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

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ClinicalTrials.gov Identifier: NCT00538265
Recruitment Status : Completed
First Posted : October 2, 2007
Last Update Posted : February 3, 2011
Sponsor:
Information provided by:
University Hospital, Toulouse

Tracking Information
First Submitted Date  ICMJE October 1, 2007
First Posted Date  ICMJE October 2, 2007
Last Update Posted Date February 3, 2011
Study Start Date  ICMJE May 2005
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2007)
The primary endpoint will be degree of fibrosis = Ishak's histological score of hepatic biopsy at 1 year [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00538265 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2007)
  • • Ishak's degree of activity [ Time Frame: 1 year ]
  • Ishak's degree of fibrosis [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Benefit of Immunoprophylaxis on Fibrosis to Reduce Viral Load After Liver Transplantation
Official Title  ICMJE Evaluation of the Benefit of Antithymocyte Induction Therapy on Hepatic Fibrosis in de Novo Hepatitis C Virus Liver Transplant Patients.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Liver Transplantation
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: A
    tacrolimus + steroids
    Intervention: Drug: tacrolimus
  • Experimental: B
    ATG+ tacrolimus without steroids in maintenance therapy
    Intervention: Drug: tacrolimus, ATG
  • Experimental: C
    ATG+ Mycophenolate Mofetil + tacrolimus a reduced dosage without steroids in maintenance therapy
    Intervention: Drug: ATG+mycophénolate mofétil+tacrolimus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 1, 2007)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00538265
Other Study ID Numbers  ICMJE 0404003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party LLAU ME, University Hospital Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rostaing Lionel, PhD University Hospital, Toulouse
Principal Investigator: Calmus Yvon, PhD UHCochin, Paris
PRS Account University Hospital, Toulouse
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP