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OpenTrials
Completed

NCT Number: NCT01635777

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

Miltefosine efficacy will be >85%

Completed

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Key information

Conditions

PKDL

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institute of Medical Sciences, Banaras Hindu University,

Varanasi, 221005, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Miltefosine

Drug

2.5 mg/kg/day for 12 weeks

Primary outcomes

  1. Cure rate

    Time frame: 12 months after end of treatment

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

AB Foundation

Other

Collaborators

  • World Health Organization

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Jul 10, 2012
Registry last updated
Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.