An Observational Study on the Prevalence of Chronic Hepatitis D in Romania and the Efficacy of Treatment With Pegasys (Peginterferon Alfa-2a)

Terminated

• Conditions: Hepatitis D, Chronic

• Registration Number: NCT01861444
• Lead Sponsor: Hoffmann-La Roche

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 alfa-2a) in patients with chronic hepatitis D. Eligible patients treated with Pegasys according to current medical practice will be followed until 24 weeks after the end of treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2013-05-02
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-23
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

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 Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate: Proportion of patients achieving ALT normalization and HDV RNA negativity 24 weeks after the end of treatment	approximately 3.5 years
Proportion of chronic hepatitis B patients in Romania with chronic hepatitis D infection	approximately 3.5 years

Secondary Outcome Measures

Name	Time	Method
Virological characteristics (HBeAg/anti-HBe/HBV DNA/anti-HDV Ab/HDV RNA) of patients with chronic hepatitis D	approximately 3.5 years
Proportion of chronic hepatitis D patients with liver cirrhosis	approximately 3.5 years