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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

perjantai 15. heinäkuuta 2016 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

751

Vaihe

  • Vaihe 4

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta - 75 vuotta (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: TDF+Peg-IFN 48 Weeks
TDF plus Peg-IFN for 48 weeks
Lääke: TDF
TDF 300 mg tablets administered orally once daily
Muut nimet:
  • Viread®
Lääke: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Muut nimet:
  • Pegasys®
Kokeellinen: TDF 48 Weeks + Peg-IFN 16 Weeks
TDF plus Peg-IFN for 16 weeks, followed by TDF alone for an additional 32 weeks
Lääke: TDF
TDF 300 mg tablets administered orally once daily
Muut nimet:
  • Viread®
Lääke: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Muut nimet:
  • Pegasys®
Active Comparator: TDF 120 Weeks
TDF monotherapy for 120 weeks
Lääke: TDF
TDF 300 mg tablets administered orally once daily
Muut nimet:
  • Viread®
Active Comparator: Peg-IFN 48 Weeks
Peg-IFN monotherapy for 48 weeks
Lääke: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Muut nimet:
  • Pegasys®

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
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
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Gilead Sciences

Tutkijat

  • Opintojohtaja: Belinda Jump, Gilead Sciences

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus

Perjantai 1. huhtikuuta 2011

Ensisijainen valmistuminen (Todellinen)

Perjantai 1. elokuuta 2014

Opintojen valmistuminen (Todellinen)

Keskiviikko 1. heinäkuuta 2015

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Torstai 13. tammikuuta 2011

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 14. tammikuuta 2011

Ensimmäinen Lähetetty (Arvio)

Maanantai 17. tammikuuta 2011

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Arvio)

Perjantai 26. elokuuta 2016

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Perjantai 15. heinäkuuta 2016

Viimeksi vahvistettu

Perjantai 1. heinäkuuta 2016

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

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

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Kliiniset tutkimukset Krooninen hepatiitti B

Kliiniset tutkimukset TDF

Hae vastaavia kokeiluja

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

CROs by country

CROs in Netherlands

Ehdot

Harvinaiset sairaudet

Huumeiden interventiot

Ravintolisät

Sponsori / yhteistyökumppanit

Sijainnit

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