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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 lipca 2016 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

751

Faza

  • Faza 4

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Australia
      • Fremantle, Australia
        • Fremantle Hospital
      • Nedlands, Australia
        • Sir Charles Gairdner Hospital
      • Perth, Australia
        • Royal Perth Hospital
    • New South Wales
      • Camperdown, New South Wales, Australia
        • Royal Prince Alfred Hospital
      • Concord, New South Wales, Australia
        • Concord Repatriation General Hospital
      • Kogarah, New South Wales, Australia
        • Saint George's Hospital
      • Liverpool, New South Wales, Australia
        • Liverpool Hospital,Gastroenterology Department
      • Westmead, New South Wales, Australia
        • Westmead Hospital
    • Queensland
      • Herston, Queensland, Australia
        • Royal Brisbane & Women's Hospital
      • Woolloongabba, Queensland, Australia
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia
        • Flinders Medical Center
      • Adelaide SA, South Australia, Australia
        • Royal Adelaide Hospital
    • Victoria
      • Clayton, Victoria, Australia
        • Monash Medical Centre
      • Fitzroy, Victoria, Australia
        • Saint Vincents Hospital
      • Footscray, Victoria, Australia
        • Western Hospital
      • Heidelberg, Victoria, Australia
        • Austin Health
      • Melbourne, Victoria, Australia
        • Alfred Hospital
      • Melbourne, Victoria, Australia
        • Box Hill Hospital
      • Parkville, Victoria, Australia
        • Royal Melbourne Hospital
  • Francja
      • Paris, Francja
        • Hopital Tenon
      • Rennes Cedex 9, Francja
        • Centre Hospitalier Universitaire de Rennes
      • Rouen, Francja
        • Hopital Charles Nicolle
      • Strasbourg, Francja
        • Centre Hospitalier Regional et Universitaire de Strasbourg, Hopital Civil
      • Toulouse, Francja
        • Centre Hospitalier Universitaire Purpan
      • Villejuif Cedex, Francja
        • Hopital Paul Brousse
    • Cedex
      • Clichy, Cedex, Francja
        • Hôpital Beaujon, Service Hepatologie- Centre Pierre Abrami
      • Lyon, Cedex, Francja
        • Hôpital de la Croix Rousse
  • Grecja
      • Attica, Grecja
        • Ippokratio Hospital Athens
      • Patra, Grecja
        • General University Hospital of Patras
      • Thessaloniki, Grecja
        • Hippokration General Hospital of Thessaloniki
    • Attica
      • Thessaloniki, Attica, Grecja
        • Ippokratio Hospital Salonica
  • Hiszpania
      • Barcelona, Hiszpania
        • Hospital General Universitari Vall d' Hebron
      • Madrid, Hiszpania
        • Hospital Universitario de La Princesa
      • Madrid, Hiszpania
        • Hospital Carlos III
      • Malaga, Hiszpania
        • Hospital Virgen de la Victoria
      • Sevilla, Hiszpania
        • Hospital Universitario Virgen del Rocío
      • Vigo, Pontevedra, Hiszpania
        • Hospital Meixoeiro
  • Holandia
      • Amsterdam, Holandia
        • Academisch Medisch Centrum
      • Amsterdam, Holandia
        • Vrije Universiteit Medisch Centrum
      • Rotterdam, Holandia
        • 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
  • Indyk
      • Ankara, Indyk
        • Hacettepe Universitesi Tip Fakultesi
      • Ankara, Indyk
        • Ankara Universitesi Tip Fakultesi
      • Gaziantep, Indyk
        • Gaziantep Üniversitesi Tip Fakültesi, Sahinbey Arastirma ve Uygulama Hastanesi
      • Istanbul, Indyk
        • Istanbul Universitesi Istanbul Tip Fakultesi
      • Mersin, Indyk
        • Mersin Üniversitesi Tip Fakültesi, Saglik Arastirma ve Uygulama Hastanesi
  • 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
  • Niemcy
      • Berlin, Niemcy
        • Charite Berlin
      • Essen, Niemcy
        • Universitätsklinikum Essen - klinikum für Gastroenterolgie und Hepatologie,
      • Frankfurt, Niemcy
        • Johann-Wolfgang-Goethe Universitat,
      • Hamburg, Niemcy
        • Asklepios Westklinikum
      • Hannover, Niemcy
        • Medizinische Hochschule Hannover,Hastroenterologie und Hepatologie
      • Köln, Niemcy
        • Universitätsklinik Köln
      • Leipzig, Niemcy
        • Universitatsklinikum Leipzig
    • Rheinland-pfalz
      • Mainz, Rheinland-pfalz, Niemcy
        • Johannes Gutenberg-Universitat Mainz,
  • Polska
      • Bialystok, Polska
        • Wojewodzki Szpital Specjalistyczny Kazimierza Dluskeigo w Bialymstoku
      • Bydgoszcz, Polska
        • Wojewódzki Szpital Obserwacyjno Zakazny im. Tadeusza Browicza
      • Krakow, Polska
        • Szpital Uniwersytecki w Krakowie
      • Lodz, Polska
        • Wojewódzki Specjalistyczny Szpital im. Dr Wladyslawa Bieganskiego w Lodzi
      • Warszawa, Polska
        • SP ZOZ Wojewódzki Szpital Zakazny
    • Lodzkie
      • Lodz, Lodzkie, Polska
        • Wojewódzki Specjalistyczny Szpital im. Dr Wladyslawa Bieganskiego w Lodzi
    • Lubelskie
      • Lublin, Lubelskie, Polska
        • Samodzielny Publiczny Szpital Kliniczny 1,Klinika Chorób Zakaznych,ulica Staszica 16
    • Slaskie
      • Chorzów, Slaskie, Polska
        • Szpital Specjalistyczny w Chorzowie
  • Portugalia
      • Lisboa, Portugalia
        • Hospital de Santa Maria
      • Lisboa, Portugalia
        • Hospital de Egas Moniz
      • Porto, Portugalia
        • Centro Hospitalar do Porto
      • Porto, Portugalia
        • Hospital Sao Joao
  • Republika Korei
      • Busan, Republika Korei
        • Inje University Busan Paik Hospital
      • Goyang, Gyeonggi-Do, Republika Korei
        • Inje University Ilsan Paik Hospital
      • Kwangjin-gu, Seoul, Republika Korei
        • Digestive Disease Cntr, Konkuk Univ Hosp
      • Seoul, Republika Korei
        • Seoul National University Hospital
      • Seoul, Republika Korei
        • Asan Medical Center
      • Seoul, Republika Korei
        • Konkuk University Medical Center
      • Seoul, Republika Korei
        • Samsung Medical Center
      • Seoul, Republika Korei
        • Gangnam Severance Hospital
