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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 de julho de 2016 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

751

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 75 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: TDF+Peg-IFN 48 Weeks
TDF plus Peg-IFN for 48 weeks
Medicamento: TDF
TDF 300 mg tablets administered orally once daily
Outros nomes:
  • Viread®
Medicamento: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Outros nomes:
  • 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
Medicamento: TDF
TDF 300 mg tablets administered orally once daily
Outros nomes:
  • Viread®
Medicamento: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Outros nomes:
  • Pegasys®
Comparador Ativo: TDF 120 Weeks
TDF monotherapy for 120 weeks
Medicamento: TDF
TDF 300 mg tablets administered orally once daily
Outros nomes:
  • Viread®
Comparador Ativo: Peg-IFN 48 Weeks
Peg-IFN monotherapy for 48 weeks
Medicamento: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Outros nomes:
  • Pegasys®

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Gilead Sciences

Investigadores

  • Diretor de estudo: Belinda Jump, Gilead Sciences

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de abril de 2011

Conclusão Primária (Real)

1 de agosto de 2014

Conclusão do estudo (Real)

1 de julho de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

13 de janeiro de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

14 de janeiro de 2011

Primeira postagem (Estimativa)

17 de janeiro de 2011

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

26 de agosto de 2016

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de julho de 2016

Última verificação

1 de julho de 2016

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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