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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 juli 2016 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

751

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Australië
      • Fremantle, Australië
        • Fremantle Hospital
      • Nedlands, Australië
        • Sir Charles Gairdner Hospital
      • Perth, Australië
        • Royal Perth Hospital
    • New South Wales
      • Camperdown, New South Wales, Australië
        • Royal Prince Alfred Hospital
      • Concord, New South Wales, Australië
        • Concord Repatriation General Hospital
      • Kogarah, New South Wales, Australië
        • Saint George's Hospital
      • Liverpool, New South Wales, Australië
        • Liverpool Hospital,Gastroenterology Department
      • Westmead, New South Wales, Australië
        • Westmead Hospital
    • Queensland
      • Herston, Queensland, Australië
        • Royal Brisbane & Women's Hospital
      • Woolloongabba, Queensland, Australië
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australië
        • Flinders Medical Center
      • Adelaide SA, South Australia, Australië
        • Royal Adelaide Hospital
    • Victoria
      • Clayton, Victoria, Australië
        • Monash Medical Centre
      • Fitzroy, Victoria, Australië
        • Saint Vincents Hospital
      • Footscray, Victoria, Australië
        • Western Hospital
      • Heidelberg, Victoria, Australië
        • Austin Health
      • Melbourne, Victoria, Australië
        • Alfred Hospital
      • Melbourne, Victoria, Australië
        • Box Hill Hospital
      • Parkville, Victoria, Australië
        • Royal Melbourne Hospital
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Heritage Med Research Clinic, Univ of Calgary
      • Zeidler Ledcore Centre, Alberta, Canada
        • University of Alberta, Zeidler Ledcore Centre
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Gordon & Leslie Diamond Health Care Centre
      • Vancouver, British Columbia, Canada
        • Gastrointestional Research Institute
      • Vancouver, British Columbia, Canada
        • Liver and Intestinal Research Centre
    • Ontario
      • Ottawa, Ontario, Canada
        • The Ottawa Hospital,Division of Infectious Diseases
      • Toronto, Ontario, Canada
        • Toronto General Hospital
      • Toronto, Ontario, Canada
        • Toronto Liver Centre
  • Duitsland
      • Berlin, Duitsland
        • Charité Berlin
      • Essen, Duitsland
        • Universitätsklinikum Essen - klinikum für Gastroenterolgie und Hepatologie,
      • Frankfurt, Duitsland
        • Johann-Wolfgang-Goethe Universitat,
      • Hamburg, Duitsland
        • Asklepios Westklinikum
      • Hannover, Duitsland
        • Medizinische Hochschule Hannover,Hastroenterologie und Hepatologie
      • Köln, Duitsland
        • Universitätsklinik Köln
      • Leipzig, Duitsland
        • Universitätsklinikum Leipzig
    • Rheinland-pfalz
      • Mainz, Rheinland-pfalz, Duitsland
        • Johannes Gutenberg-Universitat Mainz,
  • Frankrijk
      • Paris, Frankrijk
        • Hôpital Tenon
      • Rennes Cedex 9, Frankrijk
        • Centre Hospitalier Universitaire de Rennes
      • Rouen, Frankrijk
        • Hôpital Charles Nicolle
      • Strasbourg, Frankrijk
        • Centre Hospitalier Regional et Universitaire de Strasbourg, Hopital Civil
      • Toulouse, Frankrijk
        • Centre Hospitalier Universitaire Purpan
      • Villejuif Cedex, Frankrijk
        • Hôpital Paul Brousse
    • Cedex
      • Clichy, Cedex, Frankrijk
        • Hôpital Beaujon, Service Hepatologie- Centre Pierre Abrami
      • Lyon, Cedex, Frankrijk
        • Hôpital de la Croix Rousse
  • Griekenland
      • Attica, Griekenland
        • Ippokratio Hospital Athens
      • Patra, Griekenland
        • General University Hospital of Patras
      • Thessaloniki, Griekenland
        • Hippokration General Hospital of Thessaloniki
    • Attica
      • Thessaloniki, Attica, Griekenland
        • 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
  • Indië
      • New Delhi, Indië
        • Institute of liver and Biliary Sciences
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, Indië
        • Global Hospital, Lakdi Ka Pul
    • Assam
      • Guwahati, Assam, Indië
        • Institute of digestive and liver disease, Dispur Hospital Ganeshguri
    • Gujarat
      • Ahmedabad, Gujarat, Indië
        • Vedanta Institute Of Medical Sciences
      • Surat, Gujarat, Indië
        • Liver Clinic
    • Karnataka
      • Bangalore, Karnataka, Indië
        • Manipal Hospitals
    • Maharashtra
      • Mumbai, Maharashtra, Indië
        • Department of Hepatology, Institute of Liver Diseases, HPB Surgery and Transplant, Global Hospital
      • Mumbai, Maharashtra, Indië
        • Seth GS Medical College and KEM Hospital, Acharya Donde Marg,Parel
      • Nagpur, Maharashtra, Indië
        • Midas Institute of Gastroenterology
      • Sangli, Maharashtra, Indië
        • Dharamasi Hospital,Chandni Chowk, South Shivajinagar,
    • New Delhi
      • Delhi, New Delhi, Indië
        • All India Institute of Medical Sciences, Ansari Nagar
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, Indië
        • VGM Hospital
    • West Bengal
      • Kolkata, West Bengal, Indië
        • Institute of Post Graduate Medical Education And Research
  • Italië
      • Milano, Italië
        • Ospedale San Raffaele
      • Milano, Italië
        • Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico
      • Napoli, Italië
        • Seconda Università degli Studi di Napoli
      • Parma, Italië
        • Azienda Ospedaliera di Parma,Department of Infectious Diseases and hepatology
      • Roma, Italië
        • Fondazione PTV - Policlinico Tor Vergata
      • Rome, Italië
        • Policlinico Umberto I
      • Torino, Italië
        • University of Milan,Azienda Ospedaliera San Giovanni, Battista di Torino,Dipartimento di Gastroenterologia
    • Cagliari
      • Monserrato, Cagliari, Italië
        • Azienda Ospedaliero-Universitaria di Cagliari
  • Kalkoen
      • Ankara, Kalkoen
        • Hacettepe Universitesi Tip Fakultesi
      • Ankara, Kalkoen
        • Ankara Universitesi Tip Fakultesi
      • Gaziantep, Kalkoen
        • Gaziantep Üniversitesi Tip Fakültesi, Sahinbey Arastirma ve Uygulama Hastanesi
