Infliximab Treatment Along With Pegylated Interferon and Ribavirin in the Treatment of Hepatitis C (PARTNER)
This study has been completed.
Information provided by (Responsible Party):
Nizar Zein, Cleveland Clinic Foundation
First received: August 3, 2007
Last updated: November 14, 2012
Last verified: November 2012
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
||Infliximab (Remicade®) as an Adjunct to Pegylated- Interferon α-2b and Ribavirin in the Treatment of Hepatitis C Virus Infection
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2012 (Final data collection date for primary outcome measure)
Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab
Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46
Placebo Comparator: B
Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00512278
|Cedars-Sinai Medical Center, Center for Liver Disease and Transplantation
|Los Angeles, California, United States, 90048 |
|Advanced Medical Research Center
|Port Orange, Florida, United States, 32127 |
|University of Louisville
|Louisville, Kentucky, United States, 440292 |
|Case Medical Center
|Cleveland, Ohio, United States, 44106 |
|Cleveland, Ohio, United States, 44195 |
|The Liver Institute at Methodist Dallas
|Dallas, Texas, United States, 75203 |
|Brooke Army Medical Center
|San Antonio, Texas, United States, 78234 |
||Nizar N Zein, MD
||The Cleveland Clinic
||Nizar Zein, Associate Professor of Medicine; Chief, Section of Hepatobiliary Diseases; Medical Director of Liver Transplantation, Cleveland Clinic Foundation
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 3, 2007
||November 14, 2012
||United States: Food and Drug Administration
Keywords provided by The Cleveland Clinic:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 06, 2016
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action