A Study of PEGASYS (Peginterferon Alfa-2a [40KD]) in Patients With Hepatitis B e Antigen (HBeAg)-Negative Chronic Hepatitis B Virus (HBV)

Phase 4

Completed

• Conditions: Hepatitis B, Chronic
• Interventions: Drug: Peginterferon alfa-2a

• Registration Number: NCT02570191
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This study will evaluate the efficacy, safety, and tolerability of PEGASYS in participants with HBeAg-negative chronic HBV. The anticipated time on study treatment is 48 weeks, and the target sample size is 60 individuals.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Study First Submitted: 2015-10-05
• Study First Submitted QC: 2015-10-05
• Study First Posted: 2015-10-07
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Adult participants 18-70 years of age
• Positive test result for HBsAg for >6 months
• Naive to treatment for HBV
• On liver biopsy, liver disease consistent with chronic HBV, with or without compensated cirrhosis

Exclusion Criteria

• Co-infection with hepatitis A, C or D, or with Human Immunodeficiency Virus (HIV)
• Decompensated liver disease
• Hepatocellular cancer
• Systemic anti-viral, anti-neoplastic, or immunomodulatory therapy less than or equal to 6 months before study drug
• Medical condition associated with chronic liver disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peginterferon alfa-2a	Peginterferon alfa-2a	Participants received 180 micrograms (uG) of Pegasys (0.5 milliliter \[mL\] solution) once a week subcutaneously for 48 weeks.

Primary Outcome Measures

Name	Time	Method
Efficacy: Hepatitis B Virus - Deoxy ribonucleic acid (HBV-DNA) less than (<)20,000 Copies per milliliter (copies/mL) At End of Follow-Up	72 Weeks
Alanine Transaminase (ALT) Normalization at the End of Follow-Up	72 Weeks

Secondary Outcome Measures

Name	Time	Method
HBV DNA Suppression <20000 Copies/mL at the End of Treatment	48 Weeks
Alanine Transaminase (ALT) Normalization at the End of Treatment	48 Weeks
Efficacy: Loss of Hepatitis B Virus Antigen ( HBsAg) and Seroconversion at End of Follow-Up	72 Weeks
Hepatitis B Virus (HBV) DNA Below the Limit of Quantification At the End of Follow-Up	72 Weeks