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:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT01171859
Eligibility Criteria:
Inclusion Criteria:
* Histochemical diagnosis of amyloidosis as based on detection by polarizing microscopy of green birefringent material in Congo red-stained tissue specimens;
* Molecular definition of the transthyretin (TTR) mutation or immunohistochemical staining of amyloid fibrils with anti-TTR antibody;
* ECOG performance status (PS) 0, 1, 2;
* New York Heart Association (NYHA) class ≤III
* Systolic blood pressure ≥100 mmHg (standing)
* Must have symptomatic organ involvement with amyloid to justify therapy; must have evidence of neuropathy and/or cardiomyopathy progression after liver transplantation performed since at least one year.
* Contraception for women of childbearing potential. Medically approved contraception could include abstinence. A negative serum pregnancy test is required prior to initiation of treatment with study medication.
Exclusion Criteria:
* Liver transplantation in the previous 12 months or liver transplantation anticipated in less than 6 months;
* ALT and/or AST ≥ 2 x Upper Normal Limit (UNL);
* Alkaline phosphatase ≥ 2 x UNL;
* Creatinine clearance \< 30 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;
* Echocardiographic ejection fraction \< 50%;
* Other neuropathies, due to vitamin B12 deficiency, alcoholism, hypothyroidism, uremia, diabetes mellitus, vasculitides;
* History of poor compliance;
* History of hypersensitivity to any of the ingredients of the study therapies;
* Use of any investigational drug, device (or biologic) within 4 weeks prior to study entry or during the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01171859
Study Brief:
Protocol Section:
NCT01171859