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

Hepatitis C Clinical Trial

— PARTNER  

Official title:

Infliximab (Remicade®) as an Adjunct to Pegylated- Interferon α-2b and Ribavirin in the Treatment of Hepatitis C Virus Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00512278
• Other study ID #: PARTNER
• Status: Completed
• Phase: Phase 2
• First received: August 3, 2007
• Last updated: November 14, 2012
• Start date: July 2007
• Est. completion date: May 2012

Study information

• Verified date: November 2012
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 (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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 a-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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• Infliximab
Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Case Medical Center	Cleveland	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	The Liver Institute at Methodist Dallas	Dallas	Texas
United States	Cedars-Sinai Medical Center, Center for Liver Disease and Transplantation	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	Advanced Medical Research Center	Port Orange	Florida
United States	Brooke Army Medical Center	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Nizar Zein	Centocor, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare proportion of chronic hepatitis C subjects (treatment naive,Genotype 1) who achieve SVR at week 72, after 48 weeks of treatment.		Study start to study end	No
Secondary	Compare proportion with non-detectable HCV-RNA after 24 and 48 wks of therapy. Compare the proportion with normal ALT after 12 , 24, 48 wks and after 24 wks of tx-free FU after 48 wks of tx.		Start of study to end of study	No