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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
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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
Criteria

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
Information from the National Library of Medicine

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


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

Responsible Party: AB Foundation
ClinicalTrials.gov Identifier: NCT01635777     History of Changes
Other Study ID Numbers: Z015
First Submitted: July 3, 2012
First Posted: July 10, 2012
Last Update Posted: July 11, 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


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