Safety and Efficacy of Oral Miltefosine in Patients With Post Kala Azar Dermal Leishmaniasis (PKDL) (NCT01635777) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of Oral Miltefosine in Patients With Post Kala Azar Dermal Leishmaniasis (PKDL)
India37 participantsStarted 2007-07
Plain-language summary
Miltefosine efficacy will be \>85%
Who can participate
Age range12 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 12 years or older
* nodules and papules consistent with post kala-azar dermal leishmaniasis
* parasitological confirmation of Leishmania infection
Exclusion Criteria:
* platelet count \<100x 109/l,
* leukocyte count \<2.5 x 109/l ,
* hemoglobin \< 8.0 g/100 ml ,
* liver function tests \>3 times upper limit of normal range,
* bilirubin \>2 times upper limit of normal range,
* serum creatinine or blood urea nitrogen \>1.5 times upper limit of normal range);
* any non-compensated or uncontrolled condition,
* lactation, pregnancy, or likelihood of inadequate contraception in females of childbearing potential for the treatment period plus 2 months thereafter;
* treatment with any anti-leishmanial drug within the previous 12 weeks.