Status:
COMPLETED
Safety And Efficacy Evaluation Of Fx-1006a In Patients With V122i Or Wild-Type Transthyretin (TTR) Amyloid Cardiomyopathy
Lead Sponsor:
Pfizer
Conditions:
ATTR-CM
TTR-CM
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Open-label Safety and Efficacy Evaluation of Fx-1006a in Patients with V122i Or Wild-type Transthyretin (ttr) Amyloid Cardiomyopathy. Patients who successfully complete Fx1B-201 will report to the cl...
Eligibility Criteria
Inclusion
- Patient successfully completed Protocol Fx1B-201.
- If female; patient is post menopausal. If male, female partner is post-menopausal. If female is of child bearing potential, willing to use acceptable method of birth control up to 3 months after last dose (included female partners of male participants).
- Patient is willing to comply with protocol.
Exclusion
- Patient did not successfully complete Fx1B-201.
- Chronic use of NSAIDS.
- Patient has a clinically significant medication condition that increases risk of study participation.
- Patient has received heart or liver transplant.
Key Trial Info
Start Date :
September 30 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2019
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00935012
Start Date
September 30 2009
End Date
November 20 2019
Last Update
January 5 2021
Active Locations (7)
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1
Emory University School of Medicine
Atlanta, Georgia, United States, 30322-4510
2
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
3
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
4
University of Chicago
Chicago, Illinois, United States, 60637