Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

15. Juli 2016 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

751

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Australien
      • Fremantle, Australien
        • Fremantle Hospital
      • Nedlands, Australien
        • Sir Charles Gairdner Hospital
      • Perth, Australien
        • Royal Perth Hospital
    • New South Wales
      • Camperdown, New South Wales, Australien
        • Royal Prince Alfred Hospital
      • Concord, New South Wales, Australien
        • Concord Repatriation General Hospital
      • Kogarah, New South Wales, Australien
        • Saint George's Hospital
      • Liverpool, New South Wales, Australien
        • Liverpool Hospital,Gastroenterology Department
      • Westmead, New South Wales, Australien
        • Westmead Hospital
    • Queensland
      • Herston, Queensland, Australien
        • Royal Brisbane & Women's Hospital
      • Woolloongabba, Queensland, Australien
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australien
        • Flinders Medical Center
      • Adelaide SA, South Australia, Australien
        • Royal Adelaide Hospital
    • Victoria
      • Clayton, Victoria, Australien
        • Monash Medical Centre
      • Fitzroy, Victoria, Australien
        • Saint Vincents Hospital
      • Footscray, Victoria, Australien
        • Western Hospital
      • Heidelberg, Victoria, Australien
        • Austin Health
      • Melbourne, Victoria, Australien
        • Alfred Hospital
      • Melbourne, Victoria, Australien
        • Box Hill Hospital
      • Parkville, Victoria, Australien
        • Royal Melbourne Hospital
  • Deutschland
      • Berlin, Deutschland
        • Charite Berlin
      • Essen, Deutschland
        • Universitätsklinikum Essen - klinikum für Gastroenterolgie und Hepatologie,
      • Frankfurt, Deutschland
        • Johann-Wolfgang-Goethe Universitat,
      • Hamburg, Deutschland
        • Asklepios Westklinikum
      • Hannover, Deutschland
        • Medizinische Hochschule Hannover,Hastroenterologie und Hepatologie
      • Köln, Deutschland
        • Universitätsklinik Köln
      • Leipzig, Deutschland
        • Universitatsklinikum Leipzig
    • Rheinland-pfalz
      • Mainz, Rheinland-pfalz, Deutschland
        • Johannes Gutenberg-Universitat Mainz,
  • Frankreich
      • Paris, Frankreich
        • Hopital Tenon
      • Rennes Cedex 9, Frankreich
        • Centre Hospitalier Universitaire de Rennes
      • Rouen, Frankreich
        • Hopital Charles Nicolle
      • Strasbourg, Frankreich
        • Centre Hospitalier Regional et Universitaire de Strasbourg, Hopital Civil
      • Toulouse, Frankreich
        • Centre Hospitalier Universitaire Purpan
      • Villejuif Cedex, Frankreich
        • Hopital Paul Brousse
    • Cedex
      • Clichy, Cedex, Frankreich
        • Hôpital Beaujon, Service Hepatologie- Centre Pierre Abrami
      • Lyon, Cedex, Frankreich
        • Hôpital de la Croix Rousse
  • Griechenland
      • Attica, Griechenland
        • Ippokratio Hospital Athens
      • Patra, Griechenland
        • General University Hospital of Patras
      • Thessaloniki, Griechenland
        • Hippokration General Hospital of Thessaloniki
    • Attica
      • Thessaloniki, Attica, Griechenland
        • Ippokratio Hospital Salonica
  • 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
  • Indien
      • New Delhi, Indien
        • Institute of Liver and Biliary Sciences
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, Indien
        • Global Hospital, Lakdi Ka Pul
    • Assam
      • Guwahati, Assam, Indien
        • Institute of digestive and liver disease, Dispur Hospital Ganeshguri
    • Gujarat
      • Ahmedabad, Gujarat, Indien
        • Vedanta Institute Of Medical Sciences
      • Surat, Gujarat, Indien
        • Liver Clinic
    • Karnataka
      • Bangalore, Karnataka, Indien
        • Manipal Hospitals
    • Maharashtra
      • Mumbai, Maharashtra, Indien
        • Department of Hepatology, Institute of Liver Diseases, HPB Surgery and Transplant, Global Hospital
      • Mumbai, Maharashtra, Indien
        • Seth GS Medical College and KEM Hospital, Acharya Donde Marg,Parel
      • Nagpur, Maharashtra, Indien
        • Midas Institute of Gastroenterology
      • Sangli, Maharashtra, Indien
        • Dharamasi Hospital,Chandni Chowk, South Shivajinagar,
    • New Delhi
      • Delhi, New Delhi, Indien
        • All India Institute of Medical Sciences, Ansari Nagar
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, Indien
        • VGM Hospital
    • West Bengal
      • Kolkata, West Bengal, Indien
        • Institute of Post Graduate Medical Education And Research
  • Italien
      • Milano, Italien
        • Ospedale San Raffaele
      • Milano, Italien
        • Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico
      • Napoli, Italien
        • Seconda Università degli Studi di Napoli
      • Parma, Italien
        • Azienda Ospedaliera di Parma,Department of Infectious Diseases and hepatology
      • Roma, Italien
        • Fondazione PTV - Policlinico Tor Vergata
      • Rome, Italien
        • Policlinico Umberto I
      • Torino, Italien
        • University of Milan,Azienda Ospedaliera San Giovanni, Battista di Torino,Dipartimento di Gastroenterologia
    • Cagliari
      • Monserrato, Cagliari, Italien
        • 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
  • Korea, Republik von
      • Busan, Korea, Republik von
        • Inje University Busan Paik Hospital
      • Goyang, Gyeonggi-Do, Korea, Republik von
        • Inje University Ilsan Paik Hospital
      • Kwangjin-gu, Seoul, Korea, Republik von
        • Digestive Disease Cntr, Konkuk Univ Hosp
      • Seoul, Korea, Republik von
        • Seoul National University Hospital
      • Seoul, Korea, Republik von
        • Asan Medical Center
      • Seoul, Korea, Republik von
        • Konkuk University Medical Center
      • Seoul, Korea, Republik von
        • Samsung Medical Center
      • Seoul, Korea, Republik von
        • Gangnam Severance Hospital
      • Seoul, Korea, Republik von
        • Seoul Saint Mary's Hospital
    • Chungcheon
      • Cheonan, Chungcheon, Korea, Republik von
        • SoonChunHyang University Hospital Cheonan
    • Gangwon-do
      • Wonju, Gangwon-do, Korea, Republik von
        • Yonsei Unversity Wonju College of Medicine Wonju Christian Hospital
