Back to resultsA Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B.
Primary Purpose
Hepatitis B, Chronic
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
entecavir
peginterferon alfa-2a [Pegasys]
peginterferon alfa-2a [Pegasys]
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B, Chronic
Eligibility Criteria
Inclusion Criteria:
- adult patients, >/= 18 years of age
- chronic hepatitis B for >/= 6 months
- HBeAg negative at screening
- adequate renal function
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Arm Label
A
B
C
D
Arm Description
Outcomes
Primary Outcome Measures
Efficacy: HBV-DNA reduction to <10,000 copies/ml (<2,000 IU/ml)
Secondary Outcome Measures
Correlation early HBsAg response - response end of treatment/follow-up
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01179594
Brief Title
A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B.
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Withdrawn
Why Stopped
This study was canceled for operational reasons.
Study Start Date
September 18, 2010 (Anticipated)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Placebo Comparator
Arm Title
B
Arm Type
Experimental
Arm Title
C
Arm Type
Placebo Comparator
Arm Title
D
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
entecavir
Intervention Description
0.5 mg orally daily, 24 weeks (weeks 12-36)
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
180 mcg sc weekly, 48 weeks
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
180 mcg sc weekly, 96 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
orally daily, 24 weeks (weeks 12-36)
Primary Outcome Measure Information:
Title
Efficacy: HBV-DNA reduction to <10,000 copies/ml (<2,000 IU/ml)
Time Frame
48 weeks after the end of treatment
Secondary Outcome Measure Information:
Title
Correlation early HBsAg response - response end of treatment/follow-up
Time Frame
every 6 weeks up to week 48, every 12 weeks therafter
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients, >/= 18 years of age
chronic hepatitis B for >/= 6 months
HBeAg negative at screening
adequate renal function
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B.
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