이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2016년 7월 15일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

751

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: TDF+Peg-IFN 48 Weeks
TDF plus Peg-IFN for 48 weeks
의약품: TDF
TDF 300 mg tablets administered orally once daily
다른 이름들:
  • 비리어드®
의약품: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
다른 이름들:
  • 페가시스®
실험적: TDF 48 Weeks + Peg-IFN 16 Weeks
TDF plus Peg-IFN for 16 weeks, followed by TDF alone for an additional 32 weeks
의약품: TDF
TDF 300 mg tablets administered orally once daily
다른 이름들:
  • 비리어드®
의약품: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
다른 이름들:
  • 페가시스®
활성 비교기: TDF 120 Weeks
TDF monotherapy for 120 weeks
의약품: TDF
TDF 300 mg tablets administered orally once daily
다른 이름들:
  • 비리어드®
활성 비교기: Peg-IFN 48 Weeks
Peg-IFN monotherapy for 48 weeks
의약품: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
다른 이름들:
  • 페가시스®

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Gilead Sciences

수사관

  • 연구 책임자: Belinda Jump, Gilead Sciences

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2011년 4월 1일

기본 완료 (실제)

2014년 8월 1일

연구 완료 (실제)

2015년 7월 1일

연구 등록 날짜

최초 제출

2011년 1월 13일

QC 기준을 충족하는 최초 제출

2011년 1월 14일

처음 게시됨 (추정)

2011년 1월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 8월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 7월 15일

마지막으로 확인됨

2016년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

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

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

만성 B형 간염에 대한 임상 시험

TDF에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Mexico

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다