Status:
COMPLETED
Genetic Study of Peginterferon Treatment in Hepatitis B Patients: The GIANT-B Study
Lead Sponsor:
Foundation for Liver Research
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18+ years
Brief Summary
Background and rationale Chronic hepatitis B is the most common cause of liver cirrhosis and hepatocellular carcinoma worldwide.(1) Antiviral therapy with oral nucleoside analogs and interferon can re...
Detailed Description
For the GWAS stage of this study, a cohort study will be conducted comparing hepatitis B patients with a response (see definitions below) versus patients who did not achieve a response to (peg)interfe...
Eligibility Criteria
Inclusion
- Inclusion criteria
- History of chronic hepatitis B, defined as the presence of positive hepatitis B surface antigen (HBsAg) for at least 6 months.
- History of treatment (per protocol or outside studies) with standard interferon (alfa-2a or alfa-2b), peginterferon alfa-2a or peginterferon alfa-2b for at least 12 weeks.
- A follow-up duration of at least 24 weeks after the last dose of (peg)interferon.
- Use of nucleos(t)ide analogues prior to or combined with (peg)interferon treatment is allowed.
- Available HBV DNA and HBeAg status at baseline, end of treatment and end of follow-up (24 weeks after end of treatment)
- Written informed consent obtained.
- Exclusion criteria
- Co-infection with hepatitis C virus, delta virus or human immunodeficiency virus.
- Use of immunosuppressants, chemotherapy or systemic corticosteroids (prednisolone 30 mg daily or equivalent for more than 7 days) during (peg)interferon treatment or the 24-week pre- and post-treatment period.
Exclusion
Key Trial Info
Start Date :
May 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
1350 Patients enrolled
Trial Details
Trial ID
NCT01401400
Start Date
May 1 2010
End Date
June 1 2015
Last Update
August 14 2015
Active Locations (1)
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1
Erasmus Medical Centre
Rotterdam, South Holland, Netherlands, 3015 GE