PregnancyNCT02399839
Global Lomitapide Pregnancy Exposure Registry
An observational study of Pregnancy, run by Amryt Pharma at 1 site in Germany.
Trial summary
To evaluate the outcomes of pregnancy in women treated with lomitapide. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- lomitapide
- How many people
- 5 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to Dec 2022
- How long will I take part?
- 2 Years
- 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: Pregnant Females
Who may be able to join
- Pregnant females exposed to lomitapide at any time within 30 days prior to first day of the LMP or during pregnancy.
Who cannot join
- Patients who are unable or unwilling to provide written informed consent or assent are not eligible to participate in the PER.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the outcomes of pregnancy in women treated with lomitapide.
Read the detailed description
To evaluate the outcomes of pregnancy in women treated with lomitapide at any time within 30 days prior to first day of Last Menstrual Period (LMP) or during pregnancy. The outcomes of primary interest are major congenital anomalies.
- Conditions
- Pregnancy
- Being tested
- lomitapide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lomitapideDrug
Also called Juxtapid, Lojuxta
As prescribed by Physician.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy
To evaluate the outcomes of pregnancy in women treated with lomitapide at any time within 30 days prior to first day of Last Menstrual Period (LMP) or during pregnancy. The outcomes of primary interest are major congenital anomalies.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2022
- Study completionDec 2022
Why it stopped: The PER objective has been integrated into the LOWER protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Amryt Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sallyann O'Brien, Study director, Amryt Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399839
- Sponsor's protocol ID
- AEGR-733-027
- Status last verified
- Dec 2022
- First submitted
- 23 Mar 2015
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Lomitapide Pregnancy Exposure Registry
- ClinicalTrials.gov ID
- NCT02399839
- Acronym / sponsor ID
- AEGR-733-027
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The PER objective has been integrated into the LOWER protocol.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Amryt PharmaIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 26 Mar 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.
To evaluate the outcomes of pregnancy in women treated with lomitapide.
Detailed description
To evaluate the outcomes of pregnancy in women treated with lomitapide at any time within 30 days prior to first day of Last Menstrual Period (LMP) or during pregnancy. The outcomes of primary interest are major congenital anomalies.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant Females
Key inclusion criteria (1 listed)
- Pregnant females exposed to lomitapide at any time within 30 days prior to first day of the LMP or during pregnancy.
Key exclusion criteria (1 listed)
- Patients who are unable or unwilling to provide written informed consent or assent are not eligible to participate in the PER.
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 |
|---|---|---|
| lomitapideAlso: Juxtapid, LojuxtaAs prescribed by Physician. | Drug | – |
Primary outcome
Pregnancy
Time frame: 2 Years
To evaluate the outcomes of pregnancy in women treated with lomitapide at any time within 30 days prior to first day of Last Menstrual Period (LMP) or during pregnancy. The outcomes of primary interest are major congenital anomalies.
Results and safety
The study was stopped early (reason given: The PER objective has been integrated into the LOWER protocol.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
Related trials for Pregnancy
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Active, not recruitingPhase 2
Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation
Muscle-Invasive Bladder Carcinoma, Programmed Cell Death Protein 1 Inhibitor
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
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.
Sallyann O'Brien study director
Amryt Pharmaceuticals
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 Pregnancy, run by Amryt Pharma at 1 site in Germany.
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 1 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: stopped early, as of the sponsor's last update on 16 Dec 2022. 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 Germany. 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 stopped early (reason given: The PER objective has been integrated into the LOWER protocol.). Results are not available in the source record.
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?
Pregnancy (time frame: 2 Years). 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 16 Dec 2022.