Status:
TERMINATED
An Observational Study on the Prevalence of Chronic Hepatitis D in Romania and the Efficacy of Treatment With Pegasys (Peginterferon Alfa-2a)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis D, Chronic
Eligibility:
All Genders
18+ years
Brief Summary
This prospective, multicenter, observational study will assess the prevalence of chronic hepatitis D in patients with chronic hepatitis B in Romania and evaluate the efficacy of Pegasys (peginterferon...
Eligibility Criteria
Inclusion
- For epidemiological part of the study:
- Adult patients \>/= 18 years of age
- Positive HBsAg for at least 6 months
- For the non-interventional section of the study
- Adult patients, \>/= 18 years of age
- Positive HBsAg for at least 6 months
- Positive anti-delta and positive HDV RNA by PCR
- Elevated serum ALT \>/= 2x ULN
Exclusion
- Patients with any of the following will not be eligible for treatment with Pegasys:
- History of neurological disease
- History of severe psychiatric disease
- Decompensated diabetes
- History of immunologically mediated disease
- History of severe cardiac disease
- History or other evidence of severe chronic pulmonary disease
- Inadequate hematologic function
Key Trial Info
Start Date :
March 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01861444
Start Date
March 1 2011
End Date
March 1 2015
Last Update
November 2 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Bucharest, Romania, 022328