A Study to Learn About Tafamidis in Patients With Transthyretin Amyloid Cardiomyopathy (ATTR-CM) in India

Transthyretin Amyloid Cardiomyopathy Clinical Trial

Official title:

A Prospective, Single-arm, Multicenter, Observational Safety Surveillance Study of VyndaMx® (Tafamidis Capsule 61 mg) in Patients With Transthyretin Amyloid Cardiomyopathy (ATTR-CM) in India

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06086353
• Other study ID #: B3461106
• Status: Recruiting
• Start date: March 25, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to learn about the safety of Tafamidis for the treatment of Transthyretin amyloid cardiomyopathy (ATTR-CM) in India. ATTR-CM is a condition that affects people's hearts. Transthyretin is a protein that is made in the liver. In some people this protein stops working and forms clumps called as amyloid. Transthyretin amyloid builds up in heart and stops the heart from pumping properly. This study is seeking for participants who are: - confirmed with ATTR-CM. - given Tafamidis capsules to be taken by mouth. The safety of Tafamidis capsules will be checked based on side effects. These side effects can happen within 6 months after taking Tafamidis. A side effect is something (expected or unexpected) that you feel was caused by a medicine or treatment you take. The study doctor will collect side effect information and put the information on patient's case form. Follow-up of the patient's will be performed via clinic re-visit or over a call. It is not a rule for the participants to visit the clinic in this study. This study will help to see if Tafamidis is safe.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (age =18 years) with diagnosis of cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM).
• Patients to whom VyndaMx® Capsules is prescribed for the treatment of wild or hereditary ATTR-CM.

Exclusion Criteria:

• Patient with hypersensitivity to VyndaMx® Capsule or to any of the excipients in the product.
• Patients with rare hereditary problems of fructose intolerance.
• Patient who has a contraindication to VyndaMx® Capsules according to the approved local product label.

Related Conditions & MeSH terms

• Amyloidosis
• Cardiomyopathies
• Transthyretin Amyloid Cardiomyopathy

Intervention

Drug:
• Tafamidis
Patients on tafamidis will be observed

Locations

Country	Name	City	State
India	Sri Jayadeva Institute of Cardiovascular Sciences and Research	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse events with Tafamidis	The safety of VyndaMx® Capsules is the primary objective of the study and will be assessed based on Adverse events which would occur within 6 months from first dosing. Investigator will collect the safety related data until 6 months from first dosing of Tafamidis Capsules and will record these data on the Case report Form.	Baseline to 6 months

External Links

•   To obtain contact information for a study center near you, click here.