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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00512278
Recruitment Status : Completed
First Posted : August 7, 2007
Results First Posted : September 13, 2017
Last Update Posted : September 13, 2017
Centocor, Inc.
Information provided by (Responsible Party):
Nizar Zein, The Cleveland Clinic

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

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Infliximab Drug: Placebo Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Infliximab (Remicade®) as an Adjunct to Pegylated- Interferon α-2b and Ribavirin in the Treatment of Hepatitis C Virus Infection
Study Start Date : July 2007
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Arm Intervention/treatment
Experimental: Infliximab
Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab
Drug: Infliximab
Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46
Other Name: Remicade

Placebo Comparator: Placebo
Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV
Drug: Placebo

Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. A Comparison of the Percentage of Participants With Non-detectable HCV-RNA After 24 Weeks of Therapy. [ Time Frame: 24 weeks ]
    A comparison of the proportion of the subject population with non-detectable HCV-RNA after 24 wks of therapy.

  2. Percentage of Participants Experiencing Serious Adverse Events [ Time Frame: 72 Weeks from initiation of treatment ]
    The severity of adverse events was graded according to modified World Health Organization grades as mild, moderate, severe, or life-threatening

  3. Percentage of Participants Experiencing Medically Significant Infections [ Time Frame: 72 weeks from initiation of treatment ]
    Medically significant infection was defined as an infection requiring the use of intravenous antibiotics or hospitalization.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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 ≤1.6.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00512278

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United States, California
Cedars-Sinai Medical Center, Center for Liver Disease and Transplantation
Los Angeles, California, United States, 90048
United States, Florida
Advanced Medical Research Center
Port Orange, Florida, United States, 32127
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 440292
United States, Ohio
Case Medical Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Texas
The Liver Institute at Methodist Dallas
Dallas, Texas, United States, 75203
Brooke Army Medical Center
San Antonio, Texas, United States, 78234
Sponsors and Collaborators
Nizar Zein
Centocor, Inc.
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Principal Investigator: Nizar N Zein, MD The Cleveland Clinic
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Responsible Party: Nizar Zein, Associate Professor of Medicine; Chief, Section of Hepatobiliary Diseases; Medical Director of Liver Transplantation, The Cleveland Clinic Identifier: NCT00512278    
Other Study ID Numbers: PARTNER
First Posted: August 7, 2007    Key Record Dates
Results First Posted: September 13, 2017
Last Update Posted: September 13, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nizar Zein, The Cleveland Clinic:
Hepatitis C
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents