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

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00295607

Purpose

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	Intervention	Phase
Hepatitis C Liver Transplantation	Drug: Tacrolimus Drug: steroids, monoclonal anti-IL2R antibody	Phase II

MedlinePlus related topics: Hepatitis Hepatitis C Liver Transplantation

Drug Information available for: Tacrolimus Immunoglobulins Globulin, Immune Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in HCV Positive in Liver Transplantation

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Viral load of HCV at 12 months post transplantation [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Biopsy-proven acute rejection [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Acute rejection [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Patient and graft survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	137
Study Start Date:	June 2005
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Tacrolimus immunosuppression Drug: steroids, monoclonal anti-IL2R antibody immunosuppression
2: Experimental	Drug: Tacrolimus immunosuppression

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295607

Locations

Czech Republic

Praha, Czech Republic, 140 21
France

Villejuif, France, 94804

Nice, France, 06202

Lyon, France, 69317

Besancon, France, 25030
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

Madrid, Spain, 28035

Barakaldo, Spain, 48903

Santiago, Spain, 15706
Sweden

Goteborg, Sweden, 413 45
United Kingdom

London, United Kingdom, SE5 9RS

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Medical Physician

Astellas Pharma Europe

More Information

Link to FDA Website This link exits the ClinicalTrials.gov site

Responsible Party:	Astellas Pharma Europe BV ( Disclosure Office Europe )
Study ID Numbers:	FG-506-01-28
Study First Received:	February 22, 2006
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00295607
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Astellas Pharma Inc:

Tacrolimus
Liver Transplantation
Immunosuppression
Adult
Treatment Outcome

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Antibodies
Liver Diseases
Digestive System Diseases

Hepatitis, Viral, Human
Tacrolimus
Hepatitis C
Immunoglobulins

Additional relevant MeSH terms:

RNA Virus Infections
Immunologic Factors
Flaviviridae Infections

Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009