Status:
COMPLETED
Pharmacokinetics of LCP-Tacro™ Once Daily and Prograf® Twice A Day in Adult De Novo Liver Transplant Patients
Lead Sponsor:
Veloxis Pharmaceuticals
Collaborating Sponsors:
CTI Clinical Trial and Consulting Services
Aptuit
Conditions:
Liver Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 dr...
Detailed Description
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 tabl...
Eligibility Criteria
Inclusion
- Adult men and women at least 18 years of age who are recipients of a liver transplant from a deceased donor with a Model for End-Stage Liver Disease (MELD) score at the time of transplantation of ≤ 30 who are able to give informed consent for participation
Exclusion
- Recipient of any transplanted organ other than a liver
- Recipients of a liver from a non-heart beating donor
- Recipients of a liver from an ABO incompatible donor
- Recipients of a bone marrow or stem cell transplant
- Patients with a white blood cell count ≤ 2.8 x 109/L unless the absolute neutrophil count (ANC) is \> 1.0 x 109/L
- Patients who fail a drugs of abuse screen in the pre-transplant evaluation
- Patients unable to swallow study medication
- Patients incapable of understanding the purposes and risks of the study, who cannot give written informed consent, or who are unwilling to comply with the study protocol
- Pregnant or nursing women (women of childbearing potential must have a negative serum pregnancy test within seven days prior to receiving study medication)
- Patients with reproductive potential who are unwilling/unable to use a double barrier method of contraception throughout the duration of the study
- Patients who were treated with any other investigational agent in the 30 days prior to enrollment
- Patients seropositive for human immunodeficiency virus (HIV)
- Patients with a current malignancy or a history of malignancy (within the past 5 years), except basal or non-metastatic squamous cell carcinoma of the skin that has been treated successfully, or hepatocellular carcinoma (HCC) that meet the Milan Criteria for liver transplantation
- Patients with uncontrolled concomitant infection, a systemic infection requiring treatment, or any other unstable medical condition that could interfere with the study objectives
- Patients with severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus
- Patients with a known hypersensitivity to tacrolimus
- Patients with any form of current substance abuse, psychiatric disorder or a condition that, in the opinion of the Investigator, may invalidate communication with the Investigator
- Randomization to one of two treatment groups will be done post transplantation provided that the patient fulfills the following additional criteria:
- Patient is able to receive their first dose of randomized study drug orally within 72 hours after the transplant surgery (graft reperfusion)
- Patient was NOT given intravenous tacrolimus prior to their first oral dose of study medication
- Recipient of a liver with a cold ischemia time of ≤ 10 hours
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00772148
Start Date
October 1 2008
End Date
May 1 2010
Last Update
June 25 2015
Active Locations (1)
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1
LifeLink Healthcare Institute
Tampa, Florida, United States, 33606