Hereditary Angioedema Clinical Trial
Official title:
Long-Term Follow-Up of Subjects Treated With NTLA 2002
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.
| Status | Not yet recruiting |
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre National de Reference - Grenoble | Grenoble | |
| France | Hôpital Claude Huriez | Lille | |
| New Zealand | New Zealand Clinical Research | Auckland | |
| United Kingdom | Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital | Cambridge |
| Lead Sponsor | Collaborator |
|---|---|
| Intellia Therapeutics |
France, New Zealand, United Kingdom,
| 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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