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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

2016年7月15日更新者：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.

研究概览

地位

完全的

条件

慢性乙型肝炎

干预/治疗

研究类型

介入性

注册 (实际的)

751

阶段

第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：TDF+Peg-IFN 48 Weeks TDF plus Peg-IFN for 48 weeks	药品：TDF TDF 300 mg tablets administered orally once daily 其他名称：威瑞德® 药品：Peg-IFN Peg-IFN 180 µg administered via subcutaneous injection once weekly 其他名称：派罗欣®
实验性的：TDF 48 Weeks + Peg-IFN 16 Weeks TDF plus Peg-IFN for 16 weeks, followed by TDF alone for an additional 32 weeks	药品：TDF TDF 300 mg tablets administered orally once daily 其他名称：威瑞德® 药品：Peg-IFN Peg-IFN 180 µg administered via subcutaneous injection once weekly 其他名称：派罗欣®
有源比较器：TDF 120 Weeks TDF monotherapy for 120 weeks	药品：TDF TDF 300 mg tablets administered orally once daily 其他名称：威瑞德®
有源比较器：Peg-IFN 48 Weeks Peg-IFN monotherapy for 48 weeks	药品：Peg-IFN Peg-IFN 180 µg administered via subcutaneous injection once weekly 其他名称：派罗欣®

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
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 大体时间：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

次要结果测量

结果测量	措施说明	大体时间
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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Gilead Sciences

调查人员

研究主任：Belinda Jump、Gilead Sciences

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年4月1日

初级完成 (实际的)

2014年8月1日

研究完成 (实际的)

2015年7月1日

研究注册日期

首次提交

2011年1月13日

首先提交符合 QC 标准的

2011年1月14日

首次发布 (估计)

2011年1月17日

研究记录更新

最后更新发布 (估计)

2016年8月26日

上次提交的符合 QC 标准的更新

2016年7月15日

最后验证

2016年7月1日

慢性乙型肝炎的临床试验

Lapo Alinari

招聘中

Tegavivint 用于治疗复发或难治性大 B 细胞淋巴瘤患者

伴有 MYC、BCL2 和 BCL6 重排的复发性高级别 B 细胞淋巴瘤 | 具有 MYC、BCL2 和 BCL6 重排的难治性高级 B 细胞淋巴瘤 | 伴有 MYC 和 BCL2 或 BCL6 重排的复发性高级别 B 细胞淋巴瘤 | 具有 MYC 和 BCL2 或 BCL6 重排的难治性高级 B 细胞淋巴瘤 | 复发性弥漫性大 B 细胞淋巴瘤活化 B 细胞型 | 难治性弥漫性大 B 细胞淋巴瘤活化 B 细胞型 | 将惰性 B 细胞非霍奇金淋巴瘤转化为弥漫性大 B 细胞淋巴瘤 | 复发性弥漫性大 B 细胞淋巴瘤生发中心 B 细胞型 | 难治性弥漫性大 B 细胞淋巴瘤生发中心 B 细胞型

美国
Northwestern University
National Cancer Institute (NCI)

主动，不招人

联合化疗和 TAK-659 作为治疗高危弥漫性大 B 细胞淋巴瘤患者的一线治疗

弥漫性大 B 细胞淋巴瘤 | 弥漫性大 B 细胞淋巴瘤，未另行说明 | 高级 B 细胞淋巴瘤，未另行说明 | 富含 T 细胞/组织细胞的大 B 细胞淋巴瘤 | 具有 MYC 和 BCL2 和/或 BCL6 重排的高级别 B 细胞淋巴瘤 | 弥漫性大 B 细胞淋巴瘤活化 B 细胞型 | 弥漫性大 B 细胞淋巴瘤生发中心 B 细胞型

