Study of Patients With Chronic Hepatitis C Infected With HCV LVL G1 and Effect of Peg-Intron Plus Rebetol Treatment (Study P04793)

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

496 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-11-30

Brief Summary

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To determine the relapse rate at 24 weeks follow up in Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) patients treated for 24 weeks with Peg Intron and Rebetol who are Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) negative at treatment week 4 and week 24. To determine the proportion of patients (%) with sustained virological response at 24 weeks post follow up treatment.

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Detailed Description

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Approximately 500 patients from about 100 sites to be identified as HCV LVL G1 patients

Conditions

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Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PegIntron plus Rebetol

Those with chronic Hepatitis C infected with HCV LVL G1

PegIntron

Intervention Type DRUG

1.5 ug/kg/week

Rebetol

Intervention Type DRUG

800-1200 mg/day

Interventions

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PegIntron

1.5 ug/kg/week

Intervention Type DRUG

Rebetol

800-1200 mg/day

Intervention Type DRUG

Other Intervention Names

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SCH 054031 SCH 18908

Eligibility Criteria

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Inclusion Criteria

* Willingness to participate
* 18 years or older, either gender, any race
* Must have Hepatitic C Virus Low Viral Load \[LCV LVL\] (positive, but \<600,000 IU/mL on the assay used by the individual study site. Only Hepatitis C Virus-Ribonucleic acid/quantitative polymerase chain reaction \[HCV-RNA/qPCR\] assays with results in IU/ml are acceptable) AND been diagnosed with Genotype 1
* Subject considered suitable for treatment per local label
* Investigator considers suitable and subject consents to be treated

Exclusion Criteria

* Does not show negative polymerase chain reaction \[PCR\] at week 4
* Pregnant women or those who plan to become pregnant or sexual partners of women who plan to become pregnant
* Subject does not qualify based on contra-indication, special warning, special population, and/or pregnancy \& lactation section of the Summary of Product Characteristics \[SmPC\]

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No