      • Seoul, Republika Korei
        • Seoul Saint Mary's Hospital
    • Chungcheon
      • Cheonan, Chungcheon, Republika Korei
        • SoonChunHyang University Hospital Cheonan
    • Gangwon-do
      • Wonju, Gangwon-do, Republika Korei
        • Yonsei Unversity Wonju College of Medicine Wonju Christian Hospital
    • Gyeonggi-d
      • Ansan-si, Gyeonggi-d, Republika Korei
        • Korea University Ansan Hospital
      • Bucheon, Gyeonggi-d, Republika Korei
        • Bucheon St. Mary's Hospital
      • Seoul, Gyeonggi-d, Republika Korei
        • Korea University Guro Hospital
      • Sungnam, Gyeonggi-d, Republika Korei
        • CHA Bundang Medical Center, CHA University
    • Gyeongsang
      • Busan, Gyeongsang, Republika Korei
        • Pusan National University Hospital
      • Daegu, Gyeongsang, Republika Korei
        • Kyungpook National University Hospital
      • Yangsan, Gyeongsang, Republika Korei
        • Pusan National University Yangsan Hospital
  • Rumunia
      • Brasov, Rumunia
        • Neomed Research
      • Bucharest, Rumunia
        • Spitalul Clinic de Boli Infecțioase și tropicale "Dr. Victor Babeș"
      • Bucharest, Rumunia
        • Institutul National de Boli Infectioase Prof.Dr. Matei Bals
      • Bucharest, Rumunia
        • Institutul National De Boli Infectioase "Prof. Dr. Matei Bals"
      • Bucuresti, Rumunia
        • Spitalul Clinic Colentina
      • Sibiu, Rumunia
        • Spitalul Clinic Judetean de Urgenta Sibiu
      • Timisoara, Rumunia
        • 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
  • Stany Zjednoczone
    • California
      • Los Angeles, California, Stany Zjednoczone
        • Asian Pacific Liver Center
      • Palo Alto, California, Stany Zjednoczone
        • Stanford University Medical Center
      • San Diego, California, Stany Zjednoczone
        • Research and Education Inc
      • San Jose, California, Stany Zjednoczone
        • San Jose Gastroenterology
    • Florida
      • Deland, Florida, Stany Zjednoczone
        • Avail Clinical Research, LLC
      • Maitland, Florida, Stany Zjednoczone
        • Centre for Advanced Gastroenterology
      • Miami, Florida, Stany Zjednoczone
        • University of Miami / Jackson Memorial Medical Center
    • Illinois
      • Chicago, Illinois, Stany Zjednoczone
        • University of Chicago
    • Louisiana
      • New Orleans, Louisiana, Stany Zjednoczone
        • LSU Gastroenterology/Center for Digestive Diseases
      • New Orleans, Louisiana, Stany Zjednoczone
        • Tulane University Hospital and Clinic
    • Maryland
      • Baltimore, Maryland, Stany Zjednoczone
        • Digestive Disease Associates
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone
        • Tufts Medical Center
    • Michigan
      • Detroit, Michigan, Stany Zjednoczone
        • Henry Ford Hospital
    • New Jersey
      • Hillsborough, New Jersey, Stany Zjednoczone
        • ID Care, Inc.
    • New York
      • Flushing, New York, Stany Zjednoczone
        • Medical Procare, PLLC
      • Great Neck, New York, Stany Zjednoczone
        • North Shore University Hospital
      • New York, New York, Stany Zjednoczone
        • Beth Israel Medical Center
      • New York, New York, Stany Zjednoczone
        • New York Univ. Medical Center
      • New York, New York, Stany Zjednoczone
        • Weill Cornell Medical College of Cornell University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stany Zjednoczone
        • Private Practice
    • Texas
      • Houston, Texas, Stany Zjednoczone
        • Advanced Liver Therapies at St. Luke's Episcopal Hospital
      • Houston, Texas, Stany Zjednoczone
        • Kelsey Research Foundation
      • Houston, Texas, Stany Zjednoczone
        • Liver Associates of Texas,
    • Utah
      • Salt Lake City, Utah, Stany Zjednoczone
        • University of Utah
    • Virginia
      • Richmond, Virginia, Stany Zjednoczone
        • McGuire Research Institute
      • Richmond, Virginia, Stany Zjednoczone
        • Liver Institute of Virginia, Bon Secours Health System
  • Tajwan
      • Changhua, Tajwan
        • Changhua Christain Hospital
      • Chia-Yi, Tajwan
        • Chiayi Christian Hosp
      • Hualien, Tajwan
        • Buddhist Tzu Chi General Hospital
      • Kaohsiung, Tajwan
        • Chang Gung Memorial Hospital
      • Kaosiung, Tajwan
        • Kaohsiung Medical University Hospital
      • Keelung Town/KEELUNG CITY, Tajwan
        • Chang Gung Medical Foundation-Keelung
      • Taichung, Tajwan
        • China Medical University Hospital
      • Taichung, Tajwan
        • Chung Shan Medical University Hospital
      • Taichung, Tajwan
        • Taichung Veterans Genl Hosp
      • Tainan, Tajwan
        • National Cheng Kung University Hospital
      • Taipei, Tajwan
        • National Taiwan University Hospital
      • Taipei, Tajwan
        • Cathay General Hospital
    • Banciao Dist
      • New Taipei City, Banciao Dist, Tajwan
        • Far-Eastern Memorial Hosp
    • Taoyuan
      • Tao-Yuan, Taoyuan, Tajwan
        • Chang Gung Medical Foundation.LinKou Branch
  • Włochy
      • Milano, Włochy
        • Ospedale San Raffaele
      • Milano, Włochy
        • Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico
      • Napoli, Włochy
        • Seconda Università degli Studi di Napoli
      • Parma, Włochy
        • Azienda Ospedaliera di Parma,Department of Infectious Diseases and hepatology
      • Roma, Włochy
        • Fondazione PTV - Policlinico Tor Vergata
      • Rome, Włochy
        • Policlinico Umberto I
      • Torino, Włochy
        • University of Milan,Azienda Ospedaliera San Giovanni, Battista di Torino,Dipartimento di Gastroenterologia
    • Cagliari
      • Monserrato, Cagliari, Włochy
        • Azienda Ospedaliero-Universitaria di Cagliari
  • Zjednoczone Królestwo
      • Birmingham, WSTMID, Zjednoczone Królestwo
        • The Queen Elizabeth Hospital
      • Hampstead,London, Zjednoczone Królestwo
        • Royal Free Hospital
      • London, Zjednoczone Królestwo
        • King's College Hospital
      • London, Zjednoczone Królestwo
        • Barts and The London NHS Trust

