Korean Post-marketing Surveillance Vyndamax® Capsules for the Treatment of Transthyretin Amyloid Cardiomyopathy

Recruiting

• Conditions: ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
• Interventions: Drug: Vyndamax (tafamidis 61mg)

• Registration Number: NCT04801329
• Lead Sponsor: Pfizer

Brief Summary

This non-interventioal study will be performed by design of post-marketing surveillance (PMS) as an additional pharmacovigilance activity of the Risk Management Plan (RMP) for Vyndamax® Capsules, which is required by the Ministry of Food and Drug Safety (MFDS) according to the local regulation. This post-marketing surveillance will investigate the safety and effectiveness of Vyndamax® Capsules as the treatment of transthyretin amyloid cardiomyopathy during 10 years under the setting of routine practice in Korea.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-17
• Study Start: 2021-06-29
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-12
• Primary Completion: 2030-03-30
• Study Completion: 2030-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

• 1. Adult patients with the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM)
• 2. Patients to whom Vyndamax® Capsules is prescribed for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM)

• 3. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

  • Exclusion criteria

Patients meeting any of the following criteria will not be included in the study according to the local product label:

• 1. Patient with hypersensitivity or case history to tafamidis or to any of the excipients in the product
• 2. This product contains sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not take this medicine.
• 3. Patient who has a contraindication to Vyndamax® Capsules according to the approved local product label

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults diagnosed with transthyretin-mediated amyloidosis (ATTR-CM)	Vyndamax (tafamidis 61mg)	-

Primary Outcome Measures

Name	Time	Method
The incidence of Adverse Events (AEs)	Baseline through 6 months of treatment	The primary interest of this study is the incidence of AEs investigated during administration period and within 28 days after discontinuation of Vyndamax® Capsules. Incidence of AEs, 95% confidence interval and the number of AEs will be presented.; Serious AEs/ADRs, unexpected AEs/ADRs, unexpected serious AEs/ADRs will be summarized separately table.

Secondary Outcome Measures

Name	Time	Method
Global assessment by investigator at Month 6	Baseline, month 6
Change from baseline in the New York Heart Association (NYHA) class at Month 6	Baseline, month 6
Change from baseline in the 6 Minute Walk Distance (6MWD) at Month 6	Baseline, month 6

Trial Locations

Locations (1)

Pfizer; 🇰🇷 Seoul, Korea, Republic of