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A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Liver Transplant Patients.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00545402
First received: October 16, 2007
Last updated: October 10, 2012
Last verified: October 2012
History of Changes
  Purpose

This 2 arm study will compare the efficacy and safety of two CellCept-containing treatment regimens in de novo liver transplant patients. Patients will be randomized into one of two groups, to receive either CellCept (at a starting dose of 3g/day po, adjusted according to exposure) standard dose tacrolimus and corticosteroids (10-15 mg/kg i.v. on day 0), or fixed dose CellCept 2g/day po, standard dose tacrolimus and corticosteroids (10-15mg/kg i.v. on day 0, then reducing from 20mg to 5mg over 6 months, and discontinuing after 6 months). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Liver Transplantation
 Drug: mycophenolate mofetil [CellCept]
Drug: Tacrolimus
Drug: Corticosteroids
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open Label Study Comparing the Effect of CellCept With Therapeutic Drug Monitoring, Tacrolimus and a Corticosteroid-sparing Regimen Versus Fixed Dose CellCept, Tacrolimus and Corticosteroids Maintained up to 6 Months, on Acute Rejection and Safety in Liver Transplant Patients.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Incidence of biopsy-proven and treated acute rejection [ Time Frame: Up to month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient and graft survival; histological evaluation of grafts. [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Cardiovascular outcomes and renal function [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 187
Study Start Date: November 2007
Study Completion Date: February 2012
Arms Assigned Interventions
Experimental: 1 Drug: mycophenolate mofetil [CellCept]
3g/day po (starting dose)
Drug: Tacrolimus
Standard, as prescribed
Drug: Corticosteroids
10-15mg/kg iv
Experimental: 2 Drug: Tacrolimus
Standard, as prescribed
Drug: mycophenolate mofetil [CellCept]
2g/day po (fixed dose)
Drug: Corticosteroids
10-15mg iv reducing to 5mg over 6 months, then discontinuing

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • recipient of a first orthotopic liver transplant.

Exclusion Criteria:

  • history of organ transplants;
  • patient receiving a multi-organ transplant;
  • calculated creatinine clearance <=30mL/min before transplant;
  • leukocyte count < 2000/mm3 at randomization;
  • history of cancer within past 5 years, except for successfully treated basal cell or squamous cell cancer, or in situ cervical cancer;
  • pregnant or breast-feeding females, or females of childbearing age not using effective contraception.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545402

Locations
France
Besancon, France, 25030
Bordeaux, France, 33076
Caen, France, 14033
Clichy, France, 92118
Creteil, France, 94010
Grenoble, France, 38043
Lille, France, 59037
Lyon, France, 69317
Lyon, France, 69003
Marseille, France, 13385
Montpellier, France, 34295
Nice, France, 06202
Paris, France, 75014
Rennes, France, 35033
Toulouse, France, 31054
Villejuif, France, 94804
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00545402     History of Changes
Other Study ID Numbers: ML21273
Study First Received: October 16, 2007
Last Updated: October 10, 2012
Health Authority: France:Agence francaise de securite sanitaire des produits de sante (AFSSAPS)

Additional relevant MeSH terms:
Mycophenolate mofetil
Tacrolimus
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 17, 2012