Patisiran-LNP Pregnancy Surveillance Program
Status: Recruiting
Location: See all (7) locations...
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:
• Documentation that the patient was exposed to patisiran-LNP at any point starting from 12 weeks before LMP or at any point during pregnancy
• Germany Only: Patients must be treated per the summary of product characteristics (SmPC) for any approved treatment for ATTR amyloidosis
Locations
United States
Iowa
Clinical Trial Site
RECRUITING
Iowa City
Other Locations
France
Clinical Trial Site
RECRUITING
Nantes
Germany
Clinical Trial Site
RECRUITING
Münster
Italy
Clinical Trial Site
RECRUITING
Pavia
Netherlands
Clinical Trial Site
RECRUITING
Groningen
Portugal
Clinical Trial Site
RECRUITING
Lisbon
Spain
Clinical Trial Site
RECRUITING
Madrid
Contact Information
Primary
Alnylam Clinical Trial Information Line
clinicaltrials@alnylam.com
1-877-ALNYLAM
Backup
Alnylam Clinical Trial Information Line
clinicaltrials@alnylam.com
1-877-256-9526
Time Frame
Start Date: 2020-08-01
Estimated Completion Date: 2030-10-12
Participants
Target number of participants: 10
Treatments
Patisiran
Pregnant women exposed to commercial patisiran-LNP (ONPATTRO) during the 12 weeks prior to their last menstrual period (LMP) or at any time during pregnancy.
Related Therapeutic Areas
Sponsors
Leads: Alnylam Pharmaceuticals