Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy

NCT02791230

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

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Pfizer Clinical Trials Contact Center

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Transthyretin (TTR) Amyloid Cardiomyopathy
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

Cohort A: Completion of 30 months of study treatment on Pfizer Protocol B3461028

Cohort B: Patients in specific countries diagnosed with ATTR-CM who did not previously participate in Pfizer Study B3461028

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


-Liver and/or heart transplant, or implanted cardiac mechanical assist device

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  42. Portland, Oregon
  43. Portland, Oregon
  44. Philadelphia, Pennsylvania
  45. Nashville, Tennessee
  46. Houston, Texas
  47. Salt Lake City, Utah
  48. Richmond, Virginia
  49. Richmond, Virginia
  50. Seattle, Washington
  51. Leuven,
  52. Rio de Janeiro, RJ
  53. Calgary, Alberta
  54. Toronto, Ontario
  55. Brno,
  56. Brno,
  57. Praha 2,
  58. Praha 2,
  59. Praha 4,
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  61. Clamart,
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Transthyretin (TTR) Amyloid CardiomyopathyLong-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy NCT02791230
  1. Baltimore, Maryland
  2. Birmingham, Alabama
  3. Birmingham, Alabama
  4. Birmingham, Alabama
  5. Beverly Hills, California
  6. Beverly Hills, California
  7. La Jolla, California
  8. La Jolla, California
  9. Los Angeles, California
  10. San Diego, California
  11. San Francisco, California
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  14. Stanford, California
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  18. Chicago, Illinois
  19. Chicago, Illinois
  20. Chicago, Illinois
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  23. Boston, Massachusetts
  24. Boston, Massachusetts
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  27. Ann Arbor, Michigan
  28. Rochester, Minnesota
  29. Rochester, Minnesota
  30. Newark, New Jersey
  31. New York, New York
  32. New York, New York
  33. Durham, North Carolina
  34. Cleveland, Ohio
  35. Portland, Oregon
  36. Portland, Oregon
  37. Portland, Oregon
  38. Philadelphia, Pennsylvania
  39. Nashville, Tennessee
  40. Salt Lake City, Utah
  41. Salt Lake City, Utah
  42. Salt Lake City, Utah
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  54. Montreal, Quebec
  55. Montreal, Quebec
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  58. Praha 4,
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  60. Creteil,
  61. Marseille,
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  68. Hong Kong,
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  70. Bologna,
  71. Firenze,
  72. Pavia,
  73. Kurume-shi, Fukuoka
  74. Kumamoto-city, Kumamoto
  75. Nagano,
  76. Groningen,
  77. Majadahonda, Madrid
  78. A Coruña,
  79. Skellefteå,
  80. Uppsala,
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Advanced Information
Descriptive Information
Brief Title  ICMJE Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy
Official Title  ICMJE A PHASE 3 MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY OF DAILY ORAL DOSING OF TAFAMIDIS MEGLUMINE (PF-06291826-83) 20 MG OR 80 MG [OR TAFAMIDIS (PF-06291826-00) 61 MG] IN SUBJECTS DIAGNOSED WITH TRANSTHYRETIN CARDIOMYOPATHY (ATTR-CM)
Brief Summary Open label study to evaluate tafamidis for the treatment of transthyretin cardiomyopathy
Detailed Description Global Phase 3, open label long term extension safety study designed to obtain additional safety data for tafamidis meglumine 20 mg and 80 mg (or tafamidis 61 mg where available), and to continue to provide enrolled subjects with tafamidis for up to 60 months, or until subject has access to tafamidis for ATTR CM via prescription, whichever occurs first.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Transthyretin (TTR) Amyloid Cardiomyopathy
Intervention  ICMJE Drug: Tafamidis
Soft gel capsules administered once a day for 60 months
Study Arms  ICMJE Experimental: Tafamidis
Active treatment - 61 mg or if not available, tafamidis megulmine 80 mg
Intervention: Drug: Tafamidis
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 29, 2019)
2000
Original Estimated Enrollment  ICMJE
 (submitted: June 1, 2016)
330
Estimated Study Completion Date  ICMJE January 2, 2027
Estimated Primary Completion Date December 24, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Cohort A: Completion of 30 months of study treatment on Pfizer Protocol B3461028

Cohort B: Patients in specific countries diagnosed with ATTR-CM who did not previously participate in Pfizer Study B3461028

Exclusion Criteria:

-Liver and/or heart transplant, or implanted cardiac mechanical assist device

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: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Canada,   Czechia,   France,   Germany,   Hong Kong,   Italy,   Japan,   Netherlands,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02791230
Other Study ID Numbers  ICMJE B3461045
2016-000868-42 ( EudraCT Number )
Has Data Monitoring Committee Yes
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