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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004482

Enrollment

Registered

1999-10-19

Start date

1999-12-31

Completion date

2006-07-31

Last updated

2010-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocarditis, Giant Cell Myocarditis

Keywords

cardiovascular and respiratory diseases, giant cell myocarditis, rare disease

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.

Interventions

DRUGCyclosporine

DRUGmethylprednisolone

DRUGMuromonab-CD3

DRUGprednisone

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026