Back to resultsA Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies
Primary Purpose
Hepatitis B, Chronic
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
peginterferon alfa-2a [Pegasys]
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
- previous participation in other donor protocol
- chronic hepatitis B
- no other anti-HBV treatment after completion of previous donor protocol
- female patients and female partners of male patients must use at least two methods of contraception until 28 days after completion of study
Exclusion Criteria:
- hepatic decompensation (Child-Pugh class B and C)
- antiviral, antineoplastic or immunomodulatory treatment
- evidence of alcohol and/or drug abuse
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
Primary Outcome Measures
The longitudinal effect on HBV-related markers: viral load, viral antigen/antibody, viral sequence, cellular and humoral immune responses, RNA
Secondary Outcome Measures
Safety and tolerability: AEs, laboratory parameters, vital signs, concomitant medications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00962975
Brief Title
A Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
In this open-label multicenter study the long-term effect of Pegasys monotherapy on pharmacodynamic HBV-related markers will be investigated in patients with chronic hepatitis B. Eligible patients will have completed treatment on another donor protocol (e.g. PP22512) and will receive Pegasys at an appropriate dose based on the standard of care (180mcg sc once weekly) for up to 48 weeks. Target sample size is <100.
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 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
dosage at discretion of investigator based on standard of care (180mcg sc weekly) for up to 48 weeks
Primary Outcome Measure Information:
Title
The longitudinal effect on HBV-related markers: viral load, viral antigen/antibody, viral sequence, cellular and humoral immune responses, RNA
Time Frame
assessed every 2 months on treatment (not exceeding maximum approved duration), and up to week 24 of follow-up
Secondary Outcome Measure Information:
Title
Safety and tolerability: AEs, laboratory parameters, vital signs, concomitant medications
Time Frame
assessed every 2 months on treatment and up to week 24 of follow-up
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
previous participation in other donor protocol
chronic hepatitis B
no other anti-HBV treatment after completion of previous donor protocol
female patients and female partners of male patients must use at least two methods of contraception until 28 days after completion of study
Exclusion Criteria:
hepatic decompensation (Child-Pugh class B and C)
antiviral, antineoplastic or immunomodulatory treatment
evidence of alcohol and/or drug abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0538
Country
United States
City
Grafton
ZIP/Postal Code
1010
Country
New Zealand
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
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A Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies
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