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

Primary Purpose

Hepatitis C, Liver Transplantation

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tacrolimus
steroids, monoclonal anti-IL2R antibody
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis C focused on measuring Tacrolimus, Liver Transplantation, Immunosuppression, Adult, Treatment Outcome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Viral load of HCV at 12 months post transplantation

Secondary Outcome Measures

Biopsy-proven acute rejection
Acute rejection
Patient and graft survival
Incidence of adverse events

Full Information

First Posted
February 22, 2006
Last Updated
April 9, 2013
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00295607
Brief Title
Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in Hepatitis C Virus (HCV) Positive Liver Transplant Patients
Acronym
CHASE
Official Title
Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in HCV Positive in Liver Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Liver Transplantation
Keywords
Tacrolimus, Liver Transplantation, Immunosuppression, Adult, Treatment Outcome

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Other Intervention Name(s)
Prograf, FK506
Intervention Description
immunosuppression
Intervention Type
Drug
Intervention Name(s)
steroids, monoclonal anti-IL2R antibody
Intervention Description
immunosuppression
Primary Outcome Measure Information:
Title
Viral load of HCV at 12 months post transplantation
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Biopsy-proven acute rejection
Time Frame
12 months
Title
Acute rejection
Time Frame
12 months
Title
Patient and graft survival
Time Frame
12 months
Title
Incidence of adverse events
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Physician
Organizational Affiliation
Astellas Pharma Europe B.V.
Official's Role
Study Director
Facility Information:
City
Praha
ZIP/Postal Code
140 21
Country
Czech Republic
City
Besancon
ZIP/Postal Code
25030
Country
France
City
Lyon
ZIP/Postal Code
69317
Country
France
City
Nice
ZIP/Postal Code
06202
Country
France
City
Villejuif
ZIP/Postal Code
94804
Country
France
City
Berlin
ZIP/Postal Code
13353
Country
Germany
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
City
Mainz
ZIP/Postal Code
55131
Country
Germany
City
Bologna
Country
Italy
City
Genova
ZIP/Postal Code
16132
Country
Italy
City
Modena
ZIP/Postal Code
41100
Country
Italy
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
City
Madrid
ZIP/Postal Code
28035
Country
Spain
City
Santiago
ZIP/Postal Code
15706
Country
Spain
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.accessdata.fda.gov/scripts/cder/drugsatfda
Description
Link to FDA Website
URL
http://www.clinicaltrials.jp/user/ctrDetail_e.jsp?resultId=578
Description
Link to Results on JAPIC

Learn more about this trial

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

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