Phase II Randomized Study of Muromonab-CD3, Cyclosporine, Methylprednisolone, and Prednisone in Patients With Giant Cell Myocarditis

NCT00004482 | Completed Phase 2 DMC

• 3 other identifiers: 199/14209MAYOC-1479901MAYOC-1479900
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocarditis; Giant Cell Myocarditis

Keywords

cardiovascular and respiratory diseases; giant cell myocarditis; rare disease

Interventions

Cyclosporine DRUG

methylprednisolone DRUG

Muromonab-CD3 DRUG

prednisone DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Myocarditis; Respiratory Tract Diseases; Rare Diseases

Interventions

Cyclosporine; Methylprednisolone; Muromonab-CD3; Prednisone

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Immunoglobulin G; Immunoglobulin Isotypes; Serum Globulins; Globulins; Pregnadienediols

Study Officials

• Leslie T. Cooper, Jr.

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 18, 1999
• First Posted: October 19, 1999
• Study Start: December 1, 1999
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2006
• Last Updated: September 9, 2010

Record last verified: 2010-09

Locations

US (1)