Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT05697861
NCT05697861Enrolling By InvitationNot Applicable

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

Intellia Therapeutics5 sites in 4 countries72 target enrollmentStarted: July 10, 2023Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
72
Locations
5
Primary Endpoint
Incidence of Treatment-related SAEs and Protocol-specified AESIs
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • PD biomarkers for ATTR including serum TTR and serum prealbumin(up to 15 years)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (5)

Loading locations...

Similar Trials

Unknown
Not Applicable
Long-Term Follow-Up (LTFU) of Subjects Treated With NTLA 2002Hereditary Angioedema
NCT06262399Intellia Therapeutics100
Recruiting
Phase 1
ong-Term Follow-Up of Subjects Treated With NTLA-2001-Hereditary Transthyretin Amyloidosis with Polyneuropathy (ATTRv-PN)-Transthyretin Amyloidosis-Related Cardiomyopathy (ATTR-CM)MedDRA version: 20.0Level: PTClassification code: 10019889Term: Hereditary neuropathic amyloidosis Class: 100000004850MedDRA version: 20.0Level: PTClassification code: 10007509Term: Cardiac amyloidosis Class: 100000004849
CTIS2023-507385-11-00Intellia Therapeutics Inc.72
Recruiting
Phase 1
ong-Term Follow-Up of Subjects Treated With NTLA-2002MedDRA version: 20.0Level: PTClassification code: 10019860Term: Hereditary angioedema Class: 100000004850Hereditary Angioedema
CTIS2023-507956-56-00Intellia Therapeutics Inc.29
Completed
Not Applicable
Long Term Follow Up Protocol for NiCord®/CordIn™ (Omidubicel) PatientsPatients Transplanted With NiCord/CordIn (Omidubicel)
NCT02039557Gamida Cell ltd33
Completed
Phase 2
The Study of ALN-TTR02 (Patisiran) for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Patients Who Have Already Been Treated With ALN-TTR02 (Patisiran)TTR-mediated Amyloidosis
NCT01961921Alnylam Pharmaceuticals27