterolgie und Hepatologie,
      • Frankfurt, Německo
        • Johann-Wolfgang-Goethe Universitat,
      • Hamburg, Německo
        • Asklepios Westklinikum
      • Hannover, Německo
        • Medizinische Hochschule Hannover,Hastroenterologie und Hepatologie
      • Köln, Německo
        • Universitätsklinik Köln
      • Leipzig, Německo
        • Universitätsklinikum Leipzig
    • Rheinland-pfalz
      • Mainz, Rheinland-pfalz, Německo
        • Johannes Gutenberg-Universitat Mainz,
  • Polsko
      • Bialystok, Polsko
        • Wojewodzki Szpital Specjalistyczny Kazimierza Dluskeigo w Bialymstoku
      • Bydgoszcz, Polsko
        • Wojewódzki Szpital Obserwacyjno Zakazny im. Tadeusza Browicza
      • Krakow, Polsko
        • Szpital Uniwersytecki w Krakowie
      • Lodz, Polsko
        • Wojewódzki Specjalistyczny Szpital im. Dr Wladyslawa Bieganskiego w Lodzi
      • Warszawa, Polsko
        • SP ZOZ Wojewódzki Szpital Zakazny
    • Lodzkie
      • Lodz, Lodzkie, Polsko
        • Wojewódzki Specjalistyczny Szpital im. Dr Wladyslawa Bieganskiego w Lodzi
    • Lubelskie
      • Lublin, Lubelskie, Polsko
        • Samodzielny Publiczny Szpital Kliniczny 1,Klinika Chorób Zakaznych,ulica Staszica 16
    • Slaskie
      • Chorzów, Slaskie, Polsko
        • Szpital Specjalistyczny w Chorzowie
  • Portugalsko
      • Lisboa, Portugalsko
        • Hospital De Santa Maria
      • Lisboa, Portugalsko
        • Hospital de Egas Moniz
      • Porto, Portugalsko
        • Centro Hospitalar do Porto
      • Porto, Portugalsko
        • Hospital Sao Joao
  • Rumunsko
      • Brasov, Rumunsko
        • Neomed Research
      • Bucharest, Rumunsko
        • Spitalul Clinic de Boli Infecțioase și tropicale "Dr. Victor Babeș"
      • Bucharest, Rumunsko
        • Institutul National de Boli Infectioase Prof.Dr. Matei Bals
      • Bucharest, Rumunsko
        • Institutul National De Boli Infectioase "Prof. Dr. Matei Bals"
      • Bucuresti, Rumunsko
        • Spitalul Clinic Colentina
      • Sibiu, Rumunsko
        • Spitalul Clinic Judetean de Urgenta Sibiu
      • Timisoara, Rumunsko
        • Cabinet Particular Policlinic Algomed SRL-Gastroenterologie
  • Singapur
      • Singapore, Singapur
        • Singapore General Hospital
      • Singapore, Singapur
        • Tan Tock Seng Hospital
      • Singapore, Singapur
        • Changi General Hospital
      • Singapore, Singapur
        • National University Hospital Singapore
  • Spojené království
      • Birmingham, WSTMID, Spojené království
        • The Queen Elizabeth Hospital
      • Hampstead,London, Spojené království
        • Royal Free Hospital
      • London, Spojené království
        • King's College Hospital
      • London, Spojené království
        • Barts and The London NHS Trust
  • Spojené státy
    • California
      • Los Angeles, California, Spojené státy
        • Asian Pacific Liver Center
      • Palo Alto, California, Spojené státy
        • Stanford University Medical Center
      • San Diego, California, Spojené státy
        • Research and Education Inc
      • San Jose, California, Spojené státy
        • San Jose Gastroenterology
    • Florida
      • Deland, Florida, Spojené státy
        • Avail Clinical Research, LLC
      • Maitland, Florida, Spojené státy
        • Centre for Advanced Gastroenterology
      • Miami, Florida, Spojené státy
        • University of Miami / Jackson Memorial Medical Center
    • Illinois
      • Chicago, Illinois, Spojené státy
        • University of Chicago
    • Louisiana
      • New Orleans, Louisiana, Spojené státy
        • LSU Gastroenterology/Center for Digestive Diseases
      • New Orleans, Louisiana, Spojené státy
        • Tulane University Hospital and Clinic
    • Maryland
      • Baltimore, Maryland, Spojené státy
        • Digestive Disease Associates
    • Massachusetts
      • Boston, Massachusetts, Spojené státy
        • Tufts Medical Center
    • Michigan
      • Detroit, Michigan, Spojené státy
        • Henry Ford Hospital
    • New Jersey
      • Hillsborough, New Jersey, Spojené státy
        • ID Care, Inc.
    • New York
      • Flushing, New York, Spojené státy
        • Medical Procare, PLLC
      • Great Neck, New York, Spojené státy
        • North Shore University Hospital
      • New York, New York, Spojené státy
        • Beth Israel Medical Center
      • New York, New York, Spojené státy
        • New York Univ. Medical Center
      • New York, New York, Spojené státy
        • Weill Cornell Medical College of Cornell University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Spojené státy
        • Private Practice
    • Texas
      • Houston, Texas, Spojené státy
        • Advanced Liver Therapies at St. Luke's Episcopal Hospital
      • Houston, Texas, Spojené státy
        • Kelsey Research Foundation
      • Houston, Texas, Spojené státy
        • Liver Associates of Texas,
    • Utah
      • Salt Lake City, Utah, Spojené státy
        • University of Utah
    • Virginia
      • Richmond, Virginia, Spojené státy
        • McGuire Research Institute
      • Richmond, Virginia, Spojené státy
        • Liver Institute of Virginia, Bon Secours Health System
  • Tchaj-wan
      • Changhua, Tchaj-wan
        • Changhua Christain Hospital
      • Chia-Yi, Tchaj-wan
        • Chiayi Christian Hosp
      • Hualien, Tchaj-wan
        • Buddhist Tzu Chi General Hospital
      • Kaohsiung, Tchaj-wan
        • Chang Gung Memorial Hospital
      • Kaosiung, Tchaj-wan
        • Kaohsiung Medical University Hospital
      • Keelung Town/KEELUNG CITY, Tchaj-wan
        • Chang Gung Medical Foundation-Keelung
      • Taichung, Tchaj-wan
        • China Medical University Hospital
      • Taichung, Tchaj-wan
        • Chung Shan Medical University Hospital
      • Taichung, Tchaj-wan
        • Taichung Veterans Genl Hosp
      • Tainan, Tchaj-wan
        • National Cheng Kung University Hospital
      • Taipei, Tchaj-wan
        • National Taiwan University Hospital
      • Taipei, Tchaj-wan
        • Cathay General Hospital
    • Banciao Dist
      • New Taipei City, Banciao Dist, Tchaj-wan
        • Far-Eastern Memorial Hosp
    • Taoyuan
      • Tao-Yuan, Taoyuan, Tchaj-wan
        • Chang Gung Medical Foundation.LinKou Branch
  • Řecko
      • Attica, Řecko
        • Ippokratio Hospital Athens
      • Patra, Řecko
        • General University Hospital of Patras
      • Thessaloniki, Řecko
        • Hippokration General Hospital of Thessaloniki
    • Attica
      • Thessaloniki, Attica, Řecko
        • Ippokratio Hospital Salonica
  • Španělsko
      • Barcelona, Španělsko
        • Hospital General Universitari Vall d' Hebron
      • Madrid, Španělsko
        • Hospital Universitario de la Princesa
      • Madrid, Španělsko
        • Hospital Carlos III
      • Malaga, Španělsko
        • Hospital Virgen de la Victoria
      • Sevilla, Španělsko
        • Hospital Universitario Virgen del Rocio
      • Vigo, Pontevedra, Španělsko
        • Hospital Meixoeiro

