Leishmaniasis or Other Uses of Miltefosine Clinical Trial
Official title:
Treatment of Leishmaniasis With Impavido® (Miltefosine): Pregnancy Registry
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.
Objective: 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.
Study Design: 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. Information will be collected from patient's provider of Impavido treatment,
obstetrical treatment, and if applicable, the child's pediatrician.
Population: Leishmaniasis patients or patients who take Impavido off-label who become
pregnant while taking Impavido or within 5 months after taking Impavido.
Drug Product:
Drug name: Impavido (50 mg capsules). Dosing regimen: as per the Impavido Product Label (PL)
Study Procedures: Pregnant women will become aware of the Impavido Pregnancy Registry via the
product label (PL) or the Impavido website or her physician. By calling 1-866-588-5405, the
patient will be connected to the Impavido Pregnancy Registry Coordinating Center. A trained
staff member will acquaint the patient with the goals and procedures of the study. If the
patient tentatively agrees to participate in the study over the telephone, the patient will
be mailed information forms, the Consent Form and Assent Form as appropriate, and the Consent
for the patient's physician and obstetrician and the child's pediatrician to release medical
information. Receipt of the four signed Consent Forms and Assent Form as appropriate by the
Coordinating Center will signify patient and/or legal guardian consent/assent. The
Coordinating Center will contact the patient and/or the patient's physicians each trimester
until delivery to collect data on maternal adverse events (AEs), pregnancy outcome, and fetal
outcome.
Sample Size And Study Duration: Estimated 0-1 patients per year for 10 years.
Outcome Parameters:
Maternal AEs. Pregnancy outcome. Fetal outcome.
Analysis Plan: Baseline data, compliance to prescribed treatment, and outcomes will be
reported for individual patients and for all patients.
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