Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (Peg-IFN) Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis B
Official Title
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)
Acronym
Not provided
Organization
Gilead SciencesINDUSTRY
Status Module
Record Verification Date
Jul 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2011
Primary Completion Date
Aug 2014Actual
Completion Date
Jul 2015Actual
First Submitted Date
Jan 13, 2011
First Submission Date that Met QC Criteria
Jan 14, 2011
First Posted Date
Jan 17, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 10, 2015
Results First Submitted that Met QC Criteria
Aug 10, 2015
Results First Posted Date
Sep 9, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 15, 2016
Last Update Posted Date
Aug 26, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Gilead SciencesINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
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.
Detailed Description
Not provided
Conditions Module
Conditions
Chronic Hepatitis B
Keywords
Chronic Hepatitis B
Hep B
Non cirrhotic
Tenofovir disoproxil fumarate (TDF)
Peginterferon α-2a (Peg-IFN)
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 4
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
751Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
TDF+Peg-IFN 48 Weeks
Experimental
TDF plus Peg-IFN for 48 weeks
Drug: TDF
Drug: Peg-IFN
TDF 48 Weeks + Peg-IFN 16 Weeks
Experimental
TDF plus Peg-IFN for 16 weeks, followed by TDF alone for an additional 32 weeks
Drug: TDF
Drug: Peg-IFN
TDF 120 Weeks
Active Comparator
TDF monotherapy for 120 weeks
Drug: TDF
Peg-IFN 48 Weeks
Active Comparator
Peg-IFN monotherapy for 48 weeks
Drug: Peg-IFN
Interventions
Name
Type
Description
Arm Group Labels
Other Names
TDF
Drug
TDF 300 mg tablets administered orally once daily
TDF 120 Weeks
TDF 48 Weeks + Peg-IFN 16 Weeks
TDF+Peg-IFN 48 Weeks
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
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
Secondary Outcomes
Measure
Description
Time Frame
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
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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)
Participants were enrolled at study sites in North America, Europe, Asia, and Australia. The first participant was screened on 12 April 2011. The last study visit occurred on 17 July 2015.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
TDF+Peg-IFN 48 Weeks
Tenofovir disoproxil fumarate (TDF) 300 mg tablet once daily plus peginterferon α-2a (Peg-IFN) 180 µg subcutaneous (s.c.) injection once weekly for 48 weeks
FG001
TDF 48 Weeks + Peg-IFN 16 Weeks
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Viread®
Peg-IFN
Drug
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Peg-IFN 48 Weeks
TDF 48 Weeks + Peg-IFN 16 Weeks
TDF+Peg-IFN 48 Weeks
Pegasys®
Baseline; Week 72
Percentage of Participants With HBsAg Loss at 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
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
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
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
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
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
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
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
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
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
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
Participants in the TDF 120 week group were not eligible to enter the retreatment phase and are not presented.
Up to 120 weeks
Palo Alto
California
United States
Research and Education Inc
San Diego
California
United States
San Jose Gastroenterology
San Jose
California
United States
Avail Clinical Research, LLC
DeLand
Florida
United States
Centre for Advanced Gastroenterology
Maitland
Florida
United States
University of Miami / Jackson Memorial Medical Center
Miami
Florida
United States
University of Chicago
Chicago
Illinois
United States
LSU Gastroenterology/Center for Digestive Diseases
New Orleans
Louisiana
United States
Tulane University Hospital and Clinic
New Orleans
Louisiana
United States
Digestive Disease Associates
Baltimore
Maryland
United States
Tufts Medical Center
Boston
Massachusetts
United States
Henry Ford Hospital
Detroit
Michigan
United States
ID Care, Inc.
