Long-Term Follow-Up (LTFU) of Subjects Dosed With NTLA-2001

N/AEnrolling By InvitationNCT05697861

Intellia Therapeutics72 enrolled

Overview

This is a follow-up study of subjects who received NTLA-2001 in a previous clinical trial as an observational evaluation of the long-term effects of the investigational therapy.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Transthyretin-Related (ATTR) Familial Amyloid Polyneuropathy Transthyretin-Related (ATTR) Familial Amyloid Cardiomyopathy Wild-Type Transthyretin Cardiac Amyloidosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. A subject has completed or discontinued from an Intellia-sponsored clinical study in which a complete or partial dose of NTLA-2001 was received. 2. A subject has provided informed consent for the LTFU study. Exclusion Criteria: None

Locations (4)

Clinical Trial Site

Paris, France

Clinical Trial Site

Auckland, New Zealand

Clinical Trial Site

Umeå, Sweden

Clinical Trial Site

London, United Kingdom

Outcomes

Primary Outcomes

Incidence of Treatment-related SAEs and Protocol-specified AESIs

Long-term safety assessment of any treatment-related SAEs and protocol-specified AESIs

Time frame: up to 15 years

Secondary Outcomes

PD biomarkers for ATTR including serum TTR and serum prealbumin

Long-term assessment of serum TTR and serum prealbumin

Time frame: up to 15 years

Data from ClinicalTrials.gov

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