Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004482
Status:
COMPLETED
Last Update Posted:
2010-09-09
First Post:
1999-10-18
Brief Title:
Phase II Randomized Study of Muromonab-CD3 Cyclosporine Methylprednisolone and Prednisone in Patients With Giant Cell Myocarditis
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2010-09
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:
OBJECTIVES
I Assess the effect of immunosuppression with muromonab-CD3 cyclosporine methylprednisolone and prednisone versus standard care in terms of death heart transplantation or left ventricular assistive device placement in patients with giant cell myocarditis
II Compare left ventricular ejection fraction prior to and after 4 weeks of treatment in these arms
III Compare the degree of myocardial inflammatory infiltrate prior to and after 4 weeks of treatment in these arms
I Assess the effect of immunosuppression with muromonab-CD3 cyclosporine methylprednisolone and prednisone versus standard care in terms of death heart transplantation or left ventricular assistive device placement in patients with giant cell myocarditis
II Compare left ventricular ejection fraction prior to and after 4 weeks of treatment in these arms
III Compare the degree of myocardial inflammatory infiltrate prior to and after 4 weeks of treatment in these arms
Detailed Description:
PROTOCOL OUTLINE
This is a randomized open label multicenter study
Patients are randomized to receive standard care with immunosuppression arm I or standard care with or without immunosuppression no muromonab-CD3 or cyclosporinearm II
Arm I Patients receive methylprednisolone IV once daily for 3 days and muromonab-CD3 IV once daily for 10 days Oral cyclosporine is administered twice daily and oral prednisone is administered once daily for 1 year
Arm II Patients receive standard care with or without immunosuppression no muromonab-CD3 or cyclosporine
Patients are followed for one year
This is a randomized open label multicenter study
Patients are randomized to receive standard care with immunosuppression arm I or standard care with or without immunosuppression no muromonab-CD3 or cyclosporinearm II
Arm I Patients receive methylprednisolone IV once daily for 3 days and muromonab-CD3 IV once daily for 10 days Oral cyclosporine is administered twice daily and oral prednisone is administered once daily for 1 year
Arm II Patients receive standard care with or without immunosuppression no muromonab-CD3 or cyclosporine
Patients are followed for one year
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 |
|---|---|---|---|
| MAYOC-1479900 | None | None | None |
| MAYOC-1479901 | None | None | None |