Benefit of Immunoprophylaxis on Fibrosis to Reduce Viral Load After Liver Transplantation
BEFIRTH
Evaluation of the Benefit of Antithymocyte Induction Therapy on Hepatic Fibrosis in de Novo Hepatitis C Virus Liver Transplant Patients.
1 other identifier
interventional
100
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2005
Longer than P75 for phase_4
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 1, 2007
CompletedFirst Posted
Study publicly available on registry
October 2, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedFebruary 3, 2011
February 1, 2011
4.7 years
October 1, 2007
February 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint will be degree of fibrosis = Ishak's histological score of hepatic biopsy at 1 year
1 year
Secondary Outcomes (2)
• Ishak's degree of activity
1 year
Ishak's degree of fibrosis
2 years
Study Arms (3)
A
ACTIVE COMPARATORtacrolimus + steroids
B
EXPERIMENTALATG+ tacrolimus without steroids in maintenance therapy
C
EXPERIMENTALATG+ Mycophenolate Mofetil + tacrolimus a reduced dosage without steroids in maintenance therapy
Interventions
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
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)
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Hopital Pellegrin Tripode
Bordeaux, 33076, France
La CONCEPTION hospital
Marseille, 13385, France
Hopital Saint-Eloi
Montpellier, 34295, France
Hopital de L'Archet
Nice, 06200, France
Hôpital Cochin
Paris, 75000, France
Hôpital Pontchaillou
Rennes, 35, France
University Hospital
Toulouse, 31500, France
Hopital Paul Brousse
Villejuif, 94804, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rostaing Lionel, PhD
University Hospital, Toulouse
- PRINCIPAL INVESTIGATOR
Calmus Yvon, PhD
UHCochin, Paris
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 1, 2007
First Posted
October 2, 2007
Study Start
May 1, 2005
Primary Completion
January 1, 2010
Study Completion
January 1, 2011
Last Updated
February 3, 2011
Record last verified: 2011-02