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

• Status: Recruiting
• Trial end date: 2026-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Knight Therapeutics (USA) Inc
• Treatments: Miltefosine

Criteria

Inclusion Criteria:

1. Has the subject received Impavido?

2. Is the subject a female?

3. Did the subject become pregnant during Impavido treatment or within 5 months after completing treatment?

4. Did the subject or legal guardian give consent/assent for the study and to collect data from her physicians?

Exclusion Criteria:

[none]