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

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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?

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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