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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 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

751

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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
  • Frankrike
      • Paris, Frankrike
        • Hopital Tenon
      • Rennes Cedex 9, Frankrike
        • Centre hospitalier universitaire de Rennes
      • Rouen, Frankrike
        • Hopital Charles Nicolle
      • Strasbourg, Frankrike
        • Centre Hospitalier Regional et Universitaire de Strasbourg, Hopital Civil
      • Toulouse, Frankrike
        • Centre Hospitalier Universitaire Purpan
      • Villejuif Cedex, Frankrike
        • Hopital Paul Brousse
    • Cedex
      • Clichy, Cedex, Frankrike
        • Hôpital Beaujon, Service Hepatologie- Centre Pierre Abrami
      • Lyon, Cedex, Frankrike
        • Hôpital de La Croix Rousse
  • Förenta staterna
    • California
      • Los Angeles, California, Förenta staterna
        • Asian Pacific Liver Center
      • Palo Alto, California, Förenta staterna
        • Stanford University Medical Center
      • San Diego, California, Förenta staterna
        • Research and Education Inc
      • San Jose, California, Förenta staterna
        • San Jose Gastroenterology
    • Florida
      • Deland, Florida, Förenta staterna
        • Avail Clinical Research, LLC
      • Maitland, Florida, Förenta staterna
        • Centre for Advanced Gastroenterology
      • Miami, Florida, Förenta staterna
        • University of Miami / Jackson Memorial Medical Center
    • Illinois
      • Chicago, Illinois, Förenta staterna
        • University of Chicago
    • Louisiana
      • New Orleans, Louisiana, Förenta staterna
        • LSU Gastroenterology/Center for Digestive Diseases
      • New Orleans, Louisiana, Förenta staterna
        • Tulane University Hospital and Clinic
    • Maryland
      • Baltimore, Maryland, Förenta staterna
        • Digestive Disease Associates
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna
        • Tufts Medical Center
    • Michigan
      • Detroit, Michigan, Förenta staterna
        • Henry Ford Hospital
    • New Jersey
      • Hillsborough, New Jersey, Förenta staterna
        • ID Care, Inc.
    • New York
      • Flushing, New York, Förenta staterna
        • Medical Procare, PLLC
      • Great Neck, New York, Förenta staterna
        • North Shore University Hospital
      • New York, New York, Förenta staterna
        • Beth Israel Medical Center
      • New York, New York, Förenta staterna
        • New York Univ. Medical Center
      • New York, New York, Förenta staterna
        • Weill Cornell Medical College of Cornell University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna
        • Private Practice
    • Texas
      • Houston, Texas, Förenta staterna
        • Advanced Liver Therapies at St. Luke's Episcopal Hospital
      • Houston, Texas, Förenta staterna
        • Kelsey Research Foundation
      • Houston, Texas, Förenta staterna
        • Liver Associates of Texas,
    • Utah
      • Salt Lake City, Utah, Förenta staterna
        • University of Utah
    • Virginia
      • Richmond, Virginia, Förenta staterna
        • McGuire Research Institute
      • Richmond, Virginia, Förenta staterna
        • Liver Institute of Virginia, Bon Secours Health System
  • Grekland
      • Attica, Grekland
        • Ippokratio Hospital Athens
      • Patra, Grekland
        • General University Hospital of Patras
      • Thessaloniki, Grekland
        • Hippokration General Hospital of Thessaloniki
    • Attica
      • Thessaloniki, Attica, Grekland
        • Ippokratio Hospital Salonica
  • 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
  • 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 Ca 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
  • Kalkon
      • Ankara, Kalkon
        • Hacettepe Universitesi Tip Fakultesi
      • Ankara, Kalkon
        • Ankara Universitesi Tip Fakultesi
      • Gaziantep, Kalkon
        • Gaziantep Üniversitesi Tip Fakültesi, Sahinbey Arastirma ve Uygulama Hastanesi
      • Istanbul, Kalkon
        • Istanbul Universitesi Istanbul Tip Fakultesi
      • Mersin, Kalkon
        • 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
  • Korea, Republiken av
      • Busan, Korea, Republiken av
        • Inje University Busan Paik Hospital
      • Goyang, Gyeonggi-Do, Korea, Republiken av
        • Inje University Ilsan Paik Hospital
      • Kwangjin-gu, Seoul, Korea, Republiken av
        • Digestive Disease Cntr, Konkuk Univ Hosp
      • Seoul, Korea, Republiken av
        • Seoul National University Hospital
      • Seoul, Korea, Republiken av
        • Asan Medical Center
      • Seoul, Korea, Republiken av
        • Konkuk University Medical Center
      • Seoul, Korea, Republiken av
        • Samsung Medical Center
      • Seoul, Korea, Republiken av
        • Gangnam Severance Hospital
      • Seoul, Korea, Republiken av
        • Seoul Saint Mary's Hospital
    • Chungcheon
      • Cheonan, Chungcheon, Korea, Republiken av
        • Soonchunhyang University Hospital Cheonan
    • Gangwon-do
      • Wonju, Gangwon-do, Korea, Republiken av
        • Yonsei Unversity Wonju College of Medicine Wonju Christian Hospital
    • Gyeonggi-d
      • Ansan-si, Gyeonggi-d, Korea, Republiken av
        • Korea University Ansan Hospital
      • Bucheon, Gyeonggi-d, Korea, Republiken av
        • Bucheon St. Mary's Hospital
      • Seoul, Gyeonggi-d, Korea, Republiken av
        • Korea University Guro Hospital
      • Sungnam, Gyeonggi-d, Korea, Republiken av
        • CHA Bundang Medical Center, CHA University
    • Gyeongsang
      • Busan, Gyeongsang, Korea, Republiken av
        • Pusan National University Hospital
      • Daegu, Gyeongsang, Korea, Republiken av
        • Kyungpook National University Hospital
      • Yangsan, Gyeongsang, Korea, Republiken av
        • Pusan National University Yangsan Hospital
  • Nederländerna
      • Amsterdam, Nederländerna
        • Academisch Medisch Centrum
      • Amsterdam, Nederländerna
        • Vrije Universiteit Medisch Centrum
      • Rotterdam, Nederländerna
        • 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 Infectioase si Tropicale "Dr. Victor Babes"
      • 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
  • Singapore
      • Singapore, Singapore
        • Singapore General Hospital
      • Singapore, Singapore
        • Tan Tock Seng Hospital
      • Singapore, Singapore
        • Changi General Hospital
      • Singapore, Singapore
        • 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 Rocio
      • Vigo, Pontevedra, Spanien
        • Hospital Meixoeiro
  • Storbritannien
      • Birmingham, WSTMID, Storbritannien
        • The Queen Elizabeth Hospital
      • Hampstead,London, Storbritannien
        • Royal Free Hospital
      • London, Storbritannien
        • King's College Hospital
      • London, Storbritannien
        • Barts and the London NHS Trust
  • 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
  • Tyskland
      • Berlin, Tyskland
        • Charite Berlin
      • Essen, Tyskland
        • Universitätsklinikum Essen - klinikum für Gastroenterolgie und Hepatologie,
      • Frankfurt, Tyskland
        • Johann-Wolfgang-Goethe Universitat,
      • Hamburg, Tyskland
        • Asklepios Westklinikum
      • Hannover, Tyskland
        • Medizinische Hochschule Hannover,Hastroenterologie und Hepatologie
      • Köln, Tyskland
        • Universitätsklinik Köln
      • Leipzig, Tyskland
        • Universitatsklinikum Leipzig
    • Rheinland-pfalz
      • Mainz, Rheinland-pfalz, Tyskland
        • Johannes Gutenberg-Universitat Mainz,

