Status:
COMPLETED
Safety And Efficacy Evaluation Of Fx-1006A In Subjects With Transthyretin Amyloidosis
Lead Sponsor:
Pfizer
Conditions:
ATTR-PN
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a Phase 3, open-label study designed to obtain additional long-term safety and efficacy data for oral tafamidis (20 mg soft gelatin capsule) administered once daily (QD). In addition, this stu...
Eligibility Criteria
Inclusion
- Key Inclusion criteria:
- Subject had successfully completed either Protocol Fx-006 or Fx-1A-201.
- Male or female subjects with ATTR-PN who had not undergone liver or heart transplantation at time of enrollment.
- If female, subject was post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control
- Key Exclusion criteria:
- Chronic use of non-protocol approved non-steroidal anti-inflammatory drugs (NSAIDs)
- Pregnant or breast feeding female subjects.
- Clinically significant medical condition that, in the opinion of the investigator, would place the subject at an increased risk to participate in the study.
- An alanine aminotransferase (ALT) and aspartate aminotransferase (AST) value \>3 × upper limit of normal (ULN) that, in the medical judgment of the investigator, was due to reduced liver function or active liver disease.
- Sexually active males with partners of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least 3 months after last dose of study drug.
Exclusion
Key Trial Info
Start Date :
August 5 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2020
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00925002
Start Date
August 5 2009
End Date
July 8 2020
Last Update
July 29 2021
Active Locations (9)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
2
FLENI
Buenos Aires, Argentina, C1428AQK
3
Hospital Universitário Clementino Fraga Filho -HUCFF Universidade Federal do Rio de Janeiro
Rio de Jameiro, R.J., Brazil, 21941-913
4
Centre d'Investigation Clinique
Créteil, France, 94010