Safety And Efficacy Evaluation Of Fx-1006A In Subjects With Transthyretin Amyloidosis

NCT00925002

Last updated date
Study Location
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
ATTR-PN
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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ATTR-PNSafety And Efficacy Evaluation Of Fx-1006A In Subjects With Transthyretin Amyloidosis NCT00925002
  1. Baltimore, Maryland
  2. Ciudad Autonoma de Buenos aires,
  3. Rio de Janeiro, RJ
  4. Creteil cedex,
  5. Muenster,
  6. Pavia,
  7. Pavia,
  8. Pavia,
  9. Pavia,
  10. Lisboa,
  11. Porto,
  12. Umea,
  13. Umea,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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 Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE ATTR-PN
Intervention  ICMJE Drug: Tafamidis
20 mg oral Fx-1006A daily
Study Arms  ICMJE Active Comparator: Open-Label
Intervention: Drug: Tafamidis
Publications *

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 28, 2017)
93
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2009)
100
Estimated Study Completion Date  ICMJE May 30, 2020
Estimated Primary Completion Date May 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP