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Treatment of Leishmaniasis With Impavido® (Miltefosine): Pregnancy Registry

NCT02427308 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2025-04-27

No results posted yet for this study

Summary

The purpose of this observational study is to fulfill FDA Post Marketing Requirement (PMR) 2127-1 for miltefosine (NDA204684): implement a pregnancy registry for the time period Mar 2015-Mar 2024.

This study is a prospective observational study in which female patients undergoing Impavido who become pregnant during treatment or within 5 months after completing treatment can volunteer to provide information about their pregnancy and the outcome of the pregnancy.

Conditions

  • Leishmaniasis or Other Uses of Miltefosine

Interventions

DRUG

Miltefosine

target dose = 2.5 mg/kg/day for 28 days

Sponsors & Collaborators

  • Knight Therapeutics (USA) Inc

    lead INDUSTRY

Principal Investigators

  • Janet Ransom, PhD · Fast Track Drugs and Biologics LLC

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2025-03-28
Completion
2025-03-28

Countries

  • United States

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 NCT02427308 on ClinicalTrials.gov