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NCT06262399 Clinical Trial

Long-Term Follow-Up (LTFU) of Subjects Treated With NTLA 2002

Hereditary Angioedema Clinical Trial

Official title:
Long-Term Follow-Up of Subjects Treated With NTLA 2002

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06262399
Other study ID # ITL-2002-CL-999
Secondary ID 2022-003778-22
Status Enrolling by invitation
Phase
First received
Last updated
Start date April 12, 2024
Est. completion date April 2040

Study information
Verified date January 2024
Source Intellia Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a follow-up study of subjects who received NTLA-2002 in a previous clinical trial as an observational evaluation of the long-term effects of the investigational therapy.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 100
Est. completion date April 2040
Est. primary completion date April 2040
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. A subject has completed or discontinued from an Intellia-sponsored or -supported treatment protocol in which a complete or partial dose of NTLA-2002 was received. 2. A subject has provided informed consent for the LTFU study. 3. A subject is willing to attend study visits, complete protocol-required follow-up schedule, and comply with the study requirements. Exclusion Criteria: None

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Centre National de Reference - Grenoble Grenoble
France Hôpital Claude Huriez Lille
Netherlands University of Amsterdam Academic Medical Center Amsterdam
New Zealand New Zealand Clinical Research Auckland
United Kingdom Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital Cambridge

Sponsors (1)
Lead Sponsor Collaborator
Intellia Therapeutics

Countries where clinical trial is conducted

France,  Netherlands,  New Zealand,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of treatment-related Adverse Events (AEs); incidence of treatment-related Serious Adverse Events (SAEs); incidence of treatment-related Adverse Events of Special Interest (AESIs) defined per protocol up to 15 years
Secondary To evaluate the long-term efficacy of NTLA-2002 in previously treated subjects Rate of Hereditary Angioedema (HAE) attacks overall and rate of HAE attacks requiring acute therapy. Total plasma kallikrein protein level. up to 15 years
Secondary Change from baseline in consumption of on-demand HAE medications for reported HAE attacks up to 15 years
Secondary Change from baseline in healthcare utilization for HAE attacks up to 15 years
Secondary Change from baseline in QoL parameters as measured by the MOXIE Angioedema-QoL instrument. up to 5 years
Secondary Change from baseline in QoL parameters as measured by the EQ-5D-5L instrument. up to 5 years
Secondary Change from baseline in QoL parameters as measured by the WPAI:GH instrument. up to 5 years
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