Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in Hepatitis C Virus (HCV) Positive Liver Transplant Patients (CHASE)
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00295607
First received: February 22, 2006
Last updated: April 9, 2013
Last verified: September 2011
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Purpose
This is an exploratory study to evaluate the impact of eliminating steroid administration upon viral HCV load at 12 months measured by quantitative serum HCV-RNA determination in patients transplanted for HCV cirrhosis.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C Liver Transplantation |
Drug: Tacrolimus Drug: steroids, monoclonal anti-IL2R antibody |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in HCV Positive in Liver Transplantation |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Viral load of HCV at 12 months post transplantation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Biopsy-proven acute rejection [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Acute rejection [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Patient and graft survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 138 |
| Study Start Date: | June 2005 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: Tacrolimus
immunosuppression
Other Name: Prograf, FK506
Drug: steroids, monoclonal anti-IL2R antibody
immunosuppression
|
| Experimental: 2 |
Drug: Tacrolimus
immunosuppression
Other Name: Prograf, FK506
|
Detailed Description:
A comparison will be made between two regimens which both include tacrolimus, one utilizing standard steroid administration and the second with daclizumab (MAB) avoiding steroids for both prophylactic administration and anti-rejection treatment.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients 18 to 65 years of age who will undergo primary orthotopic liver or split liver allograft transplantation for HCV-cirrhosis are eligible for the study.
- Patients receiving a cadaveric liver transplant with compatible ABO blood type can be included.
Exclusion Criteria:
- Recipient of multi-organ transplant
- Recipient of an auxiliary graft
- Patient is receiving ABO incompatible graft
- Patients requiring immunosuppressive treatment
- Patients requiring ongoing corticosteroid therapy.
- Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
- Patient or donor is known to be HIV positive.
- Patient is allergic or intolerant to study medication
- Patient is pregnant or breast-feeding.
- Patient has been previously enrolled in this study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00295607
Locations
| Czech Republic | |
| Praha, Czech Republic, 140 21 | |
| France | |
| Besancon, France, 25030 | |
| Lyon, France, 69317 | |
| Nice, France, 06202 | |
| Villejuif, France, 94804 | |
| Germany | |
| Berlin, Germany, 13353 | |
| Hamburg, Germany, 20251 | |
| Mainz, Germany, 55131 | |
| Italy | |
| Bologna, Italy | |
| Genova, Italy, 16132 | |
| Modena, Italy, 41100 | |
| Poland | |
| Warszawa, Poland, 02-097 | |
| Spain | |
| Barakaldo, Spain, 48903 | |
| Madrid, Spain, 28035 | |
| Santiago, Spain, 15706 | |
| Sweden | |
| Goteborg, Sweden, 413 45 | |
| United Kingdom | |
| London, United Kingdom, SE5 9RS | |
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Director: | Medical Physician | Astellas Pharma Europe |
More Information
Additional Information:
No publications provided
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00295607 History of Changes |
| Other Study ID Numbers: | FG-506-01-28 |
| Study First Received: | February 22, 2006 |
| Last Updated: | April 9, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Astellas Pharma Inc:
|
Tacrolimus Liver Transplantation Immunosuppression Adult Treatment Outcome |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Antibodies Immunoglobulins |
Tacrolimus Interleukin-2 Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Immunosuppressive Agents |
ClinicalTrials.gov processed this record on May 19, 2013