Liver Failure Clinical Trial
Official title:
A Phase 2, Open-Label, Multi-Center, Randomized Trial to Demonstrate the Pharmacokinetics of LCP-Tacro™ Tablets Once Daily and Prograf® Capsules Twice Daily in Adult De Novo Liver Transplant Patients
The purpose of this study is to demonstrate the pharmacokinetics (PK, measuring the amount
of medication in blood samples) and safety of a new medicine, LCP-Tacro™ tablets, and
Prograf® capsules, a drug commonly taken by transplant recipients to prevent the body from
rejecting a transplanted kidney and liver. LCP-Tacro is a tablet containing the same active
ingredient (tacrolimus) that is in Prograf capsules, but the tablet has been designed to
release tacrolimus over an extended period so that it only has to be taken once daily.
LCP-Tacro is an investigational drug.
This study will evaluate the levels of tacrolimus in the blood in the first two weeks after
a liver transplant in patients randomly assigned (by chance, like flipping a coin) to take
either LCP-Tacro™ tablets (tacrolimus) once daily or Prograf® capsules twice daily. In
addition, patients will remain on study drug for 360 days in order to evaluate the relative
safety of LCP-Tacro™ tablets compared to Prograf over a longer period of time.
This was a randomized, parallel-group, open-label, multicenter study in adult de novo liver
transplant patients to demonstrate the pharmacokinetics and safety of once-daily treatment
of LCP-Tacro tablets and twice-daily Prograf capsules in the first 2 weeks after live
transplantation. The study also compared the efficacy and safety of LCP-Tacro and Prograf
over an additional 50 weeks after liver transplantation. Eligible patients were randomized
(1:1 ratio) within 72 hours after transplantation (graft reperfusion) to receive either: 1)
LCP-Tacr tablets orally once daily (QD) in the morning, with an interval of 24 +/- 1 hours
between dosed, starting at 0.07 to 0.11 mg/kg (the starting daily dose for African-American
patients was 0.09 to 0.13 mg/kg), or 2) Prograf capsules in 2 equally divided morning and
evening doses, starting at 0.10 to 0.15 mg. Subsequent doses of study medications were to be
adjusted by the investigator according to local practice to maintain a target whole blood
tacrolimus trough level of 5 to 20 ng/mL thought Day 14. Twenty-four-hour pharmacokinetic
assessments were performed on Days 1, 7 and 14; additionally whole blood tacrolimus trough
levels for statistical analysis were measured on Days 2, 3, 4, 7, 10, 12, 12, 42, 90, 120,
180, 270, and 360. Physicians could also perform tacrolimus trough levels at other times at
their discretion. On Day 360, the patients were placed on maintenance immunosuppressive
regimen determined by their treating physician. Following completion of the third and final
pharmacokinetic assessment on Day 14, patients entered the maintenance phase (Days 15 to
360) of study and remained on their assigned study medication until Day 360. Visits for
safety assessments and tacrolimus trough levels during the maintenance phase were on Days
42, 90, 120, 180, 270 and 360.
Immunosuppressive therapy after the conclusion of the study was to be administered at the
discretion of the patient's population.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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