Infliximab Treatment Along With Pegylated Interferon and Ribavirin in the Treatment of Hepatitis C (PARTNER)

Nizar Zein

Status and phase

Completed

Phase 2

Conditions

Hepatitis C

Treatments

Drug: Placebo

Drug: Infliximab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00512278

PARTNER

Details and patient eligibility

About

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

Full 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

Enrollment

146 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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