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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B.

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B, Chronic

Intervention: peginterferon alfa-2a [Pegasys] (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Chair, Affiliation: Hoffmann-La Roche

Summary

This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in patients with HBeAg positive chronic hepatitis B. Patients will be stratified into group A (treatment na´ve patients) or B (YMDD mutant patients). All patients will receive PEGASYS 180 micrograms subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow up.

Clinical Details

Official title: An Open Label Phase IV Multicenter Study for Efficacy and Safety of Peginterferon Alfa-2a (40KD) (PEGASYS«) in Patients With HBeAg Positive Chronic Hepatitis B

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Percentage of patients with hepatitis B virus DNA <100,000 copies/mL

Percentage of patients with hepatitis B virus HBeAg loss rate

Secondary outcome:

Percentage of patients with alanine aminotransferase (ALT) normalization

Percentage of patients with hepatitis B virus (HBV) DNA below limit of detection

Percentage of patients with a combined response of HBeAg seroconversion, loss of HBeAg, and alanine aminotransferase normalization

Percentage of patients with HBeAg seroconversion

Percentage of patients with loss of HBsAg

Percentage of patients with loss of HBsAg and presence of anti-HBs

Safety: Incidence of adverse events

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adult patients, 18-65 years of age

- HBsAg +ve for more than 6 months, HBeAg +ve, AntiHBs -ve

- Detectable HBV DNA (>100,000 copies/mL)

Exclusion Criteria:

- Coinfection with hepatitis A, hepatitis C or human immunodeficiency virus (HIV)

- Evidence of decompensated liver disease

- A medical condition associated with chronic liver disease other than viral hepatitis

Locations and Contacts

Daegu 700-721, Korea, Republic of

Seoul 110-744, Korea, Republic of

Seoul 135-710, Korea, Republic of

Seoul 138-736, Korea, Republic of

Seoul, Korea, Republic of

Additional Information

Starting date: October 2005
Last updated: August 17, 2015

Page last updated: August 23, 2015

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