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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02427308
Recruitment Status : Recruiting
First Posted : April 28, 2015
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Knight Therapeutics (USA) Inc

Tracking Information
First Submitted Date April 22, 2015
First Posted Date April 28, 2015
Last Update Posted Date March 7, 2018
Actual Study Start Date July 2015
Estimated Primary Completion Date March 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 24, 2015)
  • number of patients with adverse effects during pregnancy [ Time Frame: 9 months ]
  • number of patients with adverse pregnancy outcome [ Time Frame: 9 months ]
  • number of patients with adverse fetal outcome [ Time Frame: at birth ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Treatment of Leishmaniasis With Impavido® (Miltefosine): Pregnancy Registry
Official Title Treatment of Leishmaniasis With Impavido® (Miltefosine): Pregnancy Registry
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 9 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population persons who become pregnant will taking miltefosine or for 5 months after taking miltefosine
Condition Leishmaniasis or Other Uses of Miltefosine
Intervention Drug: Miltefosine
target dose = 2.5 mg/kg/day for 28 days
Study Groups/Cohorts miltefosine patients that become pregnant
Intervention: Drug: Miltefosine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 24, 2015)
2
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2026
Estimated Primary Completion Date March 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

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]

Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Katerina Ujhazy, MD 301-762-2609 kujhazy@fasttrackresearch.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02427308
Other Study ID Numbers IMP 2127-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Knight Therapeutics (USA) Inc
Study Sponsor Knight Therapeutics (USA) Inc
Collaborators Not Provided
Investigators
Principal Investigator: Janet Ransom, PhD Fast Track Drugs and Biologics LLC
PRS Account Knight Therapeutics (USA) Inc
Verification Date March 2018