WithdrawnNot Applicable

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

Stopped: Study completed and no patients registered

United States0Started 2015-07

Plain-language 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.

Who can participate

SexFEMALE

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Inclusion criteria

✓. Has the subject received Impavido?
✓. Is the subject a female?
✓. Did the subject become pregnant during Impavido treatment or within 5 months after completing treatment?
✓. Did the subject or legal guardian give consent/assent for the study and to collect data from her physicians?

What they're measuring

number of patients with adverse effects during pregnancy

Timeframe: 9 months

number of patients with adverse pregnancy outcome

Timeframe: 9 months

number of patients with adverse fetal outcome

Timeframe: at birth

Trial details

NCT IDNCT02427308

SponsorKnight Therapeutics (USA) Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-03-28

View on ClinicalTrials.gov More Leishmaniasis or Other Uses of Miltefosine trials