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: TDF+Peg-IFN 48 Weeks
TDF plus Peg-IFN for 48 weeks
Läkemedel: TDF
TDF 300 mg tablets administered orally once daily
Andra namn:
  • Viread®
Läkemedel: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Andra namn:
  • Pegasys®
Experimentell: TDF 48 Weeks + Peg-IFN 16 Weeks
TDF plus Peg-IFN for 16 weeks, followed by TDF alone for an additional 32 weeks
Läkemedel: TDF
TDF 300 mg tablets administered orally once daily
Andra namn:
  • Viread®
Läkemedel: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Andra namn:
  • Pegasys®
Aktiv komparator: TDF 120 Weeks
TDF monotherapy for 120 weeks
Läkemedel: TDF
TDF 300 mg tablets administered orally once daily
Andra namn:
  • Viread®
Aktiv komparator: Peg-IFN 48 Weeks
Peg-IFN monotherapy for 48 weeks
Läkemedel: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Andra namn:
  • Pegasys®

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Gilead Sciences

Utredare

  • Studierektor: Belinda Jump, Gilead Sciences

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2011

Primärt slutförande (Faktisk)

1 augusti 2014

Avslutad studie (Faktisk)

1 juli 2015

Studieregistreringsdatum

Först inskickad

13 januari 2011

Först inskickad som uppfyllde QC-kriterierna

14 januari 2011

Första postat (Uppskatta)

17 januari 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

26 augusti 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 juli 2016

Senast verifierad

1 juli 2016

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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