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Trial record 6 of 65 for:    "Viral Infectious Disease" | "Mycophenolic acid"

Benefit of Immunoprophylaxis on Fibrosis to Reduce Viral Load After Liver Transplantation (BEFIRTH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00538265
Recruitment Status : Completed
First Posted : October 2, 2007
Last Update Posted : February 3, 2011
Information provided by:
University Hospital, Toulouse

Brief Summary:
An open-label randomized multicenter clinical study comparing three regimes of immunosuppression : (A) tacrolimus and steroids, (B) antithymocyte induction therapy and full dose of tacrolimus, (C) antithymocyte induction therapy with mycophenolate mofetil and a reduced dose of tacrolimus.

Condition or disease Intervention/treatment Phase
Liver Transplantation Drug: tacrolimus Drug: tacrolimus, ATG Drug: ATG+mycophénolate mofétil+tacrolimus Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Benefit of Antithymocyte Induction Therapy on Hepatic Fibrosis in de Novo Hepatitis C Virus Liver Transplant Patients.
Study Start Date : May 2005
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2011

Arm Intervention/treatment
Active Comparator: A
tacrolimus + steroids
Drug: tacrolimus
Tacrolimus started at 0.50 mg/kg b.i.d. starting at D0, by nasogastric tube and then 1 to 2 hours before meals. The dose of tacrolimus will be adjusted as soon as possible to obtain trough concentrations of the product between 10 and 20 µg/L between D0 and 6 months and then between 8 and 15 µg/L after 6 months
Other Name: PROGRAF

Experimental: B
ATG+ tacrolimus without steroids in maintenance therapy
Drug: tacrolimus, ATG

immunoprophylaxis allowing sparing of steroids in maintenance therapy combining induction therapy with 3 injections of antithymocyte globulins (ATG) (1.5 mg/kg/d at D0, D2 and D4) and tacrolimus at usual dosage.

In this group of patients, the first injection of ATG will be infused over a period of at least 6 hours and will be started as soon as vascular anastomosis has been completed. It will be preceded by an injection of 3 mg/kg/d methylprednisolone. The second injection of ATG at D2, post transplantation will also be infused over 6 hours and will be preceded by an injection of 1 mg/kg methylprednisolone, and then subsequently steroids will be excluded from the treatment. The third and last injection at D4 post transplantation will be administered over a 6-hour period but will not be preceded by steroids.

In this study arm, tacrolimus will be administered as in arm (A)

Other Name: Thymoglobuline

Experimental: C
ATG+ Mycophenolate Mofetil + tacrolimus a reduced dosage without steroids in maintenance therapy
Drug: ATG+mycophénolate mofétil+tacrolimus

immunoprophylaxis allowing sparing of steroids in maintenance therapy combined with mycophenolate mofetil, at an initial dosage of 2 grams a day, and then adjusted to safety and tolerability in such a way so as to maintain PMN ≥ 750/mm3, and platelet counts ≥ 30000/mm3.

In this study arm, the patients will receive the same doses of ATG and steroids (and according to the same methods) as in arm B. Tacrolimus started at 0.05 mg/kg b.i.d. starting at D0 by nasogastric tube and then 1 to 2 hours before meals. In this study arm, the tacrolimus dose will be reduced: targeted trough concentrations will be between 7 and 12 µg/L between D0 and 6 months and then between 3 et 7 µg/L after 6 months.

Other Name: Mycophénolate mofétil = Cellcept

Primary Outcome Measures :
  1. The primary endpoint will be degree of fibrosis = Ishak's histological score of hepatic biopsy at 1 year [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. • Ishak's degree of activity [ Time Frame: 1 year ]
  2. Ishak's degree of fibrosis [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients who received a first liver transplantation,
  • presenting with a qualitative or quantitative PCR positive for hepatitis C virus at time of transplantation, whatever the transaminase activity,
  • Women of childbearing potential with a negative pregnancy test,
  • Male or female patients who agree to use an effective method of contraception,
  • patients who signed a written informed consent form to participate in the study,
  • patients who are compliant and likely to follow the visits specified by the study protocol

Exclusion Criteria:

  • • Preoperative serious renal impairment (serum creatinine levels > 200 µmol/l),

    • repeat transplantation,
    • multiple organ transplantation,
    • transplantation performed with an organ transplant obtained from a living donor or a reduced or shared organ grafts,
    • serious concomitant disorder,
    • positive serology for HBs antigen or HIV positive at time of enrollment,
    • previous history of nonhepatic cancer (except for localized skin cancer),
    • presence of a hepatocellular carcinoma, for which the primary lesion exceeds 5 cm or is complicated by portal thrombosis or metastatic disease,
    • an investigational product or therapy administered less than one month before entry into the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00538265

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Hopital Pellegrin Tripode
Bordeaux, France, 33076
La CONCEPTION hospital
Marseille, France, 13385
Hopital Saint-Eloi
Montpellier, France, 34295
Hopital de L'Archet
Nice, France, 06200
Hôpital Cochin
Paris, France, 75000
Hôpital Pontchaillou
Rennes, France, 35
University Hospital
Toulouse, France, 31500
Hopital Paul Brousse
Villejuif, France, 94804
Sponsors and Collaborators
University Hospital, Toulouse
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Principal Investigator: Rostaing Lionel, PhD University Hospital, Toulouse
Principal Investigator: Calmus Yvon, PhD UHCochin, Paris

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Responsible Party: LLAU ME, University Hospital Toulouse Identifier: NCT00538265     History of Changes
Other Study ID Numbers: 0404003
First Posted: October 2, 2007    Key Record Dates
Last Update Posted: February 3, 2011
Last Verified: February 2011
Keywords provided by University Hospital, Toulouse:
liver transplantation, hepatitis C virus, immunoprophylaxis
Additional relevant MeSH terms:
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Mycophenolic Acid
Pathologic Processes
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents