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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01635777
First Posted: July 10, 2012
Last Update Posted: July 11, 2012
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.
Collaborator:
World Health Organization
Information provided by (Responsible Party):
AB Foundation
July 3, 2012
July 10, 2012
July 11, 2012
July 2007
October 2009   (Final data collection date for primary outcome measure)
Cure rate [ Time Frame: 12 months after end of treatment ]
Same as current
No Changes Posted
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
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
Not Provided
Not Provided
 
Safety and Efficacy of Oral Miltefosine in Patients With Post Kala Azar Dermal Leishmaniasis (PKDL)
Not Provided
Miltefosine efficacy will be >85%
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
PKDL
  • Drug: Miltefosine
    2.5 mg/kg/day for 12 weeks
  • Drug: Miltefosine
    2.5 mg/kg/day for 8 weeks
  • Experimental: 12 weeks
    miltefosine 12 weeks
    Intervention: Drug: Miltefosine
  • Experimental: 8 weeks
    miltefosine 8 weeks
    Intervention: Drug: Miltefosine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
December 2010
October 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
12 Years to 65 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT01635777
Z015
No
Not Provided
Not Provided
AB Foundation
AB Foundation
World Health Organization
Not Provided
AB Foundation
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP