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

Knight Therapeutics (USA) Inc · 2015
ClinicalTrials.gov · Datasets · License: Public Domain · 2015
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leishmaniasispregnancy
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.
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