Patisiran-Lipid Nanoparticle (LNP) Pregnancy Surveillance Program

Polyneuropathy Clinical Trial

Official title:

Patisiran-LNP Pregnancy Surveillance Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05040373
• Other study ID #: ALN-TTR02-010
• Status: Recruiting
• Start date: August 1, 2020
• Est. completion date: October 12, 2030

Study information

• Verified date: May 2024
• Source: Alnylam Pharmaceuticals
• Contact: Alnylam Clinical Trial Information Line
• Phone: 1-877-ALNYLAM
• Email: clinicaltrials[@]alnylam.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to collect and evaluate pregnancy outcomes, pregnancy complications, and fetal/neonatal/infant outcomes in women exposed to patisiran-LNP.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 12, 2030
• Est. primary completion date: October 12, 2030
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Documentation that the patient was exposed to patisiran-LNP at any point starting from 12 weeks before LMP or at any point during pregnancy

Exclusion Criteria:

• There are no exclusion criteria for participation in this program.

Related Conditions & MeSH terms

• Amyloidosis
• Polyneuropathies
• Polyneuropathy

Locations

Country	Name	City	State
France	Clinical Trial Site	Nantes
Germany	Clinical Trial Site	Münster
Italy	Clinical Trial Site	Pavia
Netherlands	Clinical Trial Site	Groningen
Portugal	Clinical Trial Site	Lisboa
Spain	Clinical Trial Site	Madrid
United States	Clinical Trial Site	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Alnylam Pharmaceuticals

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  Netherlands,  Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Major Congenital Malformations	Major congenital malformations will be classified according to the European Concerted Action on Congenital Anomalies and Twins (EUROCAT) and Metropolitan Atlanta Congenital Defects Program (MACDP) classification systems.	From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)
Secondary	Prevalence of Minor Congenital Malformations	Minor congenital malformations will be classified classified according to the EUROCAT and MACDP classification systems.	From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)
Secondary	Prevalence of Pregnancy Outcomes	Pregnancy outcomes are defined as live birth, spontaneous abortions, stillbirths, elective abortions, molar or pregnancy, ectopic pregnancy, preterm births, and maternal death.	From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)
Secondary	Prevalence of Other Adverse Fetal/Neonatal/Infant Outcomes	Other adverse fetal/neonatal/infant outcomes are defined as low birth weight, failure to thrive, small for gestational age, postnatal growth and development, neonatal, and perinatal, or infant death.	From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)