Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Muromonab-CD3, Cyclosporine, Methylprednisolone, and Prednisone in Giant Cell Myocarditis
NCT00004482Phase 2
Key facts
- Status
- Completed
- Start
- Dec 1999
- Primary completion
- Jul 2005
- Countries
- 1
- Sponsor
- Mayo Clinic
- Modality
- Small Molecules, Peptides, Monoclonal Antibodies
- Conditions
- Giant cell myocarditis (GCM)
01
Overview
Phase 2, randomised, open-label trial of muromonab-CD3 and cyclosporine in Giant cell myocarditis (GCM) (2 arms), sponsored by Mayo Clinic. Primary endpoint: Death, heart transplantation, or left ventricular assistive device placement at 1 year. Started Dec 1999; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Standard care + Immunosuppression
Methylprednisolone IV once daily for 3 days, muromonab-CD3 IV once daily for 10 days, oral cyclosporine twice daily, and oral prednisone once daily for 1 year.
Standard care
Standard care with or without immunosuppression (no muromonab-CD3 or cyclosporine).
03
Who it enrols
Patients with idiopathic giant cell myocarditis confirmed by biopsy, with heart failure/arrhythmia of <3 months duration, adequate hepatic and renal function, and no active infection or contraindication to immunosuppression.
04
Endpoints
Primary
Death, heart transplantation, or left ventricular assistive device placement
Secondary
Left ventricular ejection fraction
Degree of myocardial inflammatory infiltrate
Beyond the preview
Go deeper on NCT00004482.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT00004482.