Hillsborough
New Jersey
United States
Medical Procare, PLLC
Flushing
New York
United States
North Shore University Hospital
Great Neck
New York
United States
Beth Israel Medical Center
New York
New York
United States
New York Univ. Medical Center
New York
New York
United States
Weill Cornell Medical College of Cornell University
New York
New York
United States
Private Practice
Philadelphia
Pennsylvania
United States
Advanced Liver Therapies at St. Luke's Episcopal Hospital
Houston
Texas
United States
Kelsey Research Foundation
Houston
Texas
United States
Liver Associates of Texas,
Houston
Texas
United States
University of Utah
Salt Lake City
Utah
United States
Liver Institute of Virginia, Bon Secours Health System
Richmond
Virginia
United States
McGuire Research Institute
Richmond
Virginia
United States
Royal Prince Alfred Hospital
Camperdown
New South Wales
Australia
Concord Repatriation General Hospital
Concord
New South Wales
Australia
Saint George's Hospital
Kogarah
New South Wales
Australia
Liverpool Hospital,Gastroenterology Department
Liverpool
New South Wales
Australia
Westmead Hospital
Westmead
New South Wales
Australia
Royal Brisbane & Women's Hospital
Herston
Queensland
Australia
Princess Alexandra Hospital
Woolloongabba
Queensland
Australia
Flinders Medical Center
Adelaide
South Australia
Australia
Royal Adelaide Hospital
Adelaide SA
South Australia
Australia
Monash Medical Centre
Clayton
Victoria
Australia
Saint Vincents Hospital
Fitzroy
Victoria
Australia
Western Hospital
Footscray
Victoria
Australia
Austin Health
Heidelberg
Victoria
Australia
Alfred Hospital
Melbourne
Victoria
Australia
Box Hill Hospital
Melbourne
Victoria
Australia
Royal Melbourne Hospital
Parkville
Victoria
Australia
Fremantle Hospital
Fremantle
Australia
Sir Charles Gairdner Hospital
Nedlands
Australia
Royal Perth Hospital
Perth
Australia
Heritage Med Research Clinic, Univ of Calgary
Calgary
Alberta
Canada
University of Alberta, Zeidler Ledcore Centre
Zeidler Ledcore Centre
Alberta
Canada
Gastrointestional Research Institute
Vancouver
British Columbia
Canada
Gordon & Leslie Diamond Health Care Centre
Vancouver
British Columbia
Canada
Liver and Intestinal Research Centre
Vancouver
British Columbia
Canada
The Ottawa Hospital,Division of Infectious Diseases
Ottawa
Ontario
Canada
Toronto General Hospital
Toronto
Ontario
Canada
Toronto Liver Centre
Toronto
Ontario
Canada
Hôpital Beaujon, Service Hepatologie- Centre Pierre Abrami
Clichy
Cedex
France
Hôpital de la Croix Rousse
Lyon
Cedex
France
Hopital Tenon
Paris
France
Centre Hospitalier Universitaire de Rennes
Rennes
France
Hopital Charles Nicolle
Rouen
France
Centre Hospitalier Regional et Universitaire de Strasbourg, Hopital Civil
Strasbourg
France
Centre Hospitalier Universitaire Purpan
Toulouse
France
Hopital Paul Brousse
Villejuif
France
Johannes Gutenberg-Universitat Mainz,
Mainz
Rhineland-Palatinate
Germany
Charite Berlin
Berlin
Germany
Universitatsklinik Koln
Cologne
Germany
Universitätsklinikum Essen - klinikum für Gastroenterolgie und Hepatologie,
Essen
Germany
Johann-Wolfgang-Goethe Universitat,
Frankfurt
Germany
Asklepios Westklinikum
Hamburg
Germany
Medizinische Hochschule Hannover,Hastroenterologie und Hepatologie
Hanover
Germany
Universitatsklinikum Leipzig
Leipzig
Germany
Ippokratio Hospital Salonica
Thessaloniki
Attica
Greece
Ippokratio Hospital Athens
Attica
Greece
General University Hospital of Patras
Pátrai
Greece
Hippokration General Hospital of Thessaloniki
Thessaloniki
Greece
Queen Mary Hospital
Hong Kong
Hong Kong
Princess Margaret Hospital
Kowloon
Hong Kong
Prince of Wales Hospital
Shatin
Hong Kong
Alice Ho Miu Ling Nethersole Hospital
Tai Po
Hong Kong
Global Hospital, Lakdi Ka Pul
Hyderabad
Andhra Pradesh
India
Institute of digestive and liver disease, Dispur Hospital Ganeshguri
Guwahati
Assam
India
Vedanta Institute of Medical Sciences
Ahmedabad
Gujarat
India
Liver Clinic
Surat
Gujarat
India
Manipal Hospitals
Bangalore
Karnataka
