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Report for Clinical Trial NCT00935012
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
This is a Phase 3, open-label study designed to obtain additional, long-term, safety and
efficacy data for tafamidis, and to continue to provide subjects who have completed Protocol
Fx1B-201 (a Phase 2, open-label study to evaluate TTR stabilization, as well as the safety
and tolerability of tafamidis) with 20 mg oral tafamidis (soft gelatin capsule) for up to 10
years or until subject has access to tafamadis for TTR-CM via prescription.
Name: tafamidis
Description: Once daily 20 mg oral tafamidis (soft gelatin capsule)
Type: Drug
Group Labels: 1 Open-Label
Primary Outcomes
Measure: Percentage of patients with a change from baseline through 10 years in Global Assessment Summary Score Time: Baseline up to 10 years
Measure: Percentage of patients with a change from baseline through 10 years in New York Heart Association Classification Time: Baseline up to 10 years
Measure: Percentage of patients with a change from baseline through 10 years in their 6-minute walk test distance Time: Baseline up to 10 years
Measure: Percentage of patients with a change from baseline through 10 years in their Kansas City Cardiomyopathy Questionnaire Summary Score Time: Baseline up to 10 years
Measure: Percentage of patients with a clinically significant change from baseline through 10 years in their echocardiography test Time: Baseline up to 10 years
Measure: Percentage of all patients with a clinically significant change from baseline through 10 years in serum levels of NT-proBNP, troponin I or troponin T Time: Baseline up to 10 years
Measure: Number or percentage of patients with a mortality or hospitalization event within 10 years of study participation Time: Baseline up to 10 years
Secondary Outcomes
Measure: Incidence of Treatment-Emergent Adverse Events from baseline through 10 years Time: Baseline up to 10 years
Purpose: Treatment
Allocation: N/A
Single Group Assignment
There is one SNP
SNPs
1 V122I
Open-label, Safety and Efficacy Evaluation of FX-1006A in Patients With V122I or Wild-type Transthyretin (TTR) Amyloid Cardiomyopathy. --- V122I ---
Safety And Efficacy Evaluation Of Fx-1006a In Patients With V122I Or Wild-Type ATTR-CM
This is a Phase 3, open-label study designed to obtain additional, long-term, safety and
efficacy data for tafamidis, and to continue to provide subjects who have completed Protocol
Fx1B-201 (a Phase 2, open-label study to evaluate TTR stabilization, as well as the safety
and tolerability of tafamidis) with 20 mg oral tafamidis (soft gelatin capsule) for up to 10
years or until subject has access to tafamadis for TTR-CM via prescription. --- V122I ---
HPO Nodes
HPO: