Last updated: 08/02/2024 15:10:13
The Mepolizumab Pregnancy Exposure Study: a VAMPSS post marketing surveillance study of Mepolizumab safety in pregnancy
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: The Mepolizumab Pregnancy Exposure Study: a VAMPSS post marketing surveillance study of Mepolizumab safety in pregnancy
Trial description: The Mepolizumab Pregnancy Exposure Study is a prospective, observational, exposure cohort study of pregnancy outcomes in women exposed to mepolizumab during pregnancy compared to pregnancy outcomes in women who have not used mepolizumab during pregnancy but have used other anti-asthmatic medications (treated disease comparison group), and pregnancy outcomes in women exposed to other non-teratogenic agents (non-asthmatic comparison group). This study is a voluntary post marketing commitment to the European Medicines Agency. The purpose of the study is to monitor planned and unplanned pregnancies exposed to mepolizumab and to evaluate the possible teratogenic effect of this medication relative to the primary pregnancy outcome of major birth defects and the secondary pregnancy outcomes of preterm delivery, small for gestational age infants and spontaneous abortion or stillbirth. The study is conducted by the Organization of Teratology Information Specialists (OTIS) Research Center located at the University of California, San Diego. The target sample size for the study is 200 women in the mepolizumab-exposed cohort, 300 women in the treated disease cohort, and 300 women in the non-asthmatic cohort. Upon initiation of recruitment, the study is expected to continue for 6.5 years.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Major structural defects among live born infants
Timeframe: Up to 1 year post birth
Secondary outcomes:
Preterm delivery
Timeframe: Up to 1 year post birth
Small for gestational age infants
Timeframe: Up to 1 year post birth
Spontaneous abortion
Timeframe: Up to 40 weeks post LMP
Stillbirth
Timeframe: Up to 40 weeks post LMP
Interventions:
Enrollment:
291
Primary completion date:
2024-03-02
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Asthma
Product
mepolizumab
Collaborators
University of California SanDiego coordinating center for Organization of Teratology Information Specialists (OTIS)
Study date(s)
November 2016 to February 2024
Type
Observational
Phase
4
Participation criteria
Sex
Female
Age
Not applicable
Accepts healthy volunteers
Not applicable
- Cohort 1 Mepolizumab Exposed: Eligible subjects will be currently pregnant women diagnosed with asthma who contact the OTIS Research Center and who have been exposed to mepolizumab for any number of days, at any dose, and at anytime from 8 weeks before the first day of the LMP up to and including the end of pregnancy; Eligible subjects will be currently pregnant women who agree to the conditions and requirements of the study including the interview schedule and release of medical records.
- Cohort 2 Treated Disease Comparison: Eligible subjects will be currently pregnant women diagnosed with asthma and who are exposed to asthma medications for any number of days, at any dose, and at anytime from the first day of the LMP up to the date of enrollment, who contact the OTIS Research Center but who were not exposed to mepolizumab during pregnancy or within 8 weeks prior to the first day of the LMP; Eligible subjects will be currently pregnant women who agree to the conditions and requirements of the study including the interview schedule and release of medical records.
- Cohort 1 Mepolizumab Exposed: Women will not be eligible for Cohort 1 if they first contact the OTIS Research Center after prenatal diagnosis of a major birth defect, although data will be collected on these retrospective reports and descriptive information will be included in annual and final study reports; Women will not be eligible for Cohort 1 if they have enrolled in the study with a previous pregnancy.
- Cohort 2 Treated Disease Comparison: Women who have received treatment with mepolizumab but who are not eligible for Cohort 1 will not be eligible for Cohort 2; Women will not be eligible for Cohort 2 if they first come in contact with the OTIS Research Center after prenatal diagnosis of a major birth defect; Women will not be eligible for Cohort 2 who have enrolled in the study with a previous pregnancy.
Inclusion and exclusion criteria
Inclusion criteria:
- Cohort 1 Mepolizumab Exposed: Eligible subjects will be currently pregnant women diagnosed with asthma who contact the OTIS Research Center and who have been exposed to mepolizumab for any number of days, at any dose, and at anytime from 8 weeks before the first day of the LMP up to and including the end of pregnancy; Eligible subjects will be currently pregnant women who agree to the conditions and requirements of the study including the interview schedule and release of medical records.
- Cohort 2 Treated Disease Comparison: Eligible subjects will be currently pregnant women diagnosed with asthma and who are exposed to asthma medications for any number of days, at any dose, and at anytime from the first day of the LMP up to the date of enrollment, who contact the OTIS Research Center but who were not exposed to mepolizumab during pregnancy or within 8 weeks prior to the first day of the LMP; Eligible subjects will be currently pregnant women who agree to the conditions and requirements of the study including the interview schedule and release of medical records.
- Cohort 3 Non-Asthmatic Comparison: Eligible subjects will be currently pregnant women who contact the OTIS Research Center who were not exposed to any known teratogenic agents as determined by the OTIS Research Center for any number of days, at any dose, from the first day of the LMP up to and including the end of pregnancy, and who do not have a current self reported diagnosis of asthma. Eligible women may potentially have been exposed to non-teratogenic agents during this time period; Eligible subjects will be currently pregnant women who agree to the conditions and requirements of the study including the interview schedule and release of medical records.
Exclusion criteria:
- Cohort 1 Mepolizumab Exposed: Women will not be eligible for Cohort 1 if they first contact the OTIS Research Center after prenatal diagnosis of a major birth defect, although data will be collected on these retrospective reports and descriptive information will be included in annual and final study reports; Women will not be eligible for Cohort 1 if they have enrolled in the study with a previous pregnancy.
- Cohort 2 Treated Disease Comparison: Women who have received treatment with mepolizumab but who are not eligible for Cohort 1 will not be eligible for Cohort 2; Women will not be eligible for Cohort 2 if they first come in contact with the OTIS Research Center after prenatal diagnosis of a major birth defect; Women will not be eligible for Cohort 2 who have enrolled in the study with a previous pregnancy.
- Cohort 3 Non-Asthmatic Comparison: Women who have been exposed to any known teratogenic agents as determined by the OTIS Research Center for any number of days, at any dose, from the first day of the LMP up to and including the end of pregnancy will not be eligible for Cohort 3; Women will not be eligible for Cohort 3 if they have a current self-reported diagnosis of asthma; Women will not be eligible for Cohort 3 if they come in contact with the OTIS Research Center after prenatal diagnosis of a major birth defect; Women will not be eligible for Cohort 3 if they have enrolled in the study with a previous pregnancy.
- Other exclusions: Any pregnancy reported retrospectively, after the outcome is known, will not be eligible for enrollment but those that are reported, including those with adverse outcomes, will be referred to the Sponsor.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2024-03-02
Actual study completion date
2024-03-02
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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