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

July 9, 2012 updated by: AB Foundation
Miltefosine efficacy will be >85%

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Varanasi, India, 221005
        • Institute of Medical Sciences, Banaras Hindu University,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 12 weeks
miltefosine 12 weeks
Drug: Miltefosine
2.5 mg/kg/day for 12 weeks
Drug: Miltefosine
2.5 mg/kg/day for 8 weeks
Experimental: 8 weeks
miltefosine 8 weeks
Drug: Miltefosine
2.5 mg/kg/day for 12 weeks
Drug: Miltefosine
2.5 mg/kg/day for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cure rate
Time Frame: 12 months after end of treatment
12 months after end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during therapy: the 8 weeks of therapy for the 8 week treatment group and 12 weeks of therapy for the 12 week treatment group

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AB Foundation

Collaborators

World Health Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

July 3, 2012

First Submitted That Met QC Criteria

July 9, 2012

First Posted (Estimate)

July 10, 2012

Study Record Updates

Last Update Posted (Estimate)

July 10, 2012

Last Update Submitted That Met QC Criteria

July 9, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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