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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT02939820
Eligibility Criteria:
Inclusion Criteria:
* Male or female greater than or equal to 18 years of age
* Have a diagnosis of hATTR
* Meet Karnofsky performance status and Polyneuropathy Disability (PND) score requirements
* Have adequate complete blood counts, liver function tests and coagulation tests
Exclusion Criteria:
* Participated in an interventional hATTR amyloidosis clinical trial involving RNA interference (RNAi) therapeutics within the last 12 months
* Are currently eligible to participate in or currently enrolled in an ongoing interventional hATTR amyloidosis clinical trial
* Have inadequate cardiac function
* Known primary amyloidosis (AL amyloidosis) or leptomeningeal amyloidosis
* Have known serious comorbidities or considered unfit for the program by the investigator
* Prior or planned liver or heart transplantation
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02939820
Study Brief:
Protocol Section:
NCT02939820