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:
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
  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 April 16, 2014