Nplate® Pregnancy Exposure Registry

NCT02090088 | Terminated Results DMC

• 1 other identifier: 20080046
• Study Type: observational
• Target: 4
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Birth Defect; Spontaneous Abortions; Low Birth Weight

Outcome Measures

Primary Outcomes (1)

• Number of Children Born With Major Birth Defects

  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 Outcomes (7)

• Number of Children Born With Any 3 or More Minor Birth Defects

  At birth

• Number of Children Born With a Specific Pattern of Minor Birth Defects

  At birth

• Number of Participants With Spontaneous and Elective Abortions or Stillbirths

  9 months (during pregnancy)

• Number of Children With Preterm Birth or Low Birth Weight

  At birth

• Number of Children Born With Intrauterine Growth Restriction

  At birth

Study Arms (1)

All Subjects

All Subjects

Drug: Not applicable- observational study

Interventions

Not applicable- observational study DRUG

All Subjects

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Congenital Abnormalities; Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Limitations and Caveats

The number of infants born to participants was too low to draw conclusions or make comparisons to the Systematic Tracking of Real Kids (STORK) analysis or to the background rates of congenital anomalies or preterm infants in the general population.

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 21 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2014
• First Posted: March 18, 2014
• Study Start: May 1, 2009
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 6, 2015
• Results First Posted: January 6, 2015

Record last verified: 2014-12