Long-term follow-up of patients treated with NTLA-2001
Long-Term Follow-Up of Subjects Treated With NTLA-2001
This study looks at how NTLA-2001 has affected people with certain types of amyloidosis over the long term after they were treated in a previous trial.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Intellia Therapeutics Industry-sponsored |
| Locations | 4 sites (Paris and 3 other locations) |
| Trial ID | NCT05697861 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the long-term effects of NTLA-2001 in patients who have previously participated in an Intellia-sponsored clinical trial. It focuses on individuals diagnosed with transthyretin-related familial amyloid polyneuropathy, familial amyloid cardiomyopathy, or wild-type transthyretin cardiac amyloidosis. Participants will be monitored to assess the ongoing impact of the investigational therapy over time. The study does not involve new interventions but rather collects data on the outcomes of those previously treated.
Who should consider this trial
Good fit: Ideal candidates are individuals who have completed or discontinued from a previous clinical trial involving NTLA-2001.
Not a fit: Patients who have not received NTLA-2001 in prior studies will not benefit from this follow-up study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and efficacy of NTLA-2001 for patients with amyloid-related conditions.
How similar studies have performed: While this study is observational and follows previous trials, similar long-term follow-up studies have shown success in providing critical data on investigational therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris and 3 other locations
- Clinical Trial Site — Paris, France (Recruiting)
- Clinical Trial Site — Auckland, New Zealand (Recruiting)
- Clinical Trial Site — Umeå, Sweden (Recruiting)
- Clinical Trial Site — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Trial Manager at Intellia
- Email: medicalinformation@intelliatx.com
- Phone: 1-857-285-6200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.