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

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

RECRUITING

Clinical Trial Site

Auckland, New Zealand

RECRUITING

Clinical Trial Site

Umeå, Sweden

RECRUITING

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

Central Contacts

Trial Manager at Intellia

CONTACT

1-857-285-6200 medicalinformation@intelliatx.com

Data from ClinicalTrials.gov

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