    • Gyeonggi-d
      • Ansan-si, Gyeonggi-d, Korea, Republik von
        • Korea University Ansan Hospital
      • Bucheon, Gyeonggi-d, Korea, Republik von
        • Bucheon St. Mary's Hospital
      • Seoul, Gyeonggi-d, Korea, Republik von
        • Korea University Guro Hospital
      • Sungnam, Gyeonggi-d, Korea, Republik von
        • CHA Bundang Medical Center, CHA University
    • Gyeongsang
      • Busan, Gyeongsang, Korea, Republik von
        • Pusan National University Hospital
      • Daegu, Gyeongsang, Korea, Republik von
        • Kyungpook National University Hospital
      • Yangsan, Gyeongsang, Korea, Republik von
        • Pusan National University Yangsan Hospital
  • Niederlande
      • Amsterdam, Niederlande
        • Academisch Medisch Centrum
      • Amsterdam, Niederlande
        • Vrije Universiteit Medisch Centrum
      • Rotterdam, Niederlande
        • Erasmus Medisch Centrum
  • Polen
      • Bialystok, Polen
        • Wojewodzki Szpital Specjalistyczny Kazimierza Dluskeigo w Bialymstoku
      • Bydgoszcz, Polen
        • Wojewódzki Szpital Obserwacyjno Zakazny im. Tadeusza Browicza
      • Krakow, Polen
        • Szpital Uniwersytecki w Krakowie
      • Lodz, Polen
        • Wojewódzki Specjalistyczny Szpital im. Dr Wladyslawa Bieganskiego w Lodzi
      • Warszawa, Polen
        • SP ZOZ Wojewódzki Szpital Zakazny
    • Lodzkie
      • Lodz, Lodzkie, Polen
        • Wojewódzki Specjalistyczny Szpital im. Dr Wladyslawa Bieganskiego w Lodzi
    • Lubelskie
      • Lublin, Lubelskie, Polen
        • Samodzielny Publiczny Szpital Kliniczny 1,Klinika Chorób Zakaznych,ulica Staszica 16
    • Slaskie
      • Chorzów, Slaskie, Polen
        • Szpital Specjalistyczny w Chorzowie
  • Portugal
      • Lisboa, Portugal
        • Hospital de Santa Maria
      • Lisboa, Portugal
        • Hospital de Egas Moniz
      • Porto, Portugal
        • Centro Hospitalar do Porto
      • Porto, Portugal
        • Hospital Sao Joao
  • Rumänien
      • Brasov, Rumänien
        • Neomed Research
      • Bucharest, Rumänien
        • Spitalul Clinic de Boli Infecțioase și tropicale "Dr. Victor Babeș"
      • Bucharest, Rumänien
        • Institutul National de Boli Infectioase Prof.Dr. Matei Bals
      • Bucharest, Rumänien
        • Institutul National De Boli Infectioase "Prof. Dr. Matei Bals"
      • Bucuresti, Rumänien
        • Spitalul Clinic Colentina
      • Sibiu, Rumänien
        • Spitalul Clinic Judetean de Urgenta Sibiu
      • Timisoara, Rumänien
        • 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
  • Spanien
      • Barcelona, Spanien
        • Hospital General Universitari Vall d' Hebron
      • Madrid, Spanien
        • Hospital Universitario de La Princesa
      • Madrid, Spanien
        • Hospital Carlos III
      • Malaga, Spanien
        • Hospital Virgen de la Victoria
      • Sevilla, Spanien
        • Hospital Universitario Virgen del Rocío
      • Vigo, Pontevedra, Spanien
        • Hospital Meixoeiro
  • 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
  • Truthahn
      • Ankara, Truthahn
        • Hacettepe Universitesi Tip Fakultesi
      • Ankara, Truthahn
        • Ankara Universitesi Tip Fakultesi
      • Gaziantep, Truthahn
        • Gaziantep Üniversitesi Tip Fakültesi, Sahinbey Arastirma ve Uygulama Hastanesi
      • Istanbul, Truthahn
        • Istanbul Universitesi Istanbul Tip Fakultesi
      • Mersin, Truthahn
        • Mersin Üniversitesi Tip Fakültesi, Saglik Arastirma ve Uygulama Hastanesi
  • Vereinigte Staaten
    • California
      • Los Angeles, California, Vereinigte Staaten
        • Asian Pacific Liver Center
      • Palo Alto, California, Vereinigte Staaten
        • Stanford University Medical Center
      • San Diego, California, Vereinigte Staaten
        • Research and Education Inc
      • San Jose, California, Vereinigte Staaten
        • San Jose Gastroenterology
    • Florida
      • Deland, Florida, Vereinigte Staaten
        • Avail Clinical Research, LLC
      • Maitland, Florida, Vereinigte Staaten
        • Centre for Advanced Gastroenterology
      • Miami, Florida, Vereinigte Staaten
        • University of Miami / Jackson Memorial Medical Center
    • Illinois
      • Chicago, Illinois, Vereinigte Staaten
        • University of Chicago
    • Louisiana
      • New Orleans, Louisiana, Vereinigte Staaten
        • LSU Gastroenterology/Center for Digestive Diseases
      • New Orleans, Louisiana, Vereinigte Staaten
        • Tulane University Hospital and Clinic
    • Maryland
      • Baltimore, Maryland, Vereinigte Staaten
        • Digestive Disease Associates
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten
        • Tufts Medical Center
    • Michigan
      • Detroit, Michigan, Vereinigte Staaten
        • Henry Ford Hospital
    • New Jersey
      • Hillsborough, New Jersey, Vereinigte Staaten
        • ID Care, Inc.
    • New York
      • Flushing, New York, Vereinigte Staaten
        • Medical Procare, PLLC
      • Great Neck, New York, Vereinigte Staaten
        • North Shore University Hospital
      • New York, New York, Vereinigte Staaten
        • Beth Israel Medical Center
      • New York, New York, Vereinigte Staaten
        • New York Univ. Medical Center
      • New York, New York, Vereinigte Staaten
        • Weill Cornell Medical College of Cornell University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten
        • Private Practice
    • Texas
      • Houston, Texas, Vereinigte Staaten
        • Advanced Liver Therapies at St. Luke's Episcopal Hospital
      • Houston, Texas, Vereinigte Staaten
        • Kelsey Research Foundation
      • Houston, Texas, Vereinigte Staaten
        • Liver Associates of Texas,
    • Utah
      • Salt Lake City, Utah, Vereinigte Staaten
        • University of Utah
    • Virginia
      • Richmond, Virginia, Vereinigte Staaten
        • McGuire Research Institute
      • Richmond, Virginia, Vereinigte Staaten
        • Liver Institute of Virginia, Bon Secours Health System
  • Vereinigtes Königreich
      • Birmingham, WSTMID, Vereinigtes Königreich
        • The Queen Elizabeth Hospital
      • Hampstead,London, Vereinigtes Königreich
        • Royal Free Hospital
      • London, Vereinigtes Königreich
        • King's College Hospital
      • London, Vereinigtes Königreich
        • Barts and The London NHS Trust

