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 naïve 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/mLPercentage of patients with hepatitis B virus HBeAg loss rate
Secondary outcome: Percentage of patients with alanine aminotransferase (ALT) normalizationPercentage 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
|