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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

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.


Condition or disease Intervention/treatment
Leishmaniasis or Other Uses of Miltefosine Drug: Miltefosine

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 9 Months
Official Title: Treatment of Leishmaniasis With Impavido® (Miltefosine): Pregnancy Registry
Actual Study Start Date : July 2015
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis
Drug Information available for: Miltefosine

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




Primary Outcome Measures :
  1. number of patients with adverse effects during pregnancy [ Time Frame: 9 months ]
  2. number of patients with adverse pregnancy outcome [ Time Frame: 9 months ]
  3. number of patients with adverse fetal outcome [ Time Frame: at birth ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
persons who become pregnant will taking miltefosine or for 5 months after taking miltefosine
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]


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427308


Contacts
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Contact: Katerina Ujhazy, MD 301-762-2609 kujhazy@fasttrackresearch.com

Locations
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United States, Maryland
Fast Track Recruiting
North Potomac, Maryland, United States
Contact: J Ransom         
Sponsors and Collaborators
Knight Therapeutics (USA) Inc
Investigators
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Principal Investigator: Janet Ransom, PhD Fast Track Drugs and Biologics LLC
Additional Information:

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Responsible Party: Knight Therapeutics (USA) Inc
ClinicalTrials.gov Identifier: NCT02427308    
Other Study ID Numbers: IMP 2127-1
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Keywords provided by Knight Therapeutics (USA) Inc:
leishmaniasis
miltefosine
pregnancy
Additional relevant MeSH terms:
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Leishmaniasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Miltefosine
Antifungal Agents
Anti-Infective Agents
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents