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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00295607

Collaborator

(none)

138

Enrollment

Locations

Arms

Duration (Months)

8.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Jun 1, 2005

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1	Drug: Tacrolimus immunosuppression Other Names: Prograf, FK506 Drug: steroids, monoclonal anti-IL2R antibody immunosuppression
Experimental: 2	Drug: Tacrolimus immunosuppression Other Names: Prograf, FK506

Arm

Intervention/Treatment

Active Comparator: 1

Drug: Tacrolimus

immunosuppression

Other Names:

Prograf, FK506

Drug: steroids, monoclonal anti-IL2R antibody

immunosuppression

Experimental: 2

Drug: Tacrolimus

immunosuppression

Other Names:

Prograf, FK506

Outcome Measures

Primary Outcome Measures

Viral load of HCV at 12 months post transplantation [12 months]

Secondary Outcome Measures

Biopsy-proven acute rejection [12 months]
Acute rejection [12 months]
Patient and graft survival [12 months]
Incidence of adverse events [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	City	Country	Postal Code
1	Praha	Czech Republic	140 21
2	Besancon	France	25030
3	Lyon	France	69317
4	Nice	France	06202
5	Villejuif	France	94804
6	Berlin	Germany	13353
7	Hamburg	Germany	20251
8	Mainz	Germany	55131
9	Bologna	Italy
10	Genova	Italy	16132
11	Modena	Italy	41100
12	Warszawa	Poland	02-097
13	Barakaldo	Spain	48903
14	Madrid	Spain	28035
15	Santiago	Spain	15706
16	Goteborg	Sweden	413 45
17	London	United Kingdom	SE5 9RS