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
Mumbai
Maharashtra
India
Midas Institute of Gastroenterology
Nagpur
Maharashtra
India
Dharamasi Hospital,Chandni Chowk, South Shivajinagar,
Sangli
Maharashtra
India
All India Institute of Medical Sciences, Ansari Nagar
Delhi
New Delhi
India
Institute of Liver and Biliary Sciences
New Delhi
New Delhi
India
VGM Hospital
Coimbatore
Tamil Nadu
India
Institute of Post Graduate Medical Education And Research
Kolkata
West Bengal
India
Azienda Ospedaliero-Universitaria di Cagliari
Monserrato
Cagliari
Italy
Fondazione IRCCS Ca Granda - Ospedale Maggiore Policlinico
Milan
Italy
Ospedale San Raffaele
Milan
Italy
Seconda Universita degli Studi di Napoli
Naples
Italy
Azienda Ospedaliera di Parma,Department of Infectious Diseases and hepatology
Parma
Italy
Fondazione PTV - Policlinico Tor Vergata
Roma
Italy
Policlinico Umberto I
Rome
Italy
University of Milan,Azienda Ospedaliera San Giovanni, Battista di Torino,Dipartimento di Gastroenterologia
Yonsei Unversity Wonju College of Medicine Wonju Christian Hospital
Wŏnju
Gangwon-do
South Korea
Korea University Ansan Hospital
Ansan-si
Gyeonggi-d
South Korea
Bucheon St. Mary's Hospital
Bucheon-si
Gyeonggi-d
South Korea
Korea University Guro Hospital
Seoul
Gyeonggi-d
South Korea
CHA Bundang Medical Center, CHA University
Sungnam
Gyeonggi-d
South Korea
Pusan National University Hospital
Busan
Gyeongsang
South Korea
Kyungpook National University Hospital
Daegu
Gyeongsang
South Korea
Pusan National University Yangsan Hospital
Yangsan
Gyeongsang
South Korea
Inje University Busan Paik Hospital
Busan
South Korea
Inje University Ilsan Paik Hospital
Goyang, Gyeonggi-Do
South Korea
Digestive Disease Cntr, Konkuk Univ Hosp
Kwangjin-gu, Seoul
South Korea
Asan Medical Center
Seoul
South Korea
Gangnam Severance Hospital
Seoul
South Korea
Konkuk University Medical Center
Seoul
South Korea
Samsung Medical Center
Seoul
South Korea
Seoul National University Hospital
Seoul
South Korea
Seoul Saint Mary's Hospital
Seoul
South Korea
Hospital Universitario de La Princesa
Madrid
Madrid
Spain
Hospital General Universitari Vall d' Hebron
Barcelona
Spain
Hospital Carlos III
Madrid
Spain
Hospital Virgen de la Victoria
Málaga
Spain
Hospital Universitario Virgen del Rocio
Seville
Spain
Hospital Meixoeiro
Vigo, Pontevedra
Spain
Far-Eastern Memorial Hosp
New Taipei City
Banciao Dist
Taiwan
Chang Gung Medical Foundation.LinKou Branch
Taoyuan
Taoyuan
Taiwan
Changhua Christain Hospital
Changhua
Taiwan
Chiayi Christian Hosp
Chiayi City
Taiwan
Buddhist Tzu Chi General Hospital
Hualien City
Taiwan
Chang Gung Memorial Hospital
Kaohsiung City
Taiwan
Kaohsiung Medical University Hospital
Kaosiung
Taiwan
Chang Gung Medical Foundation-Keelung
Keelung Town/KEELUNG CITY
Taiwan
China Medical University Hospital
Taichung
Taiwan
Chung Shan Medical University Hospital
Taichung
Taiwan
Taichung Veterans Genl Hosp
Taichung
Taiwan
National Cheng Kung University Hospital
Tainan
Taiwan
Cathay General Hospital
Taipei
Taiwan
National Taiwan University Hospital
Taipei
Taiwan
Ankara Üniversitesi Tip Fakültesi
Ankara
Ankara
Turkey (Türkiye)
Hacettepe Üniversitesi Tip Fakültesi
Ankara
Ankara
Turkey (Türkiye)
Gaziantep Üniversitesi Tip Fakültesi, Sahinbey Arastirma ve Uygulama Hastanesi
Gaziantep
Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul
Turkey (Türkiye)
Mersin Üniversitesi Tip Fakültesi, Saglik Arastirma ve Uygulama Hastanesi
Mersin
Turkey (Türkiye)
The Queen Elizabeth Hospital
Birmingham, Wstmid
United Kingdom
Royal Free Hospital
Hampstead,London
United Kingdom
Barts and The London NHS Trust
London
United Kingdom
King's College Hospital
London
United Kingdom
Result
Chan HL, Elkhashab M, Trinh H, Tak WY, Ma X, Chuang WL, Kim YJ, Martins EB, Lin L, Dinh P, Charuworn P, Foster GR, Marcellin P. Association of baseline vitamin D levels with clinical parameters and treatment outcomes in chronic hepatitis B. J Hepatol. 2015 Nov;63(5):1086-92. doi: 10.1016/j.jhep.2015.06.025. Epub 2015 Jul 2.
