Leishmaniasis or Other Uses of MiltefosineNCT02427308
Treatment of Leishmaniasis With Impavido® (Miltefosine): Pregnancy Registry
An observational study of Leishmaniasis or Other Uses of Miltefosine, run by Knight Therapeutics (USA) Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Leishmaniasis or Other Uses of Miltefosine
- What is being tested?
- Miltefosine
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 28 Mar 2025
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: persons who become pregnant will taking miltefosine or for 5 months after taking miltefosine
Who may be able to join
- 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?
Who cannot join
- [none]
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Miltefosine
- Keywords
- leishmaniasis, miltefosine, pregnancy
- Medical subject headings
- Leishmaniasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiltefosineDrug
target dose = 2.5 mg/kg/day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| miltefosine patients that become pregnant | Not described Receives: Drug: Miltefosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with adverse effects during pregnancy
Measured: 9 months
number of patients with adverse pregnancy outcome
Measured: 9 months
number of patients with adverse fetal outcome
Measured: at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startJul 2015
- Primary completion28 Mar 2025
- Study completion28 Mar 2025
Why it stopped: Study completed and no patients registered
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leishmaniasis or Other Uses of MiltefosineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Knight Therapeutics (USA) Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janet Ransom, PhD, Principal investigator, Fast Track Drugs and Biologics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427308
- Sponsor's protocol ID
- IMP 2127-1
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2015
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Leishmaniasis With Impavido® (Miltefosine): Pregnancy Registry
- ClinicalTrials.gov ID
- NCT02427308
- Acronym / sponsor ID
- IMP 2127-1
- Keywords
- leishmaniasis, miltefosine, pregnancy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study completed and no patients registered
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Knight Therapeutics (USA) IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2015 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 28 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| miltefosine patients that become pregnant | – | Drug: Miltefosine |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- persons who become pregnant will taking miltefosine or for 5 months after taking miltefosine
Key inclusion criteria (4 listed)
- 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?
Key exclusion criteria (1 listed)
- [none]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Miltefosinetarget dose = 2.5 mg/kg/day for 28 days | Drug | miltefosine patients that become pregnant |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet Ransom, PhD principal investigator
Fast Track Drugs and Biologics LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leishmaniasis or Other Uses of Miltefosine, run by Knight Therapeutics (USA) Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with adverse effects during pregnancy (time frame: 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.