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Effect of Infliximab on the Efficacy of Peg-Intron/Ribavirin in Patients With Hepatitis C (Study P04257AM4)(COMPLETED)

NCT00237484 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2020-08-26

No results posted yet for this study

Summary

This is a Phase IIIB, randomized, prospective, multicenter, single-country, open-label, controlled pilot trial designed to evaluate the effect of infliximab induction therapy on sustained virologic response (SVR) to treatment with pegylated interferon alfa-2b plus ribavirin in a group of 96 therapy-naïve subjects with genotype 1 hepatitis C virus (HCV) infection and high serum tumor necrosis factor (TNF)-alpha values.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

Induction dose of (a) infliximab followed by combination of (b) pegylated interferon alfa-2b and (c) ribavirin

1. Powder for intravenous infusion (100 mg strength), intravenous, single dose of 5 mg/kg, at Day -7, prior to initiation of the following combination therapy: 2. powder for injection in vials or Redipen (80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks 3. 200 mg capsules, oral, dose of 800-1400 mg (weight based dosing as per PEGETRON Product Monograph), daily for up to 48 weeks

DRUG

Combination of (a) pegylated interferon alfa-2b and (b) ribavirin

1. Powder for injection in vials or Redipen (80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks 2. 200 mg capsules, oral, dose of 800-1400 mg (weight based dosing as per PEGETRON Product Monograph), daily for up to 48 weeks

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-07-18
Primary Completion
2011-06-30
Completion
2011-06-30

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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 NCT00237484 on ClinicalTrials.gov