美国
Ohio State University Comprehensive Cancer Center

招聘中

纳米芯片技术在弥漫性大 B 细胞淋巴瘤参与者中监测治疗反应和检测复发

弥漫性大 B 细胞淋巴瘤 | 高级别 B 细胞淋巴瘤 | 弥漫性大 B 细胞淋巴瘤，未另行说明 | 弥漫性大 B 细胞淋巴瘤生发中心 B 细胞型

美国
Roswell Park Cancer Institute
National Cancer Institute (NCI); Amgen

主动，不招人

卡非佐米、利妥昔单抗、异环磷酰胺、卡铂和依托泊苷治疗复发或难治性 I-IV 期弥漫性大 B 细胞淋巴瘤患者

复发性弥漫性大 B 细胞淋巴瘤 | 难治性弥漫性大 B 细胞淋巴瘤 | CD20阳性 | I 期弥漫性大 B 细胞淋巴瘤 | II 期弥漫性大 B 细胞淋巴瘤 | III 期弥漫性大 B 细胞淋巴瘤 | IV 期弥漫性大 B 细胞淋巴瘤

美国
Curocell Inc.

招聘中

CRC01在成人大B细胞淋巴瘤患者中的疗效和安全性研究

高级别 B 细胞淋巴瘤 | 弥漫性大 B 细胞淋巴瘤 (DLBCL) | 原发性纵隔大 B 细胞淋巴瘤 (PMBCL) | 转化的滤泡性淋巴瘤 (TFL) | 难治性大 B 细胞淋巴瘤 | 复发性大 B 细胞淋巴瘤

大韩民国
National Cancer Institute (NCI)

招聘中

测试抗癌药物 Mosunetuzumab、Polatuzumab Vedotin 和来那度胺的组合治疗复发/难治性弥漫性大 B 细胞淋巴瘤

高级别 B 细胞淋巴瘤 | 弥漫性大 B 细胞淋巴瘤，未另行说明 | 将惰性 B 细胞非霍奇金淋巴瘤转化为弥漫性大 B 细胞淋巴瘤

美国
Nathan Denlinger
Bristol-Myers Squibb

招聘中

CC-99282 + 利妥昔单抗早期 CART 治疗非霍奇金淋巴瘤

B 细胞非霍奇金淋巴瘤复发 | 弥漫性大 B 细胞淋巴瘤复发 | 滤泡性淋巴瘤-复发性 | 高级别 B 细胞淋巴瘤-复发 | 原发性纵隔大 B 细胞淋巴瘤复发 | 惰性 B 细胞非霍奇金淋巴瘤转化为弥漫性大 B 细胞淋巴瘤复发 | 难治性 B 细胞非霍奇金淋巴瘤 | 难治性弥漫性大 B 细胞淋巴瘤 | 滤泡性淋巴瘤难治性 | 高级别 B 细胞淋巴瘤难治性 | 原发性纵隔大 B 细胞淋巴瘤难治性 | 将惰性 B 细胞非霍奇金淋巴瘤转化为难治性弥漫性大 B 细胞淋巴瘤

美国
National Cancer Institute (NCI)

主动，不招人

伊布替尼治疗复发或难治性弥漫性大 B 细胞淋巴瘤患者干细胞移植前后

复发性弥漫性大 B 细胞淋巴瘤活化 B 细胞型 | 难治性弥漫性大 B 细胞淋巴瘤活化 B 细胞型

美国, 沙特阿拉伯
Northwestern University
National Cancer Institute (NCI)

招聘中

Zanubrutinib 和 CAR T 细胞疗法用于治疗复发性或难治性侵袭性 B 细胞非霍奇金淋巴瘤或转化惰性 B 细胞淋巴瘤

复发性原发性纵隔（胸腺）大 B 细胞淋巴瘤 | 难治性原发性纵隔（胸腺）大 B 细胞淋巴瘤 | 伴有 MYC、BCL2 和 BCL6 重排的复发性高级别 B 细胞淋巴瘤 | 具有 MYC、BCL2 和 BCL6 重排的难治性高级 B 细胞淋巴瘤 | 复发性弥漫性大 B 细胞淋巴瘤，未另行说明 | 难治性弥漫性大 B 细胞淋巴瘤，未另行说明 | 复发性侵袭性 B 细胞非霍奇金淋巴瘤 | 难治性侵袭性 B 细胞非霍奇金淋巴瘤 | 复发性转化 B 细胞非霍奇金淋巴瘤 | 难治性转化 B 细胞非霍奇金淋巴瘤 | EBV 阳性弥漫性大 B 细胞淋巴瘤，未另行说明 | 高级 B 细胞淋巴瘤，未另行说明 | 与慢性炎症相关的弥漫性大 B 细胞淋巴瘤 | 伴 IRF4... 及其他条件

