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

Phase 1

Completed

• Conditions: Hepatitis B, Chronic
• Interventions: Drug: peginterferon alfa-2a [Pegasys]

• Registration Number: NCT00962975
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-19
• Study First Submitted QC: 2009-08-19
• Study First Posted: 2009-08-20
• Study Start: 2009-09
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-07
• Last Update Posted: 2014-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	peginterferon alfa-2a [Pegasys]	-

Primary Outcome Measures

Name	Time	Method
The longitudinal effect on HBV-related markers: viral load, viral antigen/antibody, viral sequence, cellular and humoral immune responses, RNA	assessed every 2 months on treatment (not exceeding maximum approved duration), and up to week 24 of follow-up

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability: AEs, laboratory parameters, vital signs, concomitant medications	assessed every 2 months on treatment and up to week 24 of follow-up