Infliximab Treatment Along With Pegylated Interferon and Ribavirin in the Treatment of Hepatitis C
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Infliximab; Placebo
Intervention description: Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46; Placebo
Intervention MeSH terms: Infliximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 146.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis; HCV; Hepatitis C

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
    

Eligibility criteria:

        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 ≤1.6.

          -  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