Safety and Efficacy of Oral Miltefosine in Patients With Post Kala Azar Dermal Leishmaniasis (PKDL)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01635777 |
Recruitment Status
:
Completed
First Posted
: July 10, 2012
Last Update Posted
: July 10, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
PKDL | Drug: Miltefosine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 37 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | July 2007 |
Actual Primary Completion Date : | October 2009 |
Actual Study Completion Date : | December 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: 12 weeks
miltefosine 12 weeks
|
Drug: Miltefosine
2.5 mg/kg/day for 12 weeks
|
Experimental: 8 weeks
miltefosine 8 weeks
|
Drug: Miltefosine
2.5 mg/kg/day for 8 weeks
|
- Cure rate [ Time Frame: 12 months after end of treatment ]
- adverse events [ Time Frame: during therapy: the 8 weeks of therapy for the 8 week treatment group and 12 weeks of therapy for the 12 week treatment group ]gastrointestinal events: vomiting and diarrhea

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years to 65 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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): NCT01635777
India | |
Institute of Medical Sciences, Banaras Hindu University, | |
Varanasi, India, 221005 |
Responsible Party: | AB Foundation |
ClinicalTrials.gov Identifier: | NCT01635777 History of Changes |
Other Study ID Numbers: |
Z015 |
First Posted: | July 10, 2012 Key Record Dates |
Last Update Posted: | July 10, 2012 |
Last Verified: | July 2012 |
Keywords provided by AB Foundation:
PKDL miltefosine |
Additional relevant MeSH terms:
Miltefosine Antifungal Agents Anti-Infective Agents |
Antineoplastic Agents Antiprotozoal Agents Antiparasitic Agents |