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: TDF+Peg-IFN 48 Weeks
TDF plus Peg-IFN for 48 weeks
Arzneimittel: TDF
TDF 300 mg tablets administered orally once daily
Andere Namen:
  • Viread®
Arzneimittel: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Andere Namen:
  • Pegasys®
Experimental: TDF 48 Weeks + Peg-IFN 16 Weeks
TDF plus Peg-IFN for 16 weeks, followed by TDF alone for an additional 32 weeks
Arzneimittel: TDF
TDF 300 mg tablets administered orally once daily
Andere Namen:
  • Viread®
Arzneimittel: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Andere Namen:
  • Pegasys®
Aktiver Komparator: TDF 120 Weeks
TDF monotherapy for 120 weeks
Arzneimittel: TDF
TDF 300 mg tablets administered orally once daily
Andere Namen:
  • Viread®
Aktiver Komparator: Peg-IFN 48 Weeks
Peg-IFN monotherapy for 48 weeks
Arzneimittel: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Andere Namen:
  • Pegasys®

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Gilead Sciences

Ermittler

  • Studienleiter: Belinda Jump, Gilead Sciences

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. April 2011

Primärer Abschluss (Tatsächlich)

1. August 2014

Studienabschluss (Tatsächlich)

1. Juli 2015

Studienanmeldedaten

Zuerst eingereicht

13. Januar 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. Januar 2011

Zuerst gepostet (Schätzen)

17. Januar 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

26. August 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. Juli 2016

Zuletzt verifiziert

1. Juli 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Chronische Hepatitis B

Klinische Studien zur TDF

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Lebanon

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren