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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 luglio 2016 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

751

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • 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
  • 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
  • Corea, Repubblica di
      • Busan, Corea, Repubblica di
        • Inje University Busan Paik Hospital
      • Goyang, Gyeonggi-Do, Corea, Repubblica di
        • Inje University Ilsan Paik Hospital
      • Kwangjin-gu, Seoul, Corea, Repubblica di
        • Digestive Disease Cntr, Konkuk Univ Hosp
      • Seoul, Corea, Repubblica di
        • Seoul National University Hospital
      • Seoul, Corea, Repubblica di
        • Asan Medical Center
      • Seoul, Corea, Repubblica di
        • Konkuk University Medical Center
      • Seoul, Corea, Repubblica di
        • Samsung Medical Center
      • Seoul, Corea, Repubblica di
        • Gangnam Severance Hospital
      • Seoul, Corea, Repubblica di
        • Seoul Saint Mary's Hospital
    • Chungcheon
      • Cheonan, Chungcheon, Corea, Repubblica di
        • SoonChunHyang University Hospital Cheonan
    • Gangwon-do
      • Wonju, Gangwon-do, Corea, Repubblica di
        • Yonsei Unversity Wonju College of Medicine Wonju Christian Hospital
    • Gyeonggi-d
      • Ansan-si, Gyeonggi-d, Corea, Repubblica di
        • Korea University Ansan Hospital
      • Bucheon, Gyeonggi-d, Corea, Repubblica di
        • Bucheon St. Mary's Hospital
      • Seoul, Gyeonggi-d, Corea, Repubblica di
        • Korea University Guro Hospital
      • Sungnam, Gyeonggi-d, Corea, Repubblica di
        • CHA Bundang Medical Center, CHA University
    • Gyeongsang
      • Busan, Gyeongsang, Corea, Repubblica di
        • Pusan National University Hospital
      • Daegu, Gyeongsang, Corea, Repubblica di
        • Kyungpook National University Hospital
      • Yangsan, Gyeongsang, Corea, Repubblica di
        • Pusan National University Yangsan Hospital
  • Francia
      • Paris, Francia
        • Hopital Tenon
      • Rennes Cedex 9, Francia
        • Centre Hospitalier Universitaire de Rennes
      • Rouen, Francia
        • Hopital Charles Nicolle
      • Strasbourg, Francia
        • Centre Hospitalier Regional et Universitaire de Strasbourg, Hopital Civil
      • Toulouse, Francia
        • Centre Hospitalier Universitaire Purpan
      • Villejuif Cedex, Francia
        • Hopital Paul Brousse
    • Cedex
      • Clichy, Cedex, Francia
        • Hôpital Beaujon, Service Hepatologie- Centre Pierre Abrami
      • Lyon, Cedex, Francia
        • Hôpital de la Croix Rousse
  • Germania
      • Berlin, Germania
        • Charite Berlin
      • Essen, Germania
        • Universitätsklinikum Essen - klinikum für Gastroenterolgie und Hepatologie,
      • Frankfurt, Germania
        • Johann-Wolfgang-Goethe Universitat,
      • Hamburg, Germania
        • Asklepios Westklinikum
      • Hannover, Germania
        • Medizinische Hochschule Hannover,Hastroenterologie und Hepatologie
      • Köln, Germania
        • Universitätsklinik Köln
      • Leipzig, Germania
        • Universitätsklinikum Leipzig
    • Rheinland-pfalz
      • Mainz, Rheinland-pfalz, Germania
        • Johannes Gutenberg-Universitat Mainz,
  • Grecia
      • Attica, Grecia
        • Ippokratio Hospital Athens
      • Patra, Grecia
        • General University Hospital of Patras
      • Thessaloniki, Grecia
        • Hippokration General Hospital of Thessaloniki
    • Attica
      • Thessaloniki, Attica, Grecia
        • 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
  • India
      • New Delhi, India
        • Institute of Liver and Biliary Sciences
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India
        • Global Hospital, Lakdi Ka Pul
    • Assam
      • Guwahati, Assam, India
        • Institute of digestive and liver disease, Dispur Hospital Ganeshguri
    • Gujarat
      • Ahmedabad, Gujarat, India
        • Vedanta Institute Of Medical Sciences
      • Surat, Gujarat, India
        • Liver Clinic
    • Karnataka
      • Bangalore, Karnataka, India
        • Manipal Hospitals
    • Maharashtra
      • Mumbai, Maharashtra, India
        • Department of Hepatology, Institute of Liver Diseases, HPB Surgery and Transplant, Global Hospital
      • Mumbai, Maharashtra, India
        • Seth GS Medical College and KEM Hospital, Acharya Donde Marg,Parel
      • Nagpur, Maharashtra, India
        • Midas Institute of Gastroenterology
      • Sangli, Maharashtra, India
        • Dharamasi Hospital,Chandni Chowk, South Shivajinagar,
    • New Delhi
      • Delhi, New Delhi, India
        • All India Institute of Medical Sciences, Ansari Nagar
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India
        • VGM Hospital
    • West Bengal
      • Kolkata, West Bengal, India
        • Institute of Post Graduate Medical Education And Research
  • Italia
      • Milano, Italia
        • Ospedale San Raffaele
      • Milano, Italia
        • Fondazione IRCCS Cà 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
  • Olanda
      • Amsterdam, Olanda
        • Academisch Medisch Centrum
      • Amsterdam, Olanda
        • Vrije Universiteit Medisch Centrum
      • Rotterdam, Olanda
        • Erasmus Medisch Centrum
  • Polonia
      • Bialystok, Polonia
        • Wojewodzki Szpital Specjalistyczny Kazimierza Dluskeigo w Bialymstoku
      • Bydgoszcz, Polonia
        • Wojewódzki Szpital Obserwacyjno Zakazny im. Tadeusza Browicza
      • Krakow, Polonia
        • Szpital Uniwersytecki w Krakowie
      • Lodz, Polonia
        • Wojewódzki Specjalistyczny Szpital im. Dr Wladyslawa Bieganskiego w Lodzi
      • Warszawa, Polonia
        • SP ZOZ Wojewódzki Szpital Zakazny
    • Lodzkie
      • Lodz, Lodzkie, Polonia
        • Wojewódzki Specjalistyczny Szpital im. Dr Wladyslawa Bieganskiego w Lodzi
    • Lubelskie
      • Lublin, Lubelskie, Polonia
        • Samodzielny Publiczny Szpital Kliniczny 1,Klinika Chorób Zakaznych,ulica Staszica 16
    • Slaskie
      • Chorzów, Slaskie, Polonia
        • Szpital Specjalistyczny w Chorzowie
  • Portogallo
      • Lisboa, Portogallo
        • Hospital De Santa Maria
      • Lisboa, Portogallo
        • Hospital de Egas Moniz
      • Porto, Portogallo
        • Centro Hospitalar do Porto
      • Porto, Portogallo
        • Hospital Sao Joao
  • Regno Unito
      • Birmingham, WSTMID, Regno Unito
        • The Queen Elizabeth Hospital
      • Hampstead,London, Regno Unito
        • Royal Free Hospital
      • London, Regno Unito
        • King's College Hospital
      • London, Regno Unito
        • Barts and The London NHS Trust
  • Romania
      • Brasov, Romania
        • Neomed Research
      • Bucharest, Romania
        • Spitalul Clinic de Boli Infecțioase și tropicale "Dr. Victor Babeș"
      • 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
  • Singapore
      • Singapore, Singapore
        • Singapore General Hospital
      • Singapore, Singapore
        • Tan Tock Seng Hospital
      • Singapore, Singapore
        • Changi General Hospital
      • Singapore, Singapore
        • National University Hospital Singapore
  • Spagna
      • Barcelona, Spagna
        • Hospital General Universitari Vall d' Hebron
      • Madrid, Spagna
        • Hospital Universitario de la Princesa
      • Madrid, Spagna
        • Hospital Carlos III
      • Malaga, Spagna
        • Hospital Virgen de la Victoria
      • Sevilla, Spagna
        • Hospital Universitario Virgen del Rocio
      • Vigo, Pontevedra, Spagna
        • Hospital Meixoeiro
  • Stati Uniti
    • California
      • Los Angeles, California, Stati Uniti
        • Asian Pacific Liver Center
      • Palo Alto, California, Stati Uniti
        • Stanford University Medical Center
      • San Diego, California, Stati Uniti
        • Research and Education Inc
      • San Jose, California, Stati Uniti
        • San Jose Gastroenterology
    • Florida
      • Deland, Florida, Stati Uniti
        • Avail Clinical Research, LLC
      • Maitland, Florida, Stati Uniti
        • Centre for Advanced Gastroenterology
      • Miami, Florida, Stati Uniti
        • University of Miami / Jackson Memorial Medical Center
    • Illinois
      • Chicago, Illinois, Stati Uniti
        • University of Chicago
    • Louisiana
      • New Orleans, Louisiana, Stati Uniti
        • LSU Gastroenterology/Center for Digestive Diseases
      • New Orleans, Louisiana, Stati Uniti
        • Tulane University Hospital and Clinic
    • Maryland
      • Baltimore, Maryland, Stati Uniti
        • Digestive Disease Associates
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti
        • Tufts Medical Center
    • Michigan
      • Detroit, Michigan, Stati Uniti
        • Henry Ford Hospital
    • New Jersey
      • Hillsborough, New Jersey, Stati Uniti
        • ID Care, Inc.
    • New York
      • Flushing, New York, Stati Uniti
        • Medical Procare, PLLC
      • Great Neck, New York, Stati Uniti
        • North Shore University Hospital
      • New York, New York, Stati Uniti
        • Beth Israel Medical Center
      • New York, New York, Stati Uniti
        • New York Univ. Medical Center
      • New York, New York, Stati Uniti
        • Weill Cornell Medical College of Cornell University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti
        • Private Practice
    • Texas
      • Houston, Texas, Stati Uniti
        • Advanced Liver Therapies at St. Luke's Episcopal Hospital
      • Houston, Texas, Stati Uniti
        • Kelsey Research Foundation
      • Houston, Texas, Stati Uniti
        • Liver Associates of Texas,
    • Utah
      • Salt Lake City, Utah, Stati Uniti
        • University of Utah
    • Virginia
      • Richmond, Virginia, Stati Uniti
        • McGuire Research Institute
      • Richmond, Virginia, Stati Uniti
        • Liver Institute of Virginia, Bon Secours Health System
  • Tacchino
      • Ankara, Tacchino
        • Hacettepe Universitesi Tip Fakultesi
      • Ankara, Tacchino
        • Ankara Universitesi Tip Fakultesi
      • Gaziantep, Tacchino
        • Gaziantep Üniversitesi Tip Fakültesi, Sahinbey Arastirma ve Uygulama Hastanesi
      • Istanbul, Tacchino
        • Istanbul Universitesi Istanbul Tip Fakultesi
      • Mersin, Tacchino
        • Mersin Üniversitesi Tip Fakültesi, Saglik Arastirma ve Uygulama Hastanesi
  • 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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: TDF+Peg-IFN 48 Weeks
TDF plus Peg-IFN for 48 weeks
Droga: TDF
TDF 300 mg tablets administered orally once daily
Altri nomi:
  • Viread®
Droga: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Altri nomi:
  • Pegasys®
Sperimentale: TDF 48 Weeks + Peg-IFN 16 Weeks
TDF plus Peg-IFN for 16 weeks, followed by TDF alone for an additional 32 weeks
Droga: TDF
TDF 300 mg tablets administered orally once daily
Altri nomi:
  • Viread®
Droga: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Altri nomi:
  • Pegasys®
Comparatore attivo: TDF 120 Weeks
TDF monotherapy for 120 weeks
Droga: TDF
TDF 300 mg tablets administered orally once daily
Altri nomi:
  • Viread®
Comparatore attivo: Peg-IFN 48 Weeks
Peg-IFN monotherapy for 48 weeks
Droga: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Altri nomi:
  • Pegasys®

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Gilead Sciences

Investigatori

  • Direttore dello studio: Belinda Jump, Gilead Sciences

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2011

Completamento primario (Effettivo)

1 agosto 2014

Completamento dello studio (Effettivo)

1 luglio 2015

Date di iscrizione allo studio

Primo inviato

13 gennaio 2011

Primo inviato che soddisfa i criteri di controllo qualità

14 gennaio 2011

Primo Inserito (Stima)

17 gennaio 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

26 agosto 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 luglio 2016

Ultimo verificato

1 luglio 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Sponsor e collaboratori

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Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

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