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
FG002
TDF 120 Weeks
TDF 300 mg tablet once daily for 120 weeks
FG003
Peg-IFN 48 Weeks
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
FG000188 subjects
FG001187 subjects
FG002190 subjects
FG003186 subjects
COMPLETED
FG000151 subjects
FG001139 subjects
FG002163 subjects
FG003150 subjects
NOT COMPLETED
FG00037 subjects
FG00148 subjects
FG00227 subjects
FG00336 subjects
Type
Comment
Reasons
Adverse Event
FG0005 subjects
FG0013 subjects
FG0020 subjects
FG0037 subjects
Withdrawal by Subject
FG00018 subjects
FG00121 subjects
FG0028 subjects
FG00317 subjects
Lost to Follow-up
FG0007 subjects
FG0019 subjects
FG0024 subjects
FG0032 subjects
Physician Decision
FG0003 subjects
FG0015 subjects
FG0021 subjects
FG0036 subjects
Pregnancy
FG0002 subjects
FG0012 subjects
FG0024 subjects
FG0031 subjects
Noncompliance with Study Drug
FG0001 subjects
FG0013 subjects
FG0022 subjects
FG0030 subjects
Subject Never Dosed with Study Drug
FG0001 subjects
FG0012 subjects
FG0023 subjects
FG0031 subjects
Protocol Violation
FG0000 subjects
FG0012 subjects
FG0025 subjects
FG0030 subjects
Subject Terminated from Study by Sponsor
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
11 participants were never dosed are not included in the Safety Analysis Set due to the following reasons for discontinuation: 7 = Subject Never Dosed with Study Drug; 4 = Withdrawal by Subject.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
TDF+Peg-IFN 48 Weeks
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
BG001
TDF 48 Weeks + Peg-IFN 16 Week
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
BG002
TDF 120 Weeks
TDF 300 mg tablet once daily for 120 weeks
BG003
Peg-IFN 48 Weeks
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000186
BG001184
BG002185
BG003185
BG004740
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00038± 10.7
BG00137± 9.9
BG00236± 10.8
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00059
BG00165
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0004
BG0014
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
Asian
Title
Measurements
BG000142
BG001134
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Romania
Title
Measurements
BG00012
BG00115
BG002
Hepatitis B Surface Antigen (HBsAg)
Mean
Standard Deviation
log 10 IU/mL
Title
Denominators
Categories
Title
Measurements
BG0003.88± 0.840
BG0013.84± 0.849
BG002
Hepatitis B e Antigen (HBeAg) Status
Number
participants
Title
Denominators
Categories
Reactive
Title
Measurements
BG000108
BG001105
BG002
Hepatitis B Virus (HBV) DNA
Mean
Standard Deviation
log 10 IU/mL
Title
Denominators
Categories
Title
Measurements
BG0007.06± 1.542
BG0017.13± 1.505
BG002
HBV Genotype
Number
participants
Title
Denominators
Categories
Genotype A
Title
Measurements
BG00017
BG00116
BG002
Alanine Aminotransferase (ALT)
Mean
Standard Deviation
U/L
Title
Denominators
Categories
Title
Measurements
BG000121.2± 180.82
BG001112.2± 94.44
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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
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.
Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants in the TDF+Peg-IFN 48 Weeks, TDF 120 Weeks, and Peg-IFN 48 Weeks groups were analyzed by randomized treatment.
Posted
Number
percentage of participants
Baseline; Week 72
ID
Title
Description
OG000
TDF+Peg-IFN 48 Weeks
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
OG001
TDF 120 Weeks
TDF 300 mg tablet once daily for 120 weeks
OG002
Peg-IFN 48 Weeks
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
Units
Counts
Participants
OG000186
OG001185
OG002185
Title
Denominators
Categories
Title
Measurements
OG0009.05
OG0010.00
OG0022.84
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
< 0.001
Raw p-values comparing treatments were based on a log-rank test stratified by HBeAg status and viral genotype.
2-Sided
No
Superiority or Other
OG000
OG002
Log Rank
Secondary
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
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.
Full Analysis Set. Participants in the TDF 48 week + Peg-IFN 16 Weeks, TDF 120 Weeks, and Peg-IFN 48 Weeks groups were analyzed.
Posted
Number
percentage of participants
Baseline; Week 72
ID
Title
Description
OG000
TDF 48 Weeks + Peg-IFN 16 Weeks
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
OG001
TDF 120 Weeks
TDF 300 mg tablet once daily for 120 weeks
OG002
Peg-IFN 48 Weeks
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
Secondary
Percentage of Participants With HBsAg Loss at 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.
Full Analysis Set
Posted
Number
percentage of participants
Baseline; Weeks 96 and 120
ID
Title
Description
OG000
TDF+Peg-IFN 48 Weeks
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
OG001
TDF 48 Weeks + Peg-IFN 16 Weeks
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
OG002
TDF 120 Week
TDF 300 mg tablet once daily for 120 weeks
OG003
Peg-IFN 48 Weeks
Secondary
Percentage of Participants With HBsAg Seroconversion at 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.
Full Analysis Set
Posted
Number
percentage of participants
Baseline; Weeks 72, 96, and 120
ID
Title
Description
OG000
TDF+Peg-IFN 48 Weeks
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
OG001
TDF 48 Weeks + Peg-IFN 16 Weeks
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
OG002
TDF 120 Weeks
TDF 300 mg tablet once daily for 120 weeks
OG003
Secondary
Percentage of Participants With HBeAg Loss and Seroconversion at 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.
Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome.
Posted
Number
percentage of participants
Baseline; Week 72
ID
Title
Description
OG000
TDF+Peg-IFN 48 Week (Not Retreated)
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
OG001
TDF+Peg-IFN 48 Weeks (Retreated)
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Secondary
Percentage of Participants With HBeAg Loss and Seroconversion at 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.
Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome.
Posted
Number
percentage of participants
Baseline; Week 96
ID
Title
Description
OG000
TDF+Peg-IFN 48 Week (Not Retreated)
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
OG001
TDF+Peg-IFN 48 Weeks (Retreated)
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Secondary
Percentage of Participants With HBeAg Loss and Seroconversion at 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.
Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome.
Posted
Number
percentage of participants
Baseline; Week 120
ID
Title
Description
OG000
TDF+Peg-IFN 48 Week (Not Retreated)
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
OG001
TDF+Peg-IFN 48 Weeks (Retreated)
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Secondary
Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at 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.
Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.
Posted
Number
percentage of participants
Week 72
ID
Title
Description
OG000
TDF+Peg-IFN 48 Weeks (Not Retreated)
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
OG001
TDF+Peg-IFN 48 Weeks (Retreated)
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
OG002
TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
Secondary
Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at 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.
Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.
Posted
Number
percentage of participants
Week 96
ID
Title
Description
OG000
TDF+Peg-IFN 48 Weeks (Not Retreated)
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
OG001
TDF+Peg-IFN 48 Weeks (Retreated)
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
OG002
TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
Secondary
Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at 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.
Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.
Posted
Number
percentage of participants
Week 120
ID
Title
Description
OG000
TDF+Peg-IFN 48 Weeks (Not Retreated)
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
OG001
TDF+Peg-IFN 48 Weeks (Retreated)
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
OG002
TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
Secondary
Percentage of Participants With Normal ALT at 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.
Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.
Posted
Number
percentage of participants
Week 72
ID
Title
Description
OG000
TDF+Peg-IFN 48 Weeks (Not Retreated)
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
OG001
TDF+Peg-IFN 48 Weeks (Retreated)
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
OG002
TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)
Secondary
Percentage of Participants With Normal ALT at 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.
Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.
Posted
Number
percentage of participants
Week 96
ID
Title
Description
OG000
TDF+Peg-IFN 48 Weeks (Not Retreated)
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
OG001
TDF+Peg-IFN 48 Weeks (Retreated)
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
OG002
TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)
Secondary
Percentage of Participants With Normal ALT at 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.
Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.
Posted
Number
percentage of participants
Week 120
ID
Title
Description
OG000
TDF+Peg-IFN 48 Weeks (Not Retreated)
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
OG001
TDF+Peg-IFN 48 Weeks (Retreated)
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
OG002
TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)
Secondary
Percentage of Participants Who Required Retreatment
Participants in the TDF 120 week group were not eligible to enter the retreatment phase and are not presented.
Safety Analysis Set. Participants in the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups were analyzed.
Posted
Number
percentage of participants
Up to 120 weeks
ID
Title
Description
OG000
TDF+Peg-IFN 48 Weeks
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
OG001
TDF 48 Weeks + Peg-IFN 16 Weeks
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
OG002
Peg-IFN 48 Weeks
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
Units
Counts
Participants
Time Frame
Up to 120 weeks plus 30 days
Description
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
TDF+Peg-IFN 48 Weeks (Not Retreated)
Adverse events in this reporting group are those occurring in participants who were not retreated or before retreatment through last non-retreatment dose plus 30 days.
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
21
186
147
186
EG001
TDF+Peg-IFN 48 Weeks (Retreated)
Adverse events in this reporting group are those occurring after TDF retreatment through last TDF retreatment dose plus 30 days.
TDF 300 mg tablet once daily up to Week 120
7
112
26
112
EG002
TDF 48 Week + Peg-IFN 16 Weeks (Not Retreated)
Adverse events in this reporting group are those occurring in participants who were not retreated or before retreatment through last non-retreatment dose plus 30 days.
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
18
184
142
184
EG003
TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)
Adverse events in this reporting group are those occurring after TDF retreatment through last TDF retreatment dose plus 30 days.
TDF 300 mg tablet once daily up to Week 120
3
115
31
115
EG004
TDF 120 Weeks
Adverse events in this reporting group are those occurring during the initial treatment phase (up to 120 weeks plus 30 days).
TDF 300 mg tablet once daily for up to 120 weeks
13
185
89
185
EG005
Peg-IFN 48 Weeks (Not Retreated)
Adverse events in this reporting group are those occurring in participants who were not retreated or before retreatment through last non-retreatment dose plus 30 days.
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
18
185
152
185
EG006
Peg-IFN 48 Weeks (Retreated)
Adverse events in this reporting group are those occurring during the retreatment phase (from start of retreatment up to Week 120 plus 30 days).
TDF 300 mg tablet once daily up to Week 120
6
117
33
117
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG0030 affected115 at risk
EG0040 affected185 at risk
EG0050 affected185 at risk
EG0060 affected117 at risk
Atrial septal defect acquired
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0021 affected184 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0021 affected184 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected186 at risk
EG0010 affected112 at risk
EG0021 affected184 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0021 affected184 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Cholangitis acute
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Cholecystitis chronic
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected186 at risk
EG0012 affected112 at risk
EG0024 affected184 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Psoas abscess
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Alanine aminotransferase abnormal
Investigations
MedDRA 18.0
Systematic Assessment
EG0001 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0006 affected186 at risk
EG0013 affected112 at risk
EG0028 affected184 at risk
EG003
Amylase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0001 affected186 at risk
EG0012 affected112 at risk
EG0021 affected184 at risk
EG003
Lipase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Transaminases increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0021 affected184 at risk
EG003
Cholesterosis
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0011 affected112 at risk
EG0020 affected184 at risk
EG003
Adenocarcinoma of the cervix
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Benign neoplasm of bladder
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Brain cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0021 affected184 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Cholangiocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0011 affected112 at risk
EG0020 affected184 at risk
EG003
Gallbladder neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0021 affected184 at risk
EG003
Haemangioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Hepatocellular carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0021 affected184 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0021 affected184 at risk
EG003
Mixed hepatocellular cholangiocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0011 affected112 at risk
EG0020 affected184 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Myelopathy
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA 18.0
Systematic Assessment
EG0001 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Depression
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected186 at risk
EG0010 affected112 at risk
EG0020 affected184 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Neutropenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG00015 affected186 at risk
EG0010 affected112 at risk
EG00211 affected184 at risk
EG0031 affected115 at risk
EG0040 affected185 at risk
EG00515 affected185 at risk
EG0060 affected117 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0007 affected186 at risk
EG0011 affected112 at risk
EG0026 affected184 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG00011 affected186 at risk
EG0012 affected112 at risk
EG0027 affected184 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG00013 affected186 at risk
EG0012 affected112 at risk
EG00210 affected184 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0009 affected186 at risk
EG0011 affected112 at risk
EG0026 affected184 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG00026 affected186 at risk
EG0010 affected112 at risk
EG00224 affected184 at risk
EG003
Asthenia
General disorders
MedDRA 18.0
Systematic Assessment
EG00020 affected186 at risk
EG0010 affected112 at risk
EG0029 affected184 at risk
EG003
Chills
General disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected186 at risk
EG0010 affected112 at risk
EG00213 affected184 at risk
EG003
Fatigue
General disorders
MedDRA 18.0
Systematic Assessment
EG00040 affected186 at risk
EG0012 affected112 at risk
EG00233 affected184 at risk
EG003
Influenza like illness
General disorders
MedDRA 18.0
Systematic Assessment
EG00019 affected186 at risk
EG0010 affected112 at risk
EG00217 affected184 at risk
EG003
Injection site erythema
General disorders
MedDRA 18.0
Systematic Assessment
EG00012 affected186 at risk
EG0010 affected112 at risk
EG00211 affected184 at risk
EG003
Malaise
General disorders
MedDRA 18.0
Systematic Assessment
EG00020 affected186 at risk
EG0010 affected112 at risk
EG00212 affected184 at risk
EG003
Pain
General disorders
MedDRA 18.0
Systematic Assessment
EG0008 affected186 at risk
EG0010 affected112 at risk
EG0025 affected184 at risk
EG003
Pyrexia
General disorders
MedDRA 18.0
Systematic Assessment
EG00039 affected186 at risk
EG0011 affected112 at risk
EG00236 affected184 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0005 affected186 at risk
EG0013 affected112 at risk
EG00216 affected184 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00010 affected186 at risk
EG0013 affected112 at risk
