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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-003778-22 | EudraCT Number |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change from baseline in consumption of on-demand HAE medications for reported HAE attacks |
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Inclusion Criteria:
Exclusion Criteria:
None
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Participating sites in an Intellia-sponsored clinical study of NTLA-2002.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Campbelltown Hospital | Campbelltown | New South Wales | 2560 | Australia | ||
| Centre National de Reference - Grenoble |
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| ID | Term |
|---|---|
| D054179 | Angioedemas, Hereditary |
| ID | Term |
|---|---|
| D000799 | Angioedema |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000081208 | Hereditary Complement Deficiency Diseases |
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Serum
| up to 15 years |
| Change from baseline in healthcare utilization for HAE attacks | up to 15 years |
| Change from baseline in QoL parameters as measured by the MOXIE Angioedema-QoL instrument. | up to 5 years |
| Change from baseline in QoL parameters as measured by the EQ-5D-5L instrument. | up to 5 years |
| Change from baseline in QoL parameters as measured by the WPAI:GH instrument. | up to 5 years |
| Grenoble |
| France |
| Hôpital Claude Huriez | Lille | 59037 | France |
| Charite-Universitätsmedizin Berlin | Berlin | 12203 | Germany |
| University of Amsterdam Academic Medical Center | Amsterdam | Netherlands |
| New Zealand Clinical Research | Auckland | New Zealand |
| Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital | Cambridge | United Kingdom |
| D000081207 | Primary Immunodeficiency Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D007153 | Immunologic Deficiency Syndromes |