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 75 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: TDF+Peg-IFN 48 Weeks
TDF plus Peg-IFN for 48 weeks
Lek: TDF
TDF 300 mg tablets administered orally once daily
Inne nazwy:
  • Viread®
Lek: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Inne nazwy:
  • Pegasys®
Eksperymentalny: TDF 48 Weeks + Peg-IFN 16 Weeks
TDF plus Peg-IFN for 16 weeks, followed by TDF alone for an additional 32 weeks
Lek: TDF
TDF 300 mg tablets administered orally once daily
Inne nazwy:
  • Viread®
Lek: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Inne nazwy:
  • Pegasys®
Aktywny komparator: TDF 120 Weeks
TDF monotherapy for 120 weeks
Lek: TDF
TDF 300 mg tablets administered orally once daily
Inne nazwy:
  • Viread®
Aktywny komparator: Peg-IFN 48 Weeks
Peg-IFN monotherapy for 48 weeks
Lek: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Inne nazwy:
  • Pegasys®

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Gilead Sciences

Śledczy

  • Dyrektor Studium: Belinda Jump, Gilead Sciences

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 kwietnia 2011

Zakończenie podstawowe (Rzeczywisty)

1 sierpnia 2014

Ukończenie studiów (Rzeczywisty)

1 lipca 2015

Daty rejestracji na studia

Pierwszy przesłany

13 stycznia 2011

Pierwszy przesłany, który spełnia kryteria kontroli jakości

14 stycznia 2011

Pierwszy wysłany (Oszacować)

17 stycznia 2011

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

26 sierpnia 2016

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

15 lipca 2016

Ostatnia weryfikacja

1 lipca 2016

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

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

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Przewlekłe wirusowe zapalenie wątroby typu B

Badania kliniczne na TDF

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Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Djibouti

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

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Lokalizacje

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