Miltefosine to Treat Mucocutaneous Leishmaniasis
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Mucocutaneous Leishmaniasis With Miltefosine|
- cure rate at the end of follow up [ Time Frame: 6 months (CL) and 12 months (ML) post therapy ] [ Designated as safety issue: No ]
- symptomatic adverse effects: gastrointestinal [ Time Frame: days 1-28 of therapy ] [ Designated as safety issue: Yes ]
- laboratory adverse effects: creatinine or LFT elevation [ Time Frame: days 1-28 of therapy ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2010|
|Study Completion Date:||March 2015|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01050907
|United States, Maryland|
|for this treatment IND, each Physician will enter patients at his/her own facility. Below data is for Protocol central contact|
|Bethesda, Maryland, United States, 20852|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Jonathan Berman, MD||Fast Track Drugs and Biologics LLC|