An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HbeAg-negative Chronic Hepatitis B (Perseas)

Hepatitis B, Chronic Clinical Trial

Official title:

Prognostic Factors of Long-term Response to Treatment With Pegylated Interferon Alfa-2a in Patients With HbeAg-negative Chronic Hepatitis B. (Perseas)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01283074
• Other study ID #: ML22016
• Status: Completed
• Phase: N/A
• First received: January 24, 2011
• Last updated: November 1, 2016
• Start date: May 2009
• Est. completion date: November 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Observational

Clinical Trial Summary

This observational, multi-center, open-label study will evaluate the prognostic factors of long-term-response and the safety of Pegasys (peginterferon alfa-2a) in patients with HbeAg-negative chronic hepatitis B. Data will be collected for 96 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/=18 years of age

• Diagnosis of HBeAg-negative chronic hepatitis B with compensated hepatic disease, virus multiplication, raised alanine amino transferase results and/or fibrosis

Exclusion Criteria:

• Co-infection with hepatitis A, C or D

• Co-infection with human immunodeficiency virus (HIV)

• Severe hepatic dysfunction or decompensated liver disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with combined (virological and biochemical) response		48 weeks after end of treatment	No
Secondary	Normalization of serum alanine aminotransferase		12 months	No
Secondary	Safety (Incidence of adverse events)		12 months	No