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
Verified date | June 2015 |
Source | Veloxis Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 58 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | LifeLink Healthcare Institute | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Veloxis Pharmaceuticals | Aptuit Inc., CTI Clinical Trial and Consulting Services |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetics (Cmax and Cmin) of LCP-Tacro™ Compared to Prograf Early After Transplantations (Within the First 14 Days) in Adult de Novo Liver Transplant Recipients. | The pharmacokinetic parameters (Cmax and Cmin) were evaluated during the first 14 days after liver transplant (on days 1, 7 and 14). The results for Day 14 is listed below as the primary outcome parameter for this study. | 14 days | No |
Primary | Pharmacokinetics (AUC0-24) of LCP-Tacro™ Compared to Prograf Early After Transplantations (Within the First 14 Days) in Adult de Novo Liver Transplant Recipients. | The pharmacokinetic parameter (AUC, 0 to 24 hours post dose) was evaluated during the first 14 days after liver transplant (on days 1, 7 and 14). The results for Day 14 is listed below as the primary outcome parameter for this study. | 14 days | No |
Primary | Percentage of Patients in Each Treatment Group Achieving Sufficient Tacrolimus Whole Blood Trough Levels (5 to 20 ng/mL) During the First 14 Days Post-transplantation. | Percentage of patients with trough levels within the therapeutic range of 5 to 20 ng/mL was assessed during the initial 14 days (on days 1, 7 and 14) after liver transplant and compared between the two treatment groups. | 1 day | No |
Primary | Percentage of Patients in Each Treatment Group Achieving Sufficient Tacrolimus Whole Blood Trough Levels (5 to 20 ng/mL) During the First 14 Days Post-transplantation. | Percentage of patients with trough levels within the therapeutic range of 5 to 20 ng/mL was assessed during the initial 14 days (on days 1, 7 and 14) after liver transplant and compared between the two treatment groups. | 7 days | No |
Primary | Percentage of Patients in Each Treatment Group Achieving Sufficient Tacrolimus Whole Blood Trough Levels (5 to 20 ng/mL) During the First 14 Days Post-transplantation. | Percentage of patients with trough levels within the therapeutic range of 5 to 20 ng/mL was assessed during the initial 14 days (on days 1, 7 and 14) after liver transplant and compared between the two treatment groups. | 14 days | No |
Secondary | Number of Participants Who Died Within the 360 Days. | Number of patients who died was compared between the two groups during the study. | 360 days | Yes |
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