EG0029 affected184 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG00023 affected186 at risk
EG0010 affected112 at risk
EG00236 affected184 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0009 affected186 at risk
EG0013 affected112 at risk
EG00211 affected184 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG00016 affected186 at risk
EG0013 affected112 at risk
EG00211 affected184 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected186 at risk
EG0012 affected112 at risk
EG0022 affected184 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG00029 affected186 at risk
EG0010 affected112 at risk
EG00236 affected184 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG00020 affected186 at risk
EG0010 affected112 at risk
EG00218 affected184 at risk
EG003
Headache
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG00054 affected186 at risk
EG0013 affected112 at risk
EG00237 affected184 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG00019 affected186 at risk
EG0013 affected112 at risk
EG00214 affected184 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG00011 affected186 at risk
EG0011 affected112 at risk
EG0022 affected184 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG00011 affected186 at risk
EG0013 affected112 at risk
EG0029 affected184 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG00010 affected186 at risk
EG0013 affected112 at risk
EG0025 affected184 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG00046 affected186 at risk
EG0010 affected112 at risk
EG00232 affected184 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG00014 affected186 at risk
EG0010 affected112 at risk
EG00214 affected184 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG00020 affected186 at risk
EG0011 affected112 at risk
EG00217 affected184 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
The study has been completed at all study sites for at least 2 years
Point of Contact
Title
Organization
Phone
Extension
Email
Clinical Trial Disclosures
Gilead Sciences
ClinicalTrialDisclosures@gilead.com
ID
Term
D019694
Hepatitis B, Chronic
Ancestor Terms
ID
Term
D006509
Hepatitis B
D000086982
Blood-Borne Infections
D003141
Communicable Diseases
D007239
Infections
D018347
Hepadnaviridae Infections
D004266
DNA Virus Infections
D014777
Virus Diseases
D006525
Hepatitis, Viral, Human
D006521
Hepatitis, Chronic
D006505
Hepatitis
D008107
Liver Diseases
D004066
Digestive System Diseases
D002908
Chronic Disease
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000068698
Tenofovir
C100416
peginterferon alfa-2a
Ancestor Terms
ID
Term
D063065
Organophosphonates
D009943
Organophosphorus Compounds
D009930
Organic Chemicals
D000225
Adenine
D011687
Purines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
38
± 10.5
BG00437± 10.5
64
BG00366
BG004254
Male
BG000127
BG001119
BG002121
BG003119
BG004486
3
BG0037
BG00418
Not Hispanic or Latino
BG000182
BG001179
BG002181
BG003177
BG004719
Unknown or Not Reported
BG0000
BG0011
BG0021
BG0031
BG0043
141
BG003137
BG004554
Black or African American
Title
Measurements
BG0005
BG0013
BG0024
BG0036
BG00418
Native Hawaiian or Other Pacific Islander
Title
Measurements
BG0002
BG0010
BG0020
BG0031
BG0043
White
Title
Measurements
BG00036
BG00145
BG00239
BG00341
BG004161
Other
Title
Measurements
BG0001
BG0012
BG0021
BG0030
BG0044
13
BG0039
BG00449
Singapore
Title
Measurements
BG0007
BG0015
BG0027
BG0038
BG00427
Hong Kong
Title
Measurements
BG00025
BG00124
BG00227
BG00321
BG00497
United States
Title
Measurements
BG00019
BG00117
BG00223
BG00326
BG00485
United Kingdom
Title
Measurements
BG0002
BG0013
BG0021
BG0034
BG00410
Portugal
Title
Measurements
BG0000
BG0013
BG0020
BG0030
BG0043
India
Title
Measurements
BG00010
BG0015
BG0029
BG0036
BG00430
Spain
Title
Measurements
BG0003
BG0013
BG0023
BG0035
BG00414
Greece
Title
Measurements
BG0000
BG0013
BG0022
BG0034
BG0049
Canada
Title
Measurements
BG00019
BG00114
BG00214
BG00311
BG00458
Netherlands
Title
Measurements
BG0002
BG0011
BG0020
BG0031
BG0044
Turkey
Title
Measurements
BG0005
BG0016
BG0026
BG0037
BG00424
Taiwan
Title
Measurements
BG00020
BG00115
BG00212
BG00319
BG00466
Korea, Republic of
Title
Measurements
BG00034
BG00138
BG00238
BG00335
BG004145
Poland
Title
Measurements
BG0004
BG0017
BG0026
BG0035
BG00422
Italy
Title
Measurements
BG0002
BG0011
BG0024
BG0034
BG00411
Australia
Title
Measurements
BG00010
BG00114
BG00215
BG00314
BG00453
France
Title
Measurements
BG0006
BG0013
BG0021
BG0033
BG00413
Germany
Title
Measurements
BG0006
BG0017
BG0024
BG0033
BG00420
3.89
± 0.812
BG0033.76± 0.844
BG0043.84± 0.836
109
BG003106
BG004428
Nonreactive
Title
Measurements
BG00078
BG00179
BG00276
BG00379
BG004312
7.02
± 1.550
BG0036.94± 1.619
BG0047.04± 1.553
14
BG00314
BG00461
Genotype B
Title
Measurements
BG00050
BG00151
BG00249
BG00353
BG004203
Genotype C
Title
Measurements
BG00078
BG00179
BG00278
BG00379
BG004314
Genotype D
Title
Measurements
BG00039
BG00136
BG00241
BG00338
BG004154
Genotype E-H
Title
Measurements
BG0002
BG0012
BG0023
BG0031
BG0048
100.9
± 67.65
BG003106.6± 91.51
BG004110.3± 116.94
0.002
Raw p-values comparing treatments were based on a log-rank test stratified by HBeAg status and viral genotype.
