Ignite Creation Date:
2024-05-06 @ 3:58 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04828993
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2021-03-17
Brief Title:
The Effect Of Tafamidis Meglumine In Transthyretin Amyloid Polyneuropathy Patients
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A SINGLE ARM MULTICENTER OPEN-LABEL STUDY TO EVALUATE THE EFFICACY SAFETY TOLERABILITY AND PHARMACODYNAMICS OF ORALLY ADMINISTERED TAFAMIDIS MEGLUMINE IN TRANSTHYRETIN AMYLOID POLYNEUROPATHY PARTICIPANTS IN CHINA
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-arm open-label multicenter study designed to evaluate the efficacy safety tolerability as well as pharmacodynamics of tafamidis meglumine in ATTR-PN participants in China
Approximately 10-15 participants are planned to be enrolled All enrolled participants will receive oral tafamidis meglumine 20 mg soft capsules once daily for 72 weeks 18 months
Approximately 10-15 participants are planned to be enrolled All enrolled participants will receive oral tafamidis meglumine 20 mg soft capsules once daily for 72 weeks 18 months
Detailed Description:
This is a single-arm open-label multicenter study designed to evaluate the efficacy safety tolerability as well as pharmacodynamics of tafamidis meglumine in ATTR-PN participants in China
All enrolled participants will receive oral tafamidis meglumine 20 mg soft capsules once daily starting on Day 1 Clinical visits will be scheduled at Baseline Day 1 and at Week 4 Week 8 Week 12 Week 24 Week 36 Week 48 Week 60 and Week 72 At Week 36 and Week 60 site visit assessment of adverse events safety related lab testings concomitant medications and investigational product compliance will be scheduled Every 6 weeks do not exceed 7 weeks since last confirmation telephone contacts will be made during visits in which no investigative site visits are scheduled for assessment of adverse events concomitant medications and investigational product compliance between Week 12 and 24 between Week 24 and 36 between Week 36 and 48 between Week 48 and 60 and between Week 60 and 72
All enrolled participants will receive oral tafamidis meglumine 20 mg soft capsules once daily starting on Day 1 Clinical visits will be scheduled at Baseline Day 1 and at Week 4 Week 8 Week 12 Week 24 Week 36 Week 48 Week 60 and Week 72 At Week 36 and Week 60 site visit assessment of adverse events safety related lab testings concomitant medications and investigational product compliance will be scheduled Every 6 weeks do not exceed 7 weeks since last confirmation telephone contacts will be made during visits in which no investigative site visits are scheduled for assessment of adverse events concomitant medications and investigational product compliance between Week 12 and 24 between Week 24 and 36 between Week 36 and 48 between Week 48 and 60 and between Week 60 and 72
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None