Clinical Trial: Miltefosine to Treat Mucocutaneous Leishmaniasis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Treatment of Mucocutaneous Leishmaniasis With Miltefosine
Brief Summary:
The purpose of this Treatment IND is to make miltefosine available for mucocutaneous leishmaniasis patients presenting in the United States.
If entrance criteria are met, subjects with mucosal or cutaneous leishmaniasis will receive miltefosine at a targeted dose of 2.5 mg/kg/day for 28 days. During treatment at weeks 1, 2, and 4, the patient will return to the treatment facility to be assessed for adverse events. Blood for transaminase and creatinine values will be drawn at the midpoint and at the end of therapy.
Patients will return to the treatment facility to be examined clinically at 6 wks (ie, 2 wks after the end of therapy), 3 months (2 months after therapy), and 7 months (6 months after treatment) for ML and CL patients, and also at 13 months (12 months after treatment) for ML patients.
Detailed Summary:
Sponsor: Knight Therapeutics (USA) Inc
Current Primary Outcome: cure rate at the end of follow up [ Time Frame: 6 months (CL) and 12 months (ML) post therapy ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- symptomatic adverse effects: gastrointestinal [ Time Frame: days 1-28 of therapy ]
- laboratory adverse effects: creatinine or LFT elevation [ Time Frame: days 1-28 of therapy ]
Original Secondary Outcome: Same as current
Information By: Knight Therapeutics (USA) Inc
Dates:
Date Received: January 12, 2010
Date Started: May 2010
Date Completion:
Last Updated: March 24, 2015
Last Verified: January 2011