2-Sided
No
Superiority or Other
Units
Counts
Participants
OG000184
OG001185
OG002185
Title
Denominators
Categories
Title
Measurements
OG0002.83
OG0010.00
OG0022.84
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
Units
Counts
Participants
OG000186
OG001184
OG002185
OG003185
Title
Denominators
Categories
Week 96
Title
Measurements
OG0009.69
OG0013.49
OG0020.00
OG0032.84
Week 120
Title
Measurements
OG00010.36
OG0013.49
OG0020.00
OG003
Peg-IFN 48 Weeks
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
Units
Counts
Participants
OG000186
OG001184
OG002185
OG003185
Title
Denominators
Categories
Week 72
Title
Measurements
OG0008.05
OG0010.56
OG0020.00
OG0032.87
Week 96
Title
Measurements
OG0008.05
OG0010.56
OG0020.00
OG003
Week 120
Title
Measurements
OG00010.08
OG0010.56
OG0020.00
OG003
OG002
TDF 48 Weeks + Peg-IFN 16 Week (Not Retreated)
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
OG003
TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
OG004
TDF 120 Weeks
TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
OG005
Peg-IFN 48 Weeks (Not Retreated)
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
OG006
Peg-IFN 48 Weeks (Retreated)
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Units
Counts
Participants
OG00076
OG00132
OG00261
OG00344
OG004109
OG00564
OG00642
Title
Denominators
Categories
HBeAg Loss
Title
Measurements
OG00035.5
OG00115.6
OG00232.8
OG00315.9
OG00414.7
OG00532.8
OG00614.3
HBeAg Seroconversion
Title
Measurements
OG00028.9
OG00115.6
OG00231.1
OG003
OG002
TDF 48 Weeks + Peg-IFN 16 Week (Not Retreated)
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
OG003
TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
OG004
TDF 120 Weeks
TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
OG005
Peg-IFN 48 Weeks (Not Retreated)
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
OG006
Peg-IFN 48 Weeks (Retreated)
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Units
Counts
Participants
OG00044
OG00164
OG00244
OG00361
OG004109
OG00537
OG00669
Title
Denominators
Categories
HBeAg Loss
Title
Measurements
OG00043.2
OG00120.3
OG00245.5
OG00314.8
OG00418.3
OG00537.8
OG00614.5
HBeAg Seroconversion
Title
Measurements
OG00036.4
OG00118.8
OG00243.2
OG003
OG002
TDF 48 Weeks + Peg-IFN 16 Week (Not Retreated)
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
OG003
TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
OG004
TDF 120 Weeks
TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
OG005
Peg-IFN 48 Weeks (Not Retreated)
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
OG006
Peg-IFN 48 Weeks (Retreated)
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Units
Counts
Participants
OG00044
OG00164
OG00240
OG00365
OG004109
OG00536
OG00670
Title
Denominators
Categories
HBeAg Loss
Title
Measurements
OG00038.6
OG00125.0
OG00237.5
OG00323.1
OG00420.2
OG00533.3
OG00618.6
HBeAg Seroconversion
Title
Measurements
OG00029.5
OG00121.9
OG00235.0
OG003
OG003
TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
OG004
TDF 120 Weeks
TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
OG005
Peg-IFN 48 Weeks (Not Retreated)
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
OG006
Peg-IFN 48 Weeks (Retreated)
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Units
Counts
Participants
OG000144
OG00142
OG002131
OG00353
OG004185
OG005128
OG00657
Title
Denominators
Categories
Title
Measurements
OG00015.3
OG00126.2
OG00214.5
OG00315.1
OG00484.9
OG00511.7
OG00640.4
OG003
TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
OG004
TDF 120 Weeks
TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
OG005
Peg-IFN 48 Weeks (Not Retreated)
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
OG006
Peg-IFN 48 Weeks (Retreated)
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Units
Counts
Participants
OG00083
OG001103
OG00283
OG003101
OG004185
OG00572
OG006113
Title
Denominators
Categories
Title
Measurements
OG00021.7
OG00168.0
OG00215.7
OG00380.2
OG00483.8
OG00513.9
OG00670.8
OG003
TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
OG004
TDF 120 Weeks
TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
OG005
Peg-IFN 48 Weeks (Not Retreated)
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
OG006
Peg-IFN 48 Weeks (Retreated)
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Units
Counts
Participants
OG00074
OG001112
OG00269
OG003115
OG004185
OG00568
OG006117
Title
Denominators
Categories
Title
Measurements
OG00032.4
OG00181.3
OG00218.8
OG00383.5
OG00482.2
OG00513.2
OG00682.1
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
OG003
TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
OG004
TDF 120 Weeks
TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
OG005
Peg-IFN 48 Week (Not Retreated)
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
OG006
Peg-IFN 48 Weeks (Retreated)
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Units
Counts
Participants
OG000126
OG00160
OG002118
OG00366
OG004185
OG005120
OG00665
Title
Denominators
Categories
AASLD Criteria
Title
Measurements
OG00042.1
OG00118.3
OG00240.7
OG00318.2
OG00447.6
OG00535.0
OG0069.2
Central Laboratory Criteria
Title
Measurements
OG00059.5
OG00140.0
OG00257.6
OG003
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
OG003
TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
OG004
TDF 120 Weeks
TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
OG005
Peg-IFN 48 Week (Not Retreated)
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
OG006
Peg-IFN 48 Weeks (Retreated)
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Units
Counts
Participants
OG00081
OG001105
OG00282
OG003102
OG004185
OG00572
OG006113
Title
Denominators
Categories
AASLD Criteria
Title
Measurements
OG00043.2
OG00142.9
OG00234.1
OG00346.1
OG00448.1
OG00534.7
OG00639.8
Central Laboratory Criteria
Title
Measurements
OG00055.6
OG00171.4
OG00252.4
OG003
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
OG003
TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
OG004
TDF 120 Weeks
TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
OG005
Peg-IFN 48 Week (Not Retreated)
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
OG006
Peg-IFN 48 Weeks (Retreated)
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.