A Study to Learn About Tafamidis in Patients With Transth... | NCT06086353

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

NCT06086353

Sponsor

Pfizer

Status

Completed

Last Update Posted

Nov 20, 2025Actual

Enrollment

6Actual

Phase

Not provided

Conditions

Transthyretin Amyloid Cardiomyopathy

Interventions

Tafamidis

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCT06086353	Registry Identifier	ClinicalTrials.gov

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 25, 2024Actual

Primary Completion Date

Jun 6, 2025Actual

Completion Date

Jun 6, 2025Actual

First Submitted Date

Oct 11, 2023

First Submission Date that Met QC Criteria

Oct 11, 2023

First Posted Date

Oct 17, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2025

Last Update Posted Date

Nov 20, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with ATTR-CM in India			Drug: Tafamidis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tafamidis	Drug	Patients on tafamidis will be observed	Patients with ATTR-CM in India

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients diagnosed with ATTR-CM and prescribed with VyndaMx® Capsule 61 mg according to routine clinical practice at 3 centers in India and willing to participate will be included in the study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sri Jayadeva Institute of Cardiovascular Sciences and Research		Bangalore	Karnataka	560069	India

References Module

Citations

Not provided