Ignite Creation Date:
2024-05-06 @ 11:18 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03481972
Status:
COMPLETED
Last Update Posted:
2024-07-11
First Post:
2018-03-16
Brief Title:
A Study of Doxycycline and Tauroursodeoxycholic Acid DoxyTUDCA Plus Standard Supportive Therapy Versus Standard Supportive Therapy Alone in Cardiac Amyloidosis Caused by Transthyretin
Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Organization:
Fondazione IRCCS Policlinico San Matteo di Pavia
Study Overview
Official Title:
A Phase III Randomized Study of Doxycycline and Tauroursodeoxycholic Acid DoxyTUDCA Plus Standard Supportive Therapy Versus Standard Supportive Therapy Alone in Cardiac Amyloidosis Caused by Transthyretin
Status:
COMPLETED
Status Verified Date:
2024-07
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:
Cardiac amyloidosis caused by transthyretin either mutated in ATTRm amyloidosis or wildtype in ATTRwt formerly senile amyloidosis is a rare disease but is diagnosed with increasing frequency thanks to the availability of non-invasive scintigraphy-based means Cardiac ATTR amyloidosis is characterized by progressive heart failure with a median survival of less than 4 years and there is no standard treatment for this disease It was proved that the marketed antibiotic doxycycline Doxy disrupts amyloid fibrils in vitro and in animal models synergistically with tauroursodeoxycholic acid TUDCA Based on these pre-clinical data a clinical trial of DoxyTUDCA in ATTR Amyloidosis NCT01171859 was conducted
Treatment was well tolerated and was able to prevent progression of cardiac dysfunction
Treatment was well tolerated and was able to prevent progression of cardiac dysfunction
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None