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Infliximab Treatment Along With Pegylated Interferon and Ribavirin in the Treatment of Hepatitis C (PARTNER)
This study is currently recruiting participants.
Verified by The Cleveland Clinic, December 2008
Sponsored by: The Cleveland Clinic
Information provided by: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00512278
  Purpose

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

Condition Intervention Phase
Hepatitis C
Drug: Infliximab
Other: Placebo
Phase II

MedlinePlus related topics: Hepatitis Hepatitis C
Drug Information available for: Ribavirin Interferons Infliximab BaseLine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
Official Title: Infliximab (Remicade®) as an Adjunct to Pegylated- Interferon α-2b and Ribavirin in the Treatment of Hepatitis C Virus Infection

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Compare proportion of chronic hepatitis C subjects (treatment naive,Genotype 1) who achieve SVR at week 72, after 48 weeks of treatment. [ Time Frame: Study start to study end ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Start of study to end of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: July 2007
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Infliximab
Drug: Infliximab
Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46
B: Placebo Comparator
Placebo
Other: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00512278

Contacts
Contact: Liz Fabry-Ribaudo, RN, MSN 216-445-4354 fabryl@ccf.org

Locations
United States, California
Cedars-Sinai Medical Center, Center for Liver Disease and Transplantation Recruiting
Los Angeles, California, United States, 90048
Contact: Martin Briseno, RN     310-721-6556     martin.briseno@cshs.org    
Principal Investigator: Fred Poordad            
United States, Florida
Advanced Medical Research Center Recruiting
Port Orange, Florida, United States, 32127
Contact: Svetlana Klycheva, MD, Ph.D     386-481-6671     sklycheva@fhcp.com    
Principal Investigator: Ammar Hemaidan            
United States, Missouri
Kansa City Gastroenterology & Hepatology Practice Recruiting
Kansas City, Missouri, United States, 64131
Contact: Laurie Lynn     816-285-0103     laurie@digestivenet.com    
Principal Investigator: Bradley Freilich            
United States, Ohio
Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Laura Veri     216-844-7214     laura.veri@Uhhospitals.org    
Principal Investigator: Anthony Post            
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Louise Kincade     216-444-3076     kincadl@ccf.org    
Principal Investigator: Nizar Zein, MD            
United States, Texas
The Liver Institute at Methodist Dallas Recruiting
Dallas, Texas, United States, 75203
Contact: Deborah Romines     214-947-4419     deborahromines@mhd.com    
Principal Investigator: Reem Ghalib, MD            
Brooke Army Medical Center Recruiting
San Antonio, Texas, United States, 78234
Contact: Karol Barstow     210-916-4811     karol.barstow@amedd.army.mil    
Principal Investigator: Stephen Harrison            
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Nizar N Zein, MD Cleveland Clinic
  More Information

Responsible Party: Cleveland Clinic ( Nizar Zein MD / Sponsor Principal Investigator )
Study ID Numbers: PARTNER
Study First Received: August 3, 2007
Last Updated: December 9, 2008
ClinicalTrials.gov Identifier: NCT00512278  
Health Authority: United States: Food and Drug Administration

Keywords provided by The Cleveland Clinic:
Hepatitis
HCV
Hepatitis C

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Infliximab
Interferons
Ribavirin
Hepatitis, Viral, Human
Hepatitis C

Additional relevant MeSH terms:
Anti-Inflammatory Agents
RNA Virus Infections
Flaviviridae Infections
Therapeutic Uses
Gastrointestinal Agents
Antirheumatic Agents
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009