Ignite Creation Date:
2024-05-06 @ 12:12 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01511263
Status:
TERMINATED
Last Update Posted:
2018-03-21
First Post:
2012-01-10
Brief Title:
Epigallocatechingallate EGCG in Cardiac AL Amyloidosis
Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Organization:
Fondazione IRCCS Policlinico San Matteo di Pavia
Study Overview
Official Title:
A Phase II Open-label Randomized Study of Dietary Supplement With Epigallocatechin Gallate EGCG to Improve Cardiac Dysfunction in Patients With AL Amyloidosis Who do Not Require Chemotherapy EpiCardiAL
Status:
TERMINATED
Status Verified Date:
2018-03
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:
EpiCardiAL
Brief Summary:
In a proportion of patients with AL amyloidosis there is no improvement of cardiac function despite hematologic response to treatment The aim of the study is to assess whether treatment with EGCG increases the rate of cardiac response in patients with AL amyloidosis who completed chemotherapy
Detailed Description:
This will be a phase II open-label randomized trial Patients with AL amyloidosis and cardiac involvement who have achieved at least partial hematologic response after chemotherapy will be randomized to receive standard supportive therapy SST or SST plus Epigallocatechin gallate EGCG After giving written informed consent the patients will be evaluated for eligibility Briefly the subjects with a biopsy-proven diagnosis of AL amyloidosis who achieved at least partial response after chemotherapy who are not planned to receive further chemotherapy and who have significant cardiac dysfunction will be considered eligible The patients will be stratified according to the quality of hematologic response and to the severity of cardiac involvement Following stratification the patients will be randomized to receive SST or SST plus EGCG The study comprises 3 periods screening including stratification and randomization treatment with evaluations of response every 2 months followed by the end-of-treatment evaluation and follow-up Therapy will continue for up to 1 year After treatment patients will be followed for 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None