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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT00962975

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

4.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B, Chronic	Drug: peginterferon alfa-2a [Pegasys]	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Arm	Drug: peginterferon alfa-2a [Pegasys] dosage at discretion of investigator based on standard of care (180mcg sc weekly) for up to 48 weeks

Arm

Intervention/Treatment

Experimental: Single Arm

Drug: peginterferon alfa-2a [Pegasys]

dosage at discretion of investigator based on standard of care (180mcg sc weekly) for up to 48 weeks

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Los Angeles	California	United States	90036
2	San Francisco	California	United States	94143-0538
3	Grafton		New Zealand	1010
4	Singapore		Singapore	119228
5	Singapore		Singapore	169608
6	Taipei		Taiwan	100