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

NCT ID: NCT01635777

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-12-31

Brief Summary

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Miltefosine efficacy will be \>85%

Detailed Description

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Conditions

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PKDL

Keywords

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PKDL miltefosine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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12 weeks

miltefosine 12 weeks

Group Type EXPERIMENTAL

Miltefosine

Intervention Type DRUG

2.5 mg/kg/day for 12 weeks

8 weeks

miltefosine 8 weeks

Group Type EXPERIMENTAL

Miltefosine

Intervention Type DRUG

2.5 mg/kg/day for 8 weeks

Interventions

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Miltefosine

2.5 mg/kg/day for 12 weeks

Intervention Type DRUG

Miltefosine

2.5 mg/kg/day for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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World Health Organization

OTHER

Sponsor Role collaborator

AB Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Medical Sciences, Banaras Hindu University,

Varanasi, , India

Site Status

Countries

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India

Other Identifiers

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Z015

Identifier Type: -

Identifier Source: org_study_id