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

History of Changes

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:

Genetic and Rare Diseases Information Center resources: Leishmaniasis

U.S. FDA Resources

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

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, see Learn About Clinical Studies.

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:


Miltefosine Anti-Infective Agents Antifungal Agents Antineoplastic Agents	Antiparasitic Agents Antiprotozoal Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

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