Study Stopped
This study was canceled for operational reasons.
A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B.
A Phase IV, 2x2 Factorial, Double Blind Study of 48 Versus 96 Weeks of PEGASYS 180µg, With or Without 24 Weeks of Entecavir in Adult Patients With HBeAg Negative Chronic Hepatitis B.
2 other identifiers
interventional
N/A
0 countries
N/A
Brief Summary
This randomized, 2 x 2 factorial, parrallel group study will compare the efficacy and safety of 48 versus 96 weeks of peginterferon alfa-2a \[Pegasys\], with or without entecavir, in patients with HbeAg negative chronic hepatitis B. Patients will be randomly allocated to receive Pegasys (180mcg subcutaneously weekly) for 48 weeks plus placebo (group A) or entecavir (0,5mg orally daily, group B) during weeks 12-36, or Pegasys (180mcg subcutaneously weekly) for 96 weeks plus placebo (group C) or entecavir (group D) during weeks 12-36. Anticipated time on study treatment is 48 or 96 weeks, with a follow-up of 48 weeks. Target sample size is \<500 patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2010
Longer than P75 for phase_4
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
August 10, 2010
CompletedFirst Posted
Study publicly available on registry
August 11, 2010
CompletedStudy Start
First participant enrolled
September 18, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedFebruary 17, 2017
February 1, 2017
4.1 years
August 10, 2010
February 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy: HBV-DNA reduction to <10,000 copies/ml (<2,000 IU/ml)
48 weeks after the end of treatment
Secondary Outcomes (1)
Correlation early HBsAg response - response end of treatment/follow-up
every 6 weeks up to week 48, every 12 weeks therafter
Study Arms (4)
A
PLACEBO COMPARATORB
EXPERIMENTALC
PLACEBO COMPARATORD
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- adult patients, \>/= 18 years of age
- chronic hepatitis B for \>/= 6 months
- HBeAg negative at screening
- adequate renal function
You may not qualify if:
- antiviral therapy for chronic hepatitis B within the previous 6 months
- hepatitis A, C, D or HIV infection
- treatment with systemic acyclovir or famciclovir within the previous 6 months
- decompensated liver disease (Childs B-C)
- history or evidence of a medical condition associated with chronic liver disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2010
First Posted
August 11, 2010
Study Start
September 18, 2010
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
February 17, 2017
Record last verified: 2017-02