NCT00512278CompletedPhase 2
Infliximab (Remicade®) as an Adjunct to Pegylated- Interferon α-2b and Ribavirin in the Treatment of Hepatitis C Virus Infection
Nizar Zein7 sites in 1 country146 target enrollmentStarted: July 2007Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 146
- Locations
- 7
- Primary Endpoint
- A Comparison of the Percentage of Chronic Hepatitis C Subjects (Treatment Naive,Genotype 1) Who Achieve SVR at Week 72, After 48 Weeks of Treatment.
Study Overview
Brief Summary
The aim of the study is to investigate in subjects receiving their first course of peg-interferon α-2b plus ribavirin therapy for chronic HCV infection
Detailed Description
The aim of the study is to investigate in subjects receiving their first course of peg-interferon α-2b plus ribavirin therapy for chronic HCV infection (genotype 1) whether the addition of infliximab to a standard regimen of pegylated interferon α-2b in combination with ribavirin:
- increases the proportion of subjects attaining a sustained virological response SVR (undetectable blood Hepatitis C viral load 6 months after treatment)
- improves the safety profile compared to the same regimen without infliximab
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female subjects, >18 years of age with proven chronic (greater than 6 months) hepatitis C infection (genotype 1) who have never been treated with pegylated interferon α-2b and /or ribavirin.
- •Criteria for inclusion in this trial are as follows:
- •Male or female, 18 years of age or older
- •Positive HCV RNA, Genotype 1, treatment naïve (never received pegylated interferon and / or ribavirin)
- •Evidence of chronic HCV infection for at least six months prior to screening
- •Findings on liver biopsy within the past 36 months that are consistent with the presence of chronic hepatitis C infection.
- •Negative hepatitis B surface antigen
- •No evidence of hemochromatosis
- •Hemoglobin ≥12 g/dL for females and ≥13 g/dL for males
- •WBC ≥3.0 x 109/L and neutrophils ≥1.5 x 109/L
- •Platelets ≥80 x109/L
- •Direct Bilirubin WNL +/- 50% of central laboratory normal range. Total bilirubin ≤1.
- •Albumin within normal limits
- •Serum creatinine within normal limits.
- •Serum thyroid stimulating hormone (TSH) levels within normal limits
- •Men and women of childbearing potential must use two forms of adequate birth control measures for the duration of the study and should continue such precautions for 6 months after receiving the last infusion.
- •Subjects with a history of mild depression may be considered for entry into this study.
- •No history of latent or active TB.
Exclusion Criteria
- •Women who are pregnant, nursing, or planning pregnancy within 6 months after the last infusion and men with partners who are pregnant at baseline or intend to become pregnant within 6 months after the last infusion.
- •Known allergy against infliximab, ribavirin, or pegylated interferon
- •Decompensated liver disease characterized as decreased hepatic synthetic functioning with abnormal albumin and bilirubin levels, prolonged prothrombin time or complications including ascites or recent variceal bleeding
- •have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidiomycosis (Valley Fever)
- •History of autoimmune hepatitis or a history of poorly controlled autoimmune disease
- •Use of other systemic anti-inflammatory medication except NSAIDs and low dose systemic steroids
- •Previous treatment with monoclonal antibodies or antibody fragments
- •History of receiving human/murine recombinant products or a known allergy to murine products
- •Documentation of seropositive for human immunodeficiency virus (HIV)
- •History of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results
- •History of serious infections (e.g., hepatitis, pneumonia or pyelonephritis) in the previous 3 months
- •Opportunistic infection within 6 months prior to screening
- •History of lymphoproliferative disease
- •Currently have any known malignancy or have a history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been fully excised with no evidence of recurrence
- •Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease
- •Treatment with any other therapeutic agent targeted at reducing TNF within 3 months of screening
- •Presence of a transplanted solid organ
- •Concomitant diagnosis or history of congestive heart failure
Arms & Interventions
Infliximab
Experimental
Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab
Intervention: Infliximab (Drug)
Placebo
Placebo Comparator
Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
A Comparison of the Percentage of Chronic Hepatitis C Subjects (Treatment Naive,Genotype 1) Who Achieve SVR at Week 72, After 48 Weeks of Treatment.
Time Frame: 72 Weeks from initiation of treatment
A comparison of the Proportion of Chronic Hepatitis C Subjects (Treatment Naive,Genotype 1) Who Achieve SVR at Week 72, After 48 Weeks of TreatmentSVR in both study arms
Number of Participants Achieving Sustained Virological Response (SVR)
Time Frame: 24 weeks after completion of all study medications
HCV RNA negativity at 24 weeks after completion of all study medications
Secondary Outcomes
- Percentage of Participants Experiencing Serious Adverse Events(72 Weeks from initiation of treatment)
- A Comparison of the Percentage of Participants With Non-detectable HCV-RNA After 24 Weeks of Therapy.(24 weeks)
- Percentage of Participants Experiencing Medically Significant Infections(72 weeks from initiation of treatment)
Investigators
Nizar Zein
Associate Professor of Medicine; Chief, Section of Hepatobiliary Diseases; Medical Director of Liver Transplantation
The Cleveland Clinic
Study Sites (7)
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