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Sponsored by: |
The Cleveland Clinic |
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Information provided by: | The Cleveland Clinic |
ClinicalTrials.gov Identifier: | NCT00512278 |
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:
Condition | Intervention | Phase |
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Hepatitis C |
Drug: Infliximab Other: Placebo |
Phase II |
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 |
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 |
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A: Experimental
Infliximab
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Drug: Infliximab
Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46
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B: Placebo Comparator
Placebo
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Other: Placebo
Placebo
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Criteria for inclusion in this trial are as follows:
Exclusion Criteria:
Contact: Liz Fabry-Ribaudo, RN, MSN | 216-445-4354 | fabryl@ccf.org |
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 |
Principal Investigator: | Nizar N Zein, MD | Cleveland Clinic |
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 |
Hepatitis HCV Hepatitis C |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Infliximab |
Interferons Ribavirin Hepatitis, Viral, Human Hepatitis C |
Anti-Inflammatory Agents RNA Virus Infections Flaviviridae Infections Therapeutic Uses |
Gastrointestinal Agents Antirheumatic Agents Dermatologic Agents Pharmacologic Actions |