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

March 6, 2018 updated by: Knight Therapeutics (USA) Inc

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • North Potomac, Maryland, United States
        • Recruiting
        • Fast Track
        • Contact:
          • J Ransom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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]

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
miltefosine patients that become pregnant
Drug: Miltefosine
target dose = 2.5 mg/kg/day for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of patients with adverse effects during pregnancy
Time Frame: 9 months
9 months
number of patients with adverse pregnancy outcome
Time Frame: 9 months
9 months
number of patients with adverse fetal outcome
Time Frame: at birth
at birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Knight Therapeutics (USA) Inc

Investigators

  • Principal Investigator: Janet Ransom, PhD, Fast Track Drugs and Biologics LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

March 1, 2026

Study Registration Dates

First Submitted

April 22, 2015

First Submitted That Met QC Criteria

April 24, 2015

First Posted (Estimate)

April 28, 2015

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 6, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMP 2127-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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