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Safety and Efficacy of Oral Miltefosine in Patients With Post Kala Azar Dermal Leishmaniasis (PKDL)

This study has been completed.
World Health Organization
Information provided by (Responsible Party):
AB Foundation Identifier:
First received: July 3, 2012
Last updated: July 9, 2012
Last verified: July 2012
Miltefosine efficacy will be >85%

Condition Intervention Phase
PKDL Drug: Miltefosine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by AB Foundation:

Primary Outcome Measures:
  • Cure rate [ Time Frame: 12 months after end of treatment ]

Secondary Outcome Measures:
  • 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

Enrollment: 37
Study Start Date: July 2007
Study Completion Date: December 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01635777

Institute of Medical Sciences, Banaras Hindu University,
Varanasi, India, 221005
Sponsors and Collaborators
AB Foundation
World Health Organization
  More Information

Responsible Party: AB Foundation Identifier: NCT01635777     History of Changes
Other Study ID Numbers: Z015
Study First Received: July 3, 2012
Last Updated: July 9, 2012

Keywords provided by AB Foundation:

Additional relevant MeSH terms:
Antifungal Agents
Anti-Infective Agents
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents processed this record on August 18, 2017