      • Istanbul, Kalkoen
        • Istanbul Universitesi Istanbul Tip Fakultesi
      • Mersin, Kalkoen
        • Mersin Üniversitesi Tip Fakültesi, Saglik Arastirma ve Uygulama Hastanesi
  • Korea, republiek van
      • Busan, Korea, republiek van
        • Inje University Busan Paik Hospital
      • Goyang, Gyeonggi-Do, Korea, republiek van
        • Inje University Ilsan Paik Hospital
      • Kwangjin-gu, Seoul, Korea, republiek van
        • Digestive Disease Cntr, Konkuk Univ Hosp
      • Seoul, Korea, republiek van
        • Seoul National University Hospital
      • Seoul, Korea, republiek van
        • Asan Medical Center
      • Seoul, Korea, republiek van
        • Konkuk University Medical Center
      • Seoul, Korea, republiek van
        • Samsung Medical Center
      • Seoul, Korea, republiek van
        • Gangnam Severance Hospital
      • Seoul, Korea, republiek van
        • Seoul Saint Mary's Hospital
    • Chungcheon
      • Cheonan, Chungcheon, Korea, republiek van
        • SoonChunHyang University Hospital Cheonan
    • Gangwon-do
      • Wonju, Gangwon-do, Korea, republiek van
        • Yonsei Unversity Wonju College of Medicine Wonju Christian Hospital
    • Gyeonggi-d
      • Ansan-si, Gyeonggi-d, Korea, republiek van
        • Korea University Ansan Hospital
      • Bucheon, Gyeonggi-d, Korea, republiek van
        • Bucheon St. Mary's Hospital
      • Seoul, Gyeonggi-d, Korea, republiek van
        • Korea University Guro Hospital
      • Sungnam, Gyeonggi-d, Korea, republiek van
        • CHA Bundang Medical Center, CHA University
    • Gyeongsang
      • Busan, Gyeongsang, Korea, republiek van
        • Pusan National University Hospital
      • Daegu, Gyeongsang, Korea, republiek van
        • Kyungpook National University Hospital
      • Yangsan, Gyeongsang, Korea, republiek van
        • Pusan National University Yangsan Hospital
  • Nederland
      • Amsterdam, Nederland
        • Academisch Medisch Centrum
      • Amsterdam, Nederland
        • Vrije Universiteit Medisch Centrum
      • Rotterdam, Nederland
        • 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
  • Roemenië
      • Brasov, Roemenië
        • Neomed Research
      • Bucharest, Roemenië
        • Spitalul Clinic de Boli Infecțioase și tropicale "Dr. Victor Babeș"
      • Bucharest, Roemenië
        • Institutul National de Boli Infectioase Prof.Dr. Matei Bals
      • Bucharest, Roemenië
        • Institutul National De Boli Infectioase "Prof. Dr. Matei Bals"
      • Bucuresti, Roemenië
        • Spitalul Clinic Colentina
      • Sibiu, Roemenië
        • Spitalul Clinic Judetean de Urgenta Sibiu
      • Timisoara, Roemenië
        • Cabinet Particular Policlinic Algomed SRL-Gastroenterologie
  • Singapore
      • Singapore, Singapore
        • Singapore General Hospital
      • Singapore, Singapore
        • Tan Tock Seng Hospital
      • Singapore, Singapore
        • Changi General Hospital
      • Singapore, Singapore
        • National University Hospital Singapore
  • Spanje
      • Barcelona, Spanje
        • Hospital General Universitari Vall d' Hebron
      • Madrid, Spanje
        • Hospital Universitario de la Princesa
      • Madrid, Spanje
        • Hospital Carlos III
      • Malaga, Spanje
        • Hospital Virgen de la Victoria
      • Sevilla, Spanje
        • Hospital Universitario Virgen Del Rocio
      • Vigo, Pontevedra, Spanje
        • 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
  • Verenigd Koninkrijk
      • Birmingham, WSTMID, Verenigd Koninkrijk
        • The Queen Elizabeth Hospital
      • Hampstead,London, Verenigd Koninkrijk
        • Royal Free Hospital
      • London, Verenigd Koninkrijk
        • King's College Hospital
      • London, Verenigd Koninkrijk
        • Barts and the London NHS Trust
  • Verenigde Staten
    • California
      • Los Angeles, California, Verenigde Staten
        • Asian Pacific Liver Center
      • Palo Alto, California, Verenigde Staten
        • Stanford University Medical Center
      • San Diego, California, Verenigde Staten
        • Research and Education Inc
      • San Jose, California, Verenigde Staten
        • San Jose Gastroenterology
    • Florida
      • Deland, Florida, Verenigde Staten
        • Avail Clinical Research, LLC
      • Maitland, Florida, Verenigde Staten
        • Centre for Advanced Gastroenterology
      • Miami, Florida, Verenigde Staten
        • University of Miami / Jackson Memorial Medical Center
    • Illinois
      • Chicago, Illinois, Verenigde Staten
        • University of Chicago
    • Louisiana
      • New Orleans, Louisiana, Verenigde Staten
        • LSU Gastroenterology/Center for Digestive Diseases
      • New Orleans, Louisiana, Verenigde Staten
        • Tulane University Hospital and Clinic
    • Maryland
      • Baltimore, Maryland, Verenigde Staten
        • Digestive Disease Associates
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten
        • Tufts Medical Center
    • Michigan
      • Detroit, Michigan, Verenigde Staten
        • Henry Ford Hospital
    • New Jersey
      • Hillsborough, New Jersey, Verenigde Staten
        • ID Care, Inc.
    • New York
      • Flushing, New York, Verenigde Staten
        • Medical Procare, PLLC
      • Great Neck, New York, Verenigde Staten
        • North Shore University Hospital
      • New York, New York, Verenigde Staten
        • Beth Israel Medical Center
      • New York, New York, Verenigde Staten
        • New York Univ. Medical Center
      • New York, New York, Verenigde Staten
        • Weill Cornell Medical College of Cornell University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten
        • Private practice
    • Texas
      • Houston, Texas, Verenigde Staten
        • Advanced Liver Therapies at St. Luke's Episcopal Hospital
      • Houston, Texas, Verenigde Staten
        • Kelsey Research Foundation
      • Houston, Texas, Verenigde Staten
        • Liver Associates of Texas,
    • Utah
      • Salt Lake City, Utah, Verenigde Staten
        • University of Utah
    • Virginia
      • Richmond, Virginia, Verenigde Staten
        • McGuire Research Institute
      • Richmond, Virginia, Verenigde Staten
        • Liver Institute of Virginia, Bon Secours Health System

