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

Roche

Status and phase: Completed; Phase 4

Conditions: Hepatitis B, Chronic

Treatments: Drug: peginterferon alfa-2a [Pegasys]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01519921

ML18495

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, 18-65 years of age
• HBsAg +ve for more than 6 months, HBeAg +ve, AntiHBs -ve
• Detectable hepatitis B virus (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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

PEG-IFN alfa-2a (Treatment naïve)

Experimental group

Description:

Eligible treatment naïve participants received peginterferon alfa-2a (PEGASYS) 180 micrograms (mcg) subcutaneously (SC) once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

PEG-IFN alfa-2a (YMDD mutant)

Experimental group

Description:

Eligible tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.

Treatment:

Drug: peginterferon alfa-2a [Pegasys]