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

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

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorIntellia Therapeutics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

A subject has completed or discontinued from an Intellia-sponsored clinical study in which a complete or partial dose of NTLA-2001 was received.

A subject has provided informed consent for the LTFU study.

Disqualifiers

None

Trial population

Participating sites in an Intellia-sponsored clinical study of NTLA-2001.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial 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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Intellia Therapeutics

Lead sponsor

Source ClinicalTrials.gov

Apply now