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 75 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: TDF+Peg-IFN 48 Weeks
TDF plus Peg-IFN for 48 weeks
Lék: TDF
TDF 300 mg tablets administered orally once daily
Ostatní jména:
  • Viread®
Lék: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Ostatní jména:
  • Pegasys®
Experimentální: TDF 48 Weeks + Peg-IFN 16 Weeks
TDF plus Peg-IFN for 16 weeks, followed by TDF alone for an additional 32 weeks
Lék: TDF
TDF 300 mg tablets administered orally once daily
Ostatní jména:
  • Viread®
Lék: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Ostatní jména:
  • Pegasys®
Aktivní komparátor: TDF 120 Weeks
TDF monotherapy for 120 weeks
Lék: TDF
TDF 300 mg tablets administered orally once daily
Ostatní jména:
  • Viread®
Aktivní komparátor: Peg-IFN 48 Weeks
Peg-IFN monotherapy for 48 weeks
Lék: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Ostatní jména:
  • Pegasys®

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Percentage of Participants With Normal ALT at Week 120
Časové okno: Week 120

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
Percentage of Participants Who Required Retreatment
Časové okno: Up to 120 weeks
Participants in the TDF 120 week group were not eligible to enter the retreatment phase and are not presented.
Up to 120 weeks

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Gilead Sciences

Vyšetřovatelé

  • Ředitel studie: Belinda Jump, Gilead Sciences

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. dubna 2011

Primární dokončení (Aktuální)

1. srpna 2014

Dokončení studie (Aktuální)

1. července 2015

Termíny zápisu do studia

První předloženo

13. ledna 2011

První předloženo, které splnilo kritéria kontroly kvality

14. ledna 2011

První zveřejněno (Odhad)

17. ledna 2011

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

26. srpna 2016

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

15. července 2016

Naposledy ověřeno

1. července 2016

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • GS-US-174-0149
  • 2010-024586-45 (Číslo EudraCT)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Chronická hepatitida B

Klinické studie na TDF

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Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

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Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

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