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 @ 2:14 AM
Ignite Modification Date:
2025-12-25 @ 2:14 AM
NCT ID:
NCT01855360
Eligibility Criteria:
Inclusion Criteria:
* Documented transthyretin cardiac amyloidosis by biopsy and staining using immunohistochemistry or mass spectrometry
* Echocardiographic appearance of left ventricular wall thickness of 13mm or more in the absence of hypertensive heart disease
* Confirmed ATTR or SSA by genetic testing
* Age 18-90
* Male or non-pregnant, non-lactating females
* Willingness to return to the treatment center for follow-up
Exclusion Criteria:
* Prior liver transplantation or liver transplantation anticipated in less than 6 months
* Alanine Transaminase and/or Aspartate Transaminase ≥2 x upper normal limit (UNL)
* Alkaline Phosphatase ≥2 x UNL
* Creatinine clearance \<20 mL/min
* Any other lab values that in the opinion of the investigator might place the subject at unacceptable risk for participation in the study
* History of poor compliance
* History of hypersensitivity to any of the ingredients of the study therapies
* Any investigational drug within 4 weeks prior to study entry or during the study
* Current use of diflunisal for therapy of amyloidosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01855360
Study Brief:
Protocol Section:
NCT01855360