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

Sponsor
Intellia Therapeutics (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05697861
Collaborator
(none)
72
Enrollment
3
Locations
180
Anticipated Duration (Months)
24
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    72 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Long-Term Follow-Up of Subjects Treated With NTLA-2001
    Anticipated Study Start Date :
    Mar 1, 2023
    Anticipated Primary Completion Date :
    Mar 1, 2038
    Anticipated Study Completion Date :
    Mar 1, 2038

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Treatment-related SAEs and Protocol-specified AESIs [up to 15 years]

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

    Secondary Outcome Measures

    1. PD biomarkers for ATTR including serum TTR and serum prealbumin [up to 15 years]

      Long-term assessment of serum TTR and serum prealbumin

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Trial Site Auckland New Zealand
    2 Clinical Trial Site Umea Sweden
    3 Clinical Trial Site London United Kingdom

    Sponsors and Collaborators

    • Intellia Therapeutics

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Intellia Therapeutics
    ClinicalTrials.gov Identifier:
    NCT05697861
    Other Study ID Numbers:
    • ITL-2001-CL-999
    • 2022-003405-30
    First Posted:
    Jan 26, 2023
    Last Update Posted:
    Jan 26, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Polyneuropathies
    Amyloid Neuropathies
    Amyloid Neuropathies, Familial
    Cardiomyopathies
    Amyloidosis

    Study Results

    No Results Posted as of Jan 26, 2023