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

PHASE3CompletedINTERVENTIONAL
Enrollment

89

Participants

Timeline

Start Date

July 18, 2005

Primary Completion Date

June 30, 2011

Study Completion Date

June 30, 2011

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"

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT00237484 - Effect of Infliximab on the Efficacy of Peg-Intron/Ribavirin in Patients With Hepatitis C (Study P04257AM4)(COMPLETED) | Biotech Hunter | Biotech Hunter