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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B.

NCT ID: NCT00460850

Last Updated: 2008-06-30

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-06-30

Brief Summary

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This single arm study will evaluate the efficacy and safety of PEGASYS in patients with lamivudine resistant HBeAg negative chronic hepatitis B. Patients will receive PEGASYS 180 micrograms s.c. weekly for 48 weeks; following this, there will be a 48 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

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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1

Group Type EXPERIMENTAL

peginterferon alfa-2a (40KD) [PEGASYS]

Intervention Type DRUG

180 micrograms sc weekly for 48 weeks

Interventions

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peginterferon alfa-2a (40KD) [PEGASYS]

180 micrograms sc weekly for 48 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, 18-65 years of age;
* HBeAg negative chronic hepatitis B;
* treated with lamivudine for \>=6 months;
* demonstrated lamivudine resistance;
* compensated liver disease.

Exclusion Criteria

* severe hepatic dysfunction;
* previous treatment with antivirals other than lamivudine;
* immunosuppressant treatment in past 6 months;
* co-infection with hepatitis A, C, or D virus or human immunodeficiency virus;
* medical condition associated with chronic liver disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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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Hoffmann-La Roche

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Ankara, , Turkey (Türkiye)

Site Status

Antalya, , Turkey (Türkiye)

Site Status

Istanbul, , Turkey (Türkiye)

Site Status

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ML20135

Identifier Type: -

Identifier Source: org_study_id