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

This study has been completed.
Sponsor:
Collaborator:
World Health Organization
Information provided by (Responsible Party):
AB Foundation
ClinicalTrials.gov Identifier:
NCT01635777
First received: July 3, 2012
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

Miltefosine efficacy will be >85%


Condition Intervention Phase
PKDL
Drug: Miltefosine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01635777

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

No publications provided

Responsible Party: AB Foundation
ClinicalTrials.gov Identifier: NCT01635777     History of Changes
Other Study ID Numbers: Z015
Study First Received: July 3, 2012
Last Updated: July 9, 2012
Health Authority: India: Institutional Review Board

Keywords provided by AB Foundation:
PKDL
miltefosine

Additional relevant MeSH terms:
Leishmaniasis, Visceral
Leishmaniasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Miltefosine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents

ClinicalTrials.gov processed this record on April 17, 2014