A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or Entecavir in Patients With HBeAg-Positive Chronic Hepatitis B
A Randomized, Open-label Study of the Effect of Peginterferon Alfa-2a (40KD)(PEGASYS) in Combination With Adefovir or Entecavir on HBeAg Seroconversion in Patients With HBeAg Positive Chronic Hepatitis B
1 other identifier
interventional
280
1 country
9
Brief Summary
This 3 arm study will assess the efficacy and safety of PEGASYS alone, or in combination with Adefovir or Entecavir in patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly for 48 weeks + placebo from weeks -4 to 2;2)PEGASYS 180 micrograms sc weekly for 48 weeks + Adefovir from weeks -4 to 2; or 3)PEGASYS 180 micrograms sc weekly for 48 weeks + Entecavir from weeks -4 to 2. Treatment will be followed by 24 weeks of treatment-free follow-up.The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2010
Longer than P75 for phase_4
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2009
CompletedFirst Posted
Study publicly available on registry
June 17, 2009
CompletedStudy Start
First participant enrolled
May 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2014
CompletedResults Posted
Study results publicly available
November 20, 2015
CompletedApril 10, 2017
March 1, 2017
4.4 years
June 16, 2009
October 20, 2015
March 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment
HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of hepatitis B e-antibody (anti-HBe/HBeAb) (a positive result for anti-HBe).
Week 100
Secondary Outcomes (6)
Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Percentage of Participants Who Were HBeAg Negative
Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive
Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels
Baseline, Weeks 6, 12, 16, 22, 28, 34, 40, 46, 52, 64, 76, 88, and 100
Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
- +1 more secondary outcomes
Study Arms (3)
1
EXPERIMENTAL2
EXPERIMENTAL3
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- adult patients, 18-65 years of age;
- HBeAg+ve for \>=3 months;
- positive serum HBV DNA within 3 months prior to entry;
- patients with chronic hepatitis B, either naive to HBV treatment, or not responded/relapsed to nucleoside analogues;
- \>=3 months treatment-free interval from nucleotide analogues.
You may not qualify if:
- evidence of decompensated liver disease;
- history or other evidence of a medical condition associated with chronic liver disease othr than viral hepatitis;
- co-infection with active hepatitis A,C or D, or HIV.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Changhua Christian Hospital; Internal Medicine
Changhua, 500, Taiwan
Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine
Kaohsiung City, 00833, Taiwan
Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine
Kaohsiung City, 807, Taiwan
Chang Gung Medical Foundation - Keelung; Dept. of Hepato-Gastroenterology
Keelung, 204, Taiwan
China Medical University Hospital; Department of Rheumatology
Taichung, 404, Taiwan
National Taiwan Uni Hospital; Gastro-Enterology Dept.
Taipei, 100, Taiwan
Taipei Veterans General Hospital; Gastroenterology Division
Taipei, 112, Taiwan
Tri-Service Hospital; Dept. of Internal Medicine
Taipei, Taiwan
Chang Gung Medical Foundation - Linkou; Dept. of Hepato-Gastroenterology
Taoyuan District, 333, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- HoffmannLa Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2009
First Posted
June 17, 2009
Study Start
May 7, 2010
Primary Completion
September 29, 2014
Study Completion
September 29, 2014
Last Updated
April 10, 2017
Results First Posted
November 20, 2015
Record last verified: 2017-03