Back to resultsA Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B.
Primary Purpose
Hepatitis B, Chronic
Status
Terminated
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
peginterferon alfa-2a (40KD) [PEGASYS]
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B, Chronic
Eligibility Criteria
Inclusion Criteria:
- adult patients, 18-65 years of age;
- HBeAg negative chronic hepatitis B;
- treated with lamivudine for >=6 months;
- demonstrated lamivudine resistance;
- compensated liver disease.
Exclusion Criteria:
- severe hepatic dysfunction;
- previous treatment with antivirals other than lamivudine;
- immunosuppressant treatment in past 6 months;
- co-infection with hepatitis A, C, or D virus or human immunodeficiency virus;
- medical condition associated with chronic liver disease.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Normalization of ALT, and HBV-DNA <10,000 copies/mL
Secondary Outcome Measures
Normalization of ALT, and HBV-DNA <10,000 copies/mL
HBsAg loss and anti-HBs seroconversion
AEs and lab parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00460850
Brief Title
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B.
Official Title
An Open Label Study to Evaluate the Effect of PEGASYS on ALT and HBV DNA Levels in Patients With Lamivudine-Resistant HbeAg-Negative Chronic Hepatitis B
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment rate due to treatment regimen change
Study Start Date
September 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This single arm study will evaluate the efficacy and safety of PEGASYS in patients with lamivudine resistant HBeAg negative chronic hepatitis B. Patients will receive PEGASYS 180 micrograms s.c. weekly for 48 weeks; following this, there will be a 48 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a (40KD) [PEGASYS]
Intervention Description
180 micrograms sc weekly for 48 weeks
Primary Outcome Measure Information:
Title
Normalization of ALT, and HBV-DNA <10,000 copies/mL
Time Frame
Week 96
Secondary Outcome Measure Information:
Title
Normalization of ALT, and HBV-DNA <10,000 copies/mL
Time Frame
Weeks 48 and 72
Title
HBsAg loss and anti-HBs seroconversion
Time Frame
Weeks 48, 72 and 96
Title
AEs and lab parameters
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients, 18-65 years of age;
HBeAg negative chronic hepatitis B;
treated with lamivudine for >=6 months;
demonstrated lamivudine resistance;
compensated liver disease.
Exclusion Criteria:
severe hepatic dysfunction;
previous treatment with antivirals other than lamivudine;
immunosuppressant treatment in past 6 months;
co-infection with hepatitis A, C, or D virus or human immunodeficiency virus;
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
Facility Information:
City
Ankara
ZIP/Postal Code
06620
Country
Turkey
City
Antalya
ZIP/Postal Code
07058
Country
Turkey
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
City
Izmir
ZIP/Postal Code
35360
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B.
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