A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With 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

NCT00487747

ML20003

Details and patient eligibility

About

This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis B who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past. All patients will receive PEGASYS, 180 micrograms s.c. weekly for 48 weeks, followed by 48 weeks of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Enrollment: 18 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, 18-70 years of age;
• chronic hepatitis B;
• Hepatitis B Virus (HBV) DNA >100,000 copies/mL.

Exclusion criteria

• previous antiviral or interferon-based therapy for chronic hepatitis B in past 6 months;
• evidence of decompensated liver disease;
• history or evidence of a medical condition associated with chronic liver disease other than viral hepatitis;
• coinfection with hepatitis A, C or D, or HIV.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Peginterferon Alfa-2a

Experimental group

Treatment:

Drug: peginterferon alfa-2a [Pegasys]