美国
Patrick C. Johnson, MD
AstraZeneca

招聘中

Acalabrutinib + Liso-Cel 治疗 R/R 侵袭性 B 细胞淋巴瘤

难治性 B 细胞非霍奇金淋巴瘤 | 弥漫性大 B 细胞淋巴瘤 (DLBCL) | 3b 级滤泡性淋巴瘤 | 难治性侵袭性 B 细胞淋巴瘤 | 侵袭性 B 细胞 NHL | 从头或转化的惰性 B 细胞淋巴瘤 | DLBCL，Nos 遗传亚型 | 富含 T 细胞/组织细胞的大 B 细胞淋巴瘤 | EBV 阳性 DLBCL，编号 | 原发性纵隔 [胸腺] 大 B 细胞淋巴瘤 (PMBCL) | 高级 B 细胞淋巴瘤，编号 | C-MYC/BCL6 双重打击高级别 B 细胞淋巴瘤 | C-MYC/BCL2 双重打击高级别 B 细胞淋巴瘤

美国

TDF的临床试验

Gilead Sciences

完全的

替诺福韦 DF + 依法韦仑 (TDF+EFV) 与替诺福韦 DF + 依法韦仑 + 拉米夫定 (TDF+EFV+3TC) 维持方案在病毒学控制的患者中的对比：COOL 试验 (COOL)

艾滋病毒感染

法国
Auritec Pharmaceuticals
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); The... 和其他合作者

完全的

在健康女性中使用抗逆转录病毒阴道环进行 HIV 预防的安全性和药代动力学研究

人类免疫缺陷病毒 (HIV) 预防

美国
Gilead Sciences

完全的

HBeAg 阴性 CHB 长期病毒学抑制后停止 TDF 治疗 (FINITE CHB)

慢性乙型肝炎

德国
Peking Union Medical College

未知

基于拉替拉韦的抗逆转录病毒疗法治疗耐药 HIV-1 感染

爱滋病/HIV问题

中国
Tasly Tianjin Biopharmaceutical Co., Ltd.

未知

治疗性乙型肝炎腺病毒注射液（T101）联合核苷（酸）类似物治疗慢性乙型肝炎患者的安全性和有效性

乙型肝炎病毒 (HBV)

中国
University of Washington
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Columbia... 和其他合作者

完全的

坎帕拉女性骨骼研究

低雌激素 | 骨脱矿 | 亚临床肾损伤 | 骨微结构

乌干达
The HIV Netherlands Australia Thailand Research...
National Health Security Office, Thailand; Swiss HIV Cohort Study

完全的

非核苷类逆转录酶抑制剂 (NNRTI) 治疗失败患者的二线抗逆转录病毒治疗

艾滋病毒感染

泰国
Jiangsu Hansoh Pharmaceutical Co., Ltd.

主动，不招人

HS-10234治疗慢性乙型肝炎病毒感染患者的疗效和安全性研究

慢性乙肝病毒感染

中国
French National Agency for Research on AIDS and...
Merck Sharp & Dohme LLC

完全的

在病毒载量检测不到的 HIV 患者中，抗逆转录病毒治疗方案中从恩夫韦汀转换为拉替拉韦的疗效和耐受性 (EASIER)

艾滋病毒感染

法国
Huashan Hospital
The First Affiliated Hospital with Nanjing Medical University; Peking University First Hospital 和其他合作者

招聘中

优化核苷酸类似物的真实世界研究

乙型肝炎，慢性

中国

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

研究概览

地位

条件

干预/治疗

研究类型

注册 (实际的)

阶段

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

有资格学习的性别

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

调查人员

出版物和有用的链接

一般刊物

研究记录日期

研究主要日期

学习开始

初级完成 (实际的)

研究完成 (实际的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (估计)

研究记录更新

最后更新发布 (估计)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

慢性乙型肝炎的临床试验

TDF的临床试验

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医疗条件

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条件

罕见疾病

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膳食补充剂

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