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: TDF+Peg-IFN 48 Weeks
TDF plus Peg-IFN for 48 weeks
Geneesmiddel: TDF
TDF 300 mg tablets administered orally once daily
Andere namen:
  • Viread®
Geneesmiddel: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Andere namen:
  • Pegasys®
Experimenteel: TDF 48 Weeks + Peg-IFN 16 Weeks
TDF plus Peg-IFN for 16 weeks, followed by TDF alone for an additional 32 weeks
Geneesmiddel: TDF
TDF 300 mg tablets administered orally once daily
Andere namen:
  • Viread®
Geneesmiddel: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Andere namen:
  • Pegasys®
Actieve vergelijker: TDF 120 Weeks
TDF monotherapy for 120 weeks
Geneesmiddel: TDF
TDF 300 mg tablets administered orally once daily
Andere namen:
  • Viread®
Actieve vergelijker: Peg-IFN 48 Weeks
Peg-IFN monotherapy for 48 weeks
Geneesmiddel: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Andere namen:
  • Pegasys®

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Gilead Sciences

Onderzoekers

  • Studie directeur: Belinda Jump, Gilead Sciences

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2011

Primaire voltooiing (Werkelijk)

1 augustus 2014

Studie voltooiing (Werkelijk)

1 juli 2015

Studieregistratiedata

Eerst ingediend

13 januari 2011

Eerst ingediend dat voldeed aan de QC-criteria

14 januari 2011

Eerst geplaatst (Schatting)

17 januari 2011

Updates van studierecords

Laatste update geplaatst (Schatting)

26 augustus 2016

Laatste update ingediend die voldeed aan QC-criteria

15 juli 2016

Laatst geverifieerd

1 juli 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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