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Study of Muromonab-CD3 and Cyclosporine in Patients With Giant Cell Myocarditis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00027443
Recruitment Status : Completed
First Posted : December 7, 2001
Last Update Posted : March 25, 2015
Information provided by:
FDA Office of Orphan Products Development

Brief Summary:
This is a study to determine the efficacy of muromonab-CD3 and cyclosporine as treatment in patients with giant cell myocarditis (GCM). T lymphocytes appear to be involved in GCM. Muromonab-CD3 has been shown to reduce the number of lymphocytes and cyclosporine inhibits lymphocyte activation. This treatment may prolong patient survival until transplantation or ventricular assist device placement is possible.

Condition or disease Intervention/treatment Phase
Myocarditis Drug: Muromonab-CD3 Drug: Cyclosporine Not Applicable

Detailed Description:

Each patient will be randomized to receive either standard care and immunosuppression therapy (treatment group) or standard care alone (control group). To prevent bias, randomization will be stratified by recency of symptom onset to ensure that both the treatment and control groups are balanced with respect to it. Within each of these 2 strata, permuted-block randomization will be done to keep the number of treatment and control patients balanced. Due to the necessary monitoring of the patients randomized to receive immunosuppression therapy, treatment cannot be blinded. Approximately 1 year after the last patient has been randomized, the observed times from randomization to the composite endpoint (death, transplantation, or LVD placement) will be compared in the treatment and control groups.

Completion date provided represents the completion date of the grant per OOPD records

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Giant Cell Myocarditis Treatment Trial Pilot Study
Study Start Date : August 2001
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Idiopathic heart failure and/or arrhythmia of less than 3 months duration
  • Endomyocardial biopsy diagnostic of idiopathic giant cell myocarditis
  • Negative pregnancy test

Exclusion criteria:

  • Clinical evidence of sepsis or active infection (e.g., meningