Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027443
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2001-12-05
Brief Title:
Study of Muromonab-CD3 and Cyclosporine in Patients With Giant Cell Myocarditis
Sponsor:
Mayo Clinic
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
Giant Cell Myocarditis Treatment Trial Pilot Study
Status:
COMPLETED
Status Verified Date:
2001-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study to determine the efficacy of muromonab-CD3 and cyclosporine as treatment in patients with giant cell myocarditis GCM T lymphocytes appear to be involved in GCM Muromonab-CD3 has been shown to reduce the number of lymphocytes and cyclosporine inhibits lymphocyte activation This treatment may prolong patient survival until transplantation or ventricular assist device placement is possible
Detailed Description:
Each patient will be randomized to receive either standard care and immunosuppression therapy treatment group or standard care alone control group To prevent bias randomization will be stratified by recency of symptom onset to ensure that both the treatment and control groups are balanced with respect to it Within each of these 2 strata permuted-block randomization will be done to keep the number of treatment and control patients balanced Due to the necessary monitoring of the patients randomized to receive immunosuppression therapy treatment cannot be blinded Approximately 1 year after the last patient has been randomized the observed times from randomization to the composite endpoint death transplantation or LVD placement will be compared in the treatment and control groups
Completion date provided represents the completion date of the grant per OOPD records
Completion date provided represents the completion date of the grant per OOPD records
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FD-R-001986-0 | None | None | None |