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Dedicated QT Study in Bolivian Patients Taking Impavido® (Miltefosine) for Mucocutaneous Leishmaniasis

NCT02429518 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2020-09-04

No results posted yet for this study

Summary

This study is a Phase 4, open-label, single group study in which at least 40 adult patients undergoing miltefosine treatment for mucocutaneous leishmaniasis (CL and ML) will be assessed by 12-lead ECG for prolongation of the corrected QT interval

Conditions

  • Mucocutaneous Leishmaniasis

Interventions

DRUG

Miltefosine

Sponsors & Collaborators

  • Knight Therapeutics (USA) Inc

    lead INDUSTRY

Principal Investigators

  • Jaime Soto, MD · Fundacion Nacional de Dermatologia

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-06-06
Completion
2018-03-06

Countries

  • Bolivia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02429518 on ClinicalTrials.gov