Patisiran-Lipid Nanoparticle (LNP) Pregnancy Surveillance Program

NCT ID: NCT05040373

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2030-10-12

Brief Summary

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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.

Detailed Description

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Conditions

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Hereditary Transthyretin-mediated (hATTR) Amyloidosis Polyneuropathy

Keywords

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Hereditary neuropathic amyloidosis Familial amyloidosis Amyloidosis Amyloidosis senile Cardiac amyloidosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Alnylam Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Alnylam Pharmaceuticals

Locations

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Clinical Trial Site

Iowa City, Iowa, United States

Site Status RECRUITING

Clinical Trial Site

Nantes, , France

Site Status RECRUITING

Clinical Trial Site

Münster, , Germany

Site Status RECRUITING

Clinical Trial Site

Pavia, , Italy

Site Status RECRUITING

Clinical Trial Site

Groningen, , Netherlands

Site Status RECRUITING

Clinical Trial Site

Lisbon, , Portugal

Site Status RECRUITING

Clinical Trial Site

Madrid, , Spain

Site Status RECRUITING

Countries

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United States France Germany Italy Netherlands Portugal Spain

Central Contacts

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Alnylam Clinical Trial Information Line

Role: CONTACT

Phone: 1-877-ALNYLAM

Email: [email protected]

Alnylam Clinical Trial Information Line

Role: CONTACT

Phone: 1-877-256-9526

Email: [email protected]

Other Identifiers

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ALN-TTR02-010

Identifier Type: -

Identifier Source: org_study_id