Back to resultsPhase II Randomized Study of Muromonab-CD3, Cyclosporine, Methylprednisolone, and Prednisone in Patients With Giant Cell Myocarditis
Primary Purpose
Myocarditis, Giant Cell Myocarditis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cyclosporine
methylprednisolone
Muromonab-CD3
prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Myocarditis focused on measuring cardiovascular and respiratory diseases, giant cell myocarditis, rare disease
Eligibility Criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Idiopathic giant cell myocarditis confirmed by endomyocardial biopsy Heart failure and/or arrhythmia of less than 3 months duration --Patient Characteristics-- Hepatic: AST/ALT no greater than 3 times upper limit of normal Renal: Creatinine no greater than 2.5 mg/dL Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No clinical evidence of sepsis or active infection (e.g. meningitis, osteomyelitis, etc.); No contraindication to immunosuppression; No allergy to cyclosporine or muromonab-CD3; No other severe concurrent diseases
Sites / Locations
- Mayo Clinic
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00004482
Brief Title
Phase II Randomized Study of Muromonab-CD3, Cyclosporine, Methylprednisolone, and Prednisone in Patients With Giant Cell Myocarditis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocarditis, Giant Cell Myocarditis
Keywords
cardiovascular and respiratory diseases, giant cell myocarditis, rare disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cyclosporine
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Intervention Type
Drug
Intervention Name(s)
Muromonab-CD3
Intervention Type
Drug
Intervention Name(s)
prednisone
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Idiopathic giant cell myocarditis confirmed by endomyocardial biopsy
Heart failure and/or arrhythmia of less than 3 months duration
--Patient Characteristics--
Hepatic: AST/ALT no greater than 3 times upper limit of normal
Renal: Creatinine no greater than 2.5 mg/dL
Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No clinical evidence of sepsis or active infection (e.g. meningitis, osteomyelitis, etc.); No contraindication to immunosuppression; No allergy to cyclosporine or muromonab-CD3; No other severe concurrent diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie T. Cooper, Jr.
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase II Randomized Study of Muromonab-CD3, Cyclosporine, Methylprednisolone, and Prednisone in Patients With Giant Cell Myocarditis
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