Leishmaniasis or Other Uses of Miltefosine
Conditions
Keywords
leishmaniasis, miltefosine, pregnancy
Brief 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.
Detailed description
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.
Interventions
DRUGMiltefosine
target dose = 2.5 mg/kg/day for 28 days
Sponsors
Knight Therapeutics (USA) Inc
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
\[none\]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of patients with adverse effects during pregnancy | 9 months |
| number of patients with adverse pregnancy outcome | 9 months |
| number of patients with adverse fetal outcome | at birth |
Countries
United States
Outcome results
None listed