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

April 9, 2013 updated by: Astellas Pharma Inc

Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in HCV Positive in Liver Transplantation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

138

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Viral load of HCV at 12 months post transplantation
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: 12 months
12 months
Biopsy-proven acute rejection
Time Frame: 12 months
12 months
Acute rejection
Time Frame: 12 months
12 months
Patient and graft survival
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Investigators

  • Study Director: Medical Physician, Astellas Pharma Europe B.V.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

February 22, 2006

First Submitted That Met QC Criteria

February 22, 2006

First Posted (Estimate)

February 24, 2006

Study Record Updates

Last Update Posted (Estimate)

April 11, 2013

Last Update Submitted That Met QC Criteria

April 9, 2013

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FG-506-01-28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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