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

NCT02427308 | Withdrawn

• 1 other identifier: IMP 2127-1
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Leishmaniasis or Other Uses of Miltefosine

Keywords

leishmaniasis; miltefosine; pregnancy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

miltefosine patients that become pregnant

Drug: Miltefosine

Interventions

Miltefosine DRUG

target dose = 2.5 mg/kg/day for 28 days

miltefosine patients that become pregnant

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

persons who become pregnant will taking miltefosine or for 5 months after taking miltefosine

You may qualify if:

• 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?

You may not qualify if:

• \[none\]

Sponsors & Collaborators

• Knight Therapeutics (USA) Inc: lead

Study Sites (1)

Fast Track

North Potomac, Maryland, United States

Location

MeSH Terms

Conditions

Leishmaniasis

Interventions

miltefosine

Condition Hierarchy (Ancestors)

Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Janet Ransom, PhD

  Fast Track Drugs and Biologics LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: April 28, 2015
• Study Start: July 1, 2015
• Primary Completion: March 28, 2025
• Study Completion: March 28, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

US (1)