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Three Regimens of PegIntron Plus Ribavirin in Previously Untreated Chronic Hepatitis C, Genotype 2 or 3 (Study P03548)

NCT00302081 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 696

Last updated 2017-04-05

Study results available
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Summary

This is a randomized, open-label, multinational study designed to evaluate the "standard" regimen, PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily \[Arm PEG2b 1.5/R (24 weeks)\], compared to a lower dose regimen, PegIntron 1.0 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily \[Arm PEG2b 1.0/R (24 weeks)\], using a 24 week treatment duration for both arms. Additionally, the study examined the efficacy of reduced treatment duration: PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg for 16 weeks \[Arm PEG2b 1.5/R (16 weeks)\] .

Conditions

  • Hepatitis C, Chronic

Interventions

BIOLOGICAL

peginterferon alfa-2b (SCH 54031)

1.5 mcg/kg QW SC for 24 weeks

BIOLOGICAL

peginterferon alfa-2b (SCH 54031)

1.0 mcg/kg QW SC for 24 weeks

BIOLOGICAL

peginterferon alfa-2b (SCH 54031)

1.5 mcg/kg QW SC for 16 weeks

DRUG

ribavirin (SCH 18908)

800-1200 mg daily for 24 weeks

DRUG

ribavirin (SCH 18908)

800-1200 mg daily for 16 weeks

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2008-04-30
Completion
2008-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00302081 on ClinicalTrials.gov