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

Launched by KNIGHT THERAPEUTICS (USA) INC · Apr 24, 2015

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called Impavido® (miltefosine) for treating leishmaniasis, a disease caused by parasites. Specifically, the trial is looking to gather information about the effects of this treatment on pregnant women. If a woman received Impavido and then became pregnant during her treatment or within five months after finishing it, she can choose to participate in this study. By volunteering, she would share details about her pregnancy and the outcome, helping researchers understand how miltefosine may affect pregnancy.

To be eligible for this study, participants need to be women who have received Impavido and became pregnant during or shortly after their treatment. There are no major exclusions, so most women who meet these criteria can join. Participants can expect to provide information about their pregnancy experiences, and their privacy will be protected as data will be collected with consent from them or their guardians. This study will help ensure that the safety of Impavido during pregnancy is well understood.

Gender

FEMALE

Eligibility 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:
• • \[none\]