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

Hepatitis C Clinical Trial

— CHASE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00295607
• Other study ID #: FG-506-01-28
• Status: Completed
• Phase: Phase 2
• First received: February 22, 2006
• Last updated: April 9, 2013
• Start date: June 2005
• Est. completion date: June 2008

Study information

• Verified date: September 2011
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Liver Transplantation

Intervention

Drug:
• Tacrolimus
immunosuppression
• steroids, monoclonal anti-IL2R antibody
immunosuppression

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Czech Republic,  France,  Germany,  Italy,  Poland,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral load of HCV at 12 months post transplantation		12 months	No
Secondary	Biopsy-proven acute rejection		12 months	No
Secondary	Acute rejection		12 months	No
Secondary	Patient and graft survival		12 months	No
Secondary	Incidence of adverse events		12 months	No

External Links

•   Link to FDA Website
•   Link to Results on JAPIC