Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT04201418
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with ATTRv amyloidosis with polyneuropathy, with a documented V122I or T60A mutation
* PND score of I-IIIB at baseline.
* Exposure to commercial patisiran in one of the 3 cohorts:
* Prospective Cohort: Naive to patisiran treatment at the time of enrollment with intention to initiate treatment with patisiran.
* Mixed cohort: Currently on commercial patisiran therapy for less than 12 months at study enrollment.
* Retrospective cohort: Exposed to commercial patisiran treatment for at least 12 months prior to study enrollment, regardless of current treatment status at enrollment.
Exclusion Criteria:
* New York Heart Association (NYHA) heart failure classification ≥3
* Karnofsky Performance Status (KPS) \<60%
* Unstable congestive heart failure (CHF)
* Known primary amyloidosis (AL) or leptomeningeal amyloidosis
* Prior major organ transplant
* Previously received patisiran
* Previous treatment with a TTR silencing therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04201418
Study Brief:
Protocol Section:
NCT04201418