Monitoring pregnancy outcomes in women exposed to patisiran-LNP
Patisiran-LNP Pregnancy Surveillance Program
This study is looking to see how patisiran-LNP affects pregnancy and baby outcomes in women who have been treated with it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Sex | Female |
| Sponsor | Alnylam Pharmaceuticals Industry-sponsored |
| Locations | 7 sites (Iowa City, Iowa and 6 other locations) |
| Trial ID | NCT05040373 on ClinicalTrials.gov |
What this trial studies
This observational program aims to collect and evaluate pregnancy outcomes, complications, and fetal/neonatal/infant outcomes in women who have been exposed to patisiran-LNP. The study will gather data from participants who were exposed to the treatment starting from 12 weeks before their last menstrual period or at any point during their pregnancy. By analyzing this data, the program seeks to understand the safety and effects of patisiran-LNP during pregnancy.
Who should consider this trial
Good fit: Ideal candidates for this program are women who have been exposed to patisiran-LNP during pregnancy or in the 12 weeks prior to their last menstrual period.
Not a fit: Patients who have not been exposed to patisiran-LNP or who are not pregnant may not receive any benefit from this program.
Why it matters
Potential benefit: If successful, this program could provide valuable insights into the safety of patisiran-LNP during pregnancy, helping to inform treatment decisions for women with hATTR amyloidosis.
How similar studies have performed: While this program is focused on pregnancy outcomes related to patisiran-LNP, similar observational studies have shown success in evaluating treatment safety during pregnancy.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Iowa City, Iowa and 6 other locations
- Clinical Trial Site — Iowa City, Iowa, United States (Recruiting)
- Clinical Trial Site — Nantes, France (Recruiting)
- Clinical Trial Site — Münster, Germany (Recruiting)
- Clinical Trial Site — Pavia, Italy (Recruiting)
- Clinical Trial Site — Groningen, Netherlands (Recruiting)
- Clinical Trial Site — Lisbon, Portugal (Recruiting)
- Clinical Trial Site — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Alnylam Clinical Trial Information Line
- Email: clinicaltrials@alnylam.com
- Phone: 1-877-ALNYLAM
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.