Safety And Efficacy Evaluation Of Fx-1006A In Subjects With Transthyretin Amyloidosis
NCT00925002
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- 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
- 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.
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Descriptive Information | |||||||
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Brief Title ICMJE | Safety And Efficacy Evaluation Of Fx-1006A In Subjects With Transthyretin Amyloidosis | ||||||
Official Title ICMJE | OPEN-LABEL SAFETY AND EFFICACY EVALUATION OF FX-1006A IN SUBJECTS WITH TRANSTHYRETIN (TTR) AMYLOIDOSIS | ||||||
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 study continued to provide tafamidis to Val30Met subjects who had completed Protocol Fx-006 (a 1-year, open-label extension study to Protocol Fx-005 which was a randomized, double-blind, placebo-controlled, 18-month study to evaluate the safety and efficacy of tafamidis) or non-Val30Met subjects who had completed Protocol Fx1A-201 (a Phase 2, open-label study to evaluate TTR stabilization, safety, and tolerability of tafamidis) for up to 10 years or until subjects had access to tafamidis for ATTR-PN via prescription. Upon regulatory approval for the treatment of ATTR-PN in their respective country and access to prescription tafamidis, subjects may have been withdrawn from the study. Such subjects were considered study completers. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: N/A Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | ATTR-PN | ||||||
Intervention ICMJE | Drug: Tafamidis
20 mg oral Fx-1006A daily | ||||||
Study Arms ICMJE | Not Provided | ||||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 93 | ||||||
Original Estimated Enrollment ICMJE | 100 | ||||||
Actual Study Completion Date ICMJE | July 8, 2020 | ||||||
Actual Primary Completion Date | July 8, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Key Inclusion criteria:
Key Exclusion criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Argentina, Brazil, France, Germany, Italy, Portugal, Sweden, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00925002 | ||||||
Other Study ID Numbers ICMJE | FX1A-303 B3461023 ( Other Identifier: Alias Study Number ) 2009-011535-12 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | January 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |