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

NCT ID: NCT00962975

Last Updated: 2014-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-05-31

Brief Summary

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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

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Conditions

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Hepatitis B, Chronic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

Group Type EXPERIMENTAL

peginterferon alfa-2a [Pegasys]

Intervention Type DRUG

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

Interventions

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peginterferon alfa-2a [Pegasys]

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Los Angeles, California, United States

Site Status

San Francisco, California, United States

Site Status

Grafton, , New Zealand

Site Status

Singapore, , Singapore

Site Status

Singapore, , Singapore

Site Status

Taipei, , Taiwan

Site Status

Countries

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United States New Zealand Singapore Taiwan

Other Identifiers

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PP22612

Identifier Type: -

Identifier Source: org_study_id

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