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Induction dose of infliximab followed by combination of pegylated interferon alfa-2b and ribavirin

Phase 3

Hepatitis C, Chronic | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Aug 26, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment89

FDA Designations

No designations recorded

Clinical trial landscape

Induction dose of infliximab followed by combination of pegylated interferon alfa-2b and ribavirin · 1 trial · 1 indication

Phase 3 1
NCT00237484Effect of Infliximab on the Efficacy of Peg-Intron/Ribavirin in Patients With Hepatitis C (Study P04257AM4)(COMPLETED)Hepatitis C, Chronic
COMPLETED89 Analytics
PHASE3COMPLETED
Effect of Infliximab on the Efficacy of Peg-Intron/Ribavirin in Patients With Hepatitis C (Study P04257AM4)(COMPLETED)
Hepatitis C, Chronic
NCT0023748489
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Study Endpoints

Primary Endpoints

Proportion of subjects who have achieved sustained virological response (SVR) in the infliximab (induction dose) plus PEGETRON and the PEGETRON groups at 24 weeks post treatment end
24 weeks after completion of up to 48 weeks of PEGETRON therapy

Secondary Endpoints

Early virological response (EVR)
Week 12 of PEGETRON treatment period
Safety parameters
During 48-week PEGETRON treatment period and 24-week follow up
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm AEXPERIMENTALRemicade induction dose at Day -7 prior to initiation of PEGETRON treatment for up to 48 weeks
Arm BACTIVE_COMPARATORPEGETRON treatment for up to 48 weeks

Interventions

NameTypeDescription
Induction dose of (a) infliximab followed by combination of (b) pegylated interferon alfa-2b and (c) ribavirinDRUG1. 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
Combination of (a) pegylated interferon alfa-2b and (b) ribavirinDRUG1. 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
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent. * Subjects must be 18 to 65 years of age. * HCV genotype 1 (including mixtures of subtypes of genotype 1). * Naïve to interferon (any f...

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