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

March 25, 2024 updated by: Intellia Therapeutics

Long-Term Follow-Up of Subjects Treated With NTLA-2001

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • New Zealand
      • Auckland, New Zealand
        • Recruiting
        • Clinical Trial Site
  • Sweden
      • Umea, Sweden
        • Recruiting
        • Clinical Trial Site
  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-related SAEs and Protocol-specified AESIs
Time Frame: up to 15 years
Long-term safety assessment of any treatment-related SAEs and protocol-specified AESIs
up to 15 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PD biomarkers for ATTR including serum TTR and serum prealbumin
Time Frame: up to 15 years
Long-term assessment of serum TTR and serum prealbumin
up to 15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intellia Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2023

Primary Completion (Estimated)

March 1, 2038

Study Completion (Estimated)

March 1, 2038

Study Registration Dates

First Submitted

January 13, 2023

First Submitted That Met QC Criteria

January 24, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITL-2001-CL-999
  • 2022-003405-30 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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