- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02090088
Nplate® Pregnancy Exposure Registry (NPER)
December 23, 2014 updated by: Amgen
Nplate® Pregnancy Exposure Registry (NPER)
US study to estimate the prevalence at birth of major birth defects (ie, those that cause significant functional or cosmetic impairment, require surgery, or are life-limiting) in children born to mothers who have received Nplate® therapy at any time during the pregnancy.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The purpose of the NPER is to monitor pregnancies exposed to Nplate® and to detect and record serious adverse events in infants up to one year after birth.
The lack of adequate human fetal safety data for Nplate® makes the NPER an important component of the pharmacovigilance program on the safety of this drug.
With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects that are visible at birth, as well as more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.
Study Type
Observational
Enrollment (Actual)
4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The study population consists of two cohorts of women and their offspring who reside in the U.S. The exposed cohort is defined as pregnant women who have received at least one dose of Nplate® during pregnancy and their offspring up to one year of age.
The unexposed cohort is defined as women unexposed to Nplate® during pregnancy matched on disease status (cITP) and age (childbearing) to the exposed.
In order to provide context for any possible Nplate® exposed women without cITP, comparators from published literature will be used.
Description
Inclusion Criteria:
- Eligible subjects will be currently pregnant women residing in the US who: Have had any exposure to Nplate® at any time during the pregnancy, which is defined as the period between first day of the last menstrual period (LMP) (ie, within two weeks of conception) up to any date before the date of delivery or end of the pregnancy. The date of conception will be defined as fourteen days prior to the next expected menstrual period for women who report a regular menstrual cycle. If the date of the first day of the LMP is unclear, or if the estimated date of conception as determined by a first-trimester ultrasound differs by more than one week from the date as determined by the first day of LMP, the first-trimester ultrasound-derived date will be used to estimate the timing of exposure to Nplate®, as well as timing of enrollment. If neither a clear date of the first day of the LMP nor a first-trimester ultrasound is available, the estimated date of conception for purposes of enrollment will be determined by best estimate of the woman's prenatal care provider.
- Agree to enroll at any time from the estimated date of conception up to any date before the date of delivery or end of the pregnancy and who have not already had prenatal diagnosis of any major structural birth defect in the current pregnancy prior to enrollment.
- Agree to provide consent for participation in the registry including follow-up interviews.
Exclusion Criteria:
- Subjects will be ineligible for study participation if any of the following apply:
- Exposure to Nplate® did not occur during pregnancy.
- Prior knowledge of prenatal diagnosis of a birth defect. Patients who fall under this category will be encouraged to call the Amgen PSP toll free number for enrollment and follow-up.
- Cases reported to the NPER after completion of the exposed pregnancy. Patients who fall under this category will be encouraged to call the Amgen PSP toll free number for enrollment and follow-up.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
All Subjects
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Children Born With Major Birth Defects
Time Frame: At birth
|
An external, independent Congenital Malformation Adjudication Panel (CMAP) comprised of two clinical dysmorphologists and/or teratologists organized malformations based upon organ system and embryology, and determined whether structural defects were major or minor according to a modification of the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system.
A major structural defect is defined as a defect which has either cosmetic or functional significance to the child (eg, a cleft lip), require surgery, or are life-limiting).
|
At birth
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Children Born With Any 3 or More Minor Birth Defects
Time Frame: At birth
|
An external, independent Congenital Malformation Adjudication Panel (CMAP) comprised of two clinical dysmorphologists and/or teratologists organized malformations based upon organ system and embryology, and determined whether structural defects were major or minor according to a modification of the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system.
A minor structural defect is defined as a defect which occurs in less than 4% of the population but which has neither cosmetic nor functional significance to the child (eg, complete 2,3 syndactyly of the toes).
|
At birth
|
Number of Children Born With a Specific Pattern of Minor Birth Defects
Time Frame: At birth
|
Only those infants who have received medical evaluation and who have three or more minor defects will be considered "affected" for purposes of the evaluation of a pattern of minor defects.
|
At birth
|
Number of Participants With Spontaneous and Elective Abortions or Stillbirths
Time Frame: 9 months (during pregnancy)
|
Number of each of spontaneous abortions, elective abortions, and stillbirths among mothers who received Nplate® therapy at any time during the pregnancy.
|
9 months (during pregnancy)
|
Number of Children With Preterm Birth or Low Birth Weight
Time Frame: At birth
|
Number of children with preterm birth (<37 weeks gestation) or low birth weight (<2,500 grams) among children born to mothers who have received Nplate® therapy at any time during the pregnancy.
|
At birth
|
Number of Children Born With Intrauterine Growth Restriction
Time Frame: At birth
|
Number of children born with intrauterine growth restriction (weight, length or head circumference less than tenth percentile for sex and gestational age) among mothers who have received Nplate® therapy at any time during the pregnancy.
|
At birth
|
Number of Infants With Adverse Events
Time Frame: 12 months from birth
|
In the first year of life, the incidence of all serious adverse events, as well as of nevi (birthmarks) and angiomata (benign tumors with blood vessels or lymph vessels), among infants whose mothers received Nplate® therapy at any time during the pregnancy.
|
12 months from birth
|
Number of Participants With Adverse Events
Time Frame: Throughout pregnancy and for up to 6 weeks after delivery
|
Throughout pregnancy and for up to 6 weeks after delivery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
March 14, 2014
First Submitted That Met QC Criteria
March 14, 2014
First Posted (Estimate)
March 18, 2014
Study Record Updates
Last Update Posted (Estimate)
January 6, 2015
Last Update Submitted That Met QC Criteria
December 23, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20080046
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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