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Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471)

NCT00081770 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4469

Last updated 2017-04-04

Study results available
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Summary

The objective is to compare the safety and efficacy of the following three treatment regimens in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1) PegIntron 1.5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2) PegIntron 1µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); and (3) PEGASYS 180 µg/wk plus COPEGUS 1000-1200 mg/day.

Conditions

  • Hepatitis C, Chronic

Interventions

BIOLOGICAL

PegIntron (peginterferon alfa-2b; SCH 54031)

1.5 ug/kg/week subcutaneously (SC) for 48 weeks

BIOLOGICAL

PegIntron (peginterferon alfa-2b; SCH 54031)

1.0 ug/kg/week SC for 48 weeks

DRUG

REBETOL (ribavirin; SCH 18908)

weight based dose 800-1400 mg/day orally (PO) for 48 weeks

BIOLOGICAL

PEGASYS (peginterferon alfa-2a)

180 ug/week SC administered for 48 weeks

DRUG

COPEGUS (ribavirin)

1000-1200 mg/day PO for 48 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
2004-03-31
Primary Completion
2007-11-30
Completion
2007-11-30

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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 NCT00081770 on ClinicalTrials.gov