A Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies

Roche

Status and phase: Completed; Phase 1

Conditions: Hepatitis B, Chronic

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00962975

PP22612

Details and patient eligibility

About

In this open-label multicenter study the long-term effect of Pegasys monotherapy on pharmacodynamic HBV-related markers will be investigated in patients with chronic hepatitis B. Eligible patients will have completed treatment on another donor protocol (e.g. PP22512) and will receive Pegasys at an appropriate dose based on the standard of care (180mcg sc once weekly) for up to 48 weeks. Target sample size is <100.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients >/=18 years of age
• previous participation in other donor protocol
• chronic hepatitis B
• no other anti-HBV treatment after completion of previous donor protocol
• female patients and female partners of male patients must use at least two methods of contraception until 28 days after completion of study

Exclusion criteria

• hepatic decompensation (Child-Pugh class B and C)
• antiviral, antineoplastic or immunomodulatory treatment
• evidence of alcohol and/or drug abuse

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Single Arm

Experimental group

Treatment:

Drug: peginterferon alfa-2a [Pegasys]