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

Hepatitis D, Chronic Clinical Trial

Official title:

National, Multicenter, Observational Study Evaluating Prevalence, Virological and Clinical Characteristics of Chronic Hepatitis Delta in Romania and Assess Efficacy of Peg-interferon Alfa-2a Treatment in Patients With Chronic Hepatitis D (CHD)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01861444
• Other study ID #: ML25581
• Status: Terminated
• Phase: N/A
• First received: May 2, 2013
• Last updated: November 1, 2016
• Start date: March 2011
• Est. completion date: March 2015

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Medicines Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis D
• Hepatitis D, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of chronic hepatitis B patients in Romania with chronic hepatitis D infection		approximately 3.5 years	No
Primary	Response rate: Proportion of patients achieving ALT normalization and HDV RNA negativity 24 weeks after the end of treatment		approximately 3.5 years	No
Secondary	Virological characteristics (HBeAg/anti-HBe/HBV DNA/anti-HDV Ab/HDV RNA) of patients with chronic hepatitis D		approximately 3.5 years	No
Secondary	Proportion of chronic hepatitis D patients with liver cirrhosis		approximately 3.5 years	No