Phase II Randomized Study of Muromonab-CD3, Cyclosporine, Methylprednisolone, and Prednisone in Patients With Giant Cell Myocarditis
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|ClinicalTrials.gov Identifier: NCT00004482|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : September 9, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Myocarditis Giant Cell Myocarditis||Drug: Cyclosporine Drug: methylprednisolone Drug: Muromonab-CD3 Drug: prednisone||Phase 2|
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 cyclosporine)(arm 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||December 1999|
|Primary Completion Date :||July 2005|
|Study Completion Date :||July 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004482
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Leslie T. Cooper, Jr.||Mayo Clinic|