Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in Hepatitis C Virus (HCV) Positive Liver Transplant Patients (CHASE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00295607
Recruitment Status : Completed
First Posted : February 24, 2006
Last Update Posted : April 11, 2013
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis C Liver Transplantation Drug: Tacrolimus Drug: steroids, monoclonal anti-IL2R antibody Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2005
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1 Drug: Tacrolimus
Other Name: Prograf, FK506

Drug: steroids, monoclonal anti-IL2R antibody

Experimental: 2 Drug: Tacrolimus
Other Name: Prograf, FK506

Primary Outcome Measures :
  1. Viral load of HCV at 12 months post transplantation [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Biopsy-proven acute rejection [ Time Frame: 12 months ]
  2. Acute rejection [ Time Frame: 12 months ]
  3. Patient and graft survival [ Time Frame: 12 months ]
  4. Incidence of adverse events [ Time Frame: 12 months ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00295607

Czech Republic
Praha, Czech Republic, 140 21
Besancon, France, 25030
Lyon, France, 69317
Nice, France, 06202
Villejuif, France, 94804
Berlin, Germany, 13353
Hamburg, Germany, 20251
Mainz, Germany, 55131
Bologna, Italy
Genova, Italy, 16132
Modena, Italy, 41100
Warszawa, Poland, 02-097
Barakaldo, Spain, 48903
Madrid, Spain, 28035
Santiago, Spain, 15706
Goteborg, Sweden, 413 45
United Kingdom
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Medical Physician Astellas Pharma Europe B.V.

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00295607     History of Changes
Other Study ID Numbers: FG-506-01-28
First Posted: February 24, 2006    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: September 2011

Keywords provided by Astellas Pharma Inc:
Liver Transplantation
Treatment Outcome

Additional relevant MeSH terms:
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action