Miltefosine to Treat Mucocutaneous Leishmaniasis
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|ClinicalTrials.gov Identifier: NCT01050907|
Recruitment Status : Completed
First Posted : January 18, 2010
Last Update Posted : March 25, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Mucosal Leishmaniasis Cutaneous Leishmaniasis||Drug: miltefosine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Mucocutaneous Leishmaniasis With Miltefosine|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||March 2015|
2.5 mg/kg/day for 28 days
- cure rate at the end of follow up [ Time Frame: 6 months (CL) and 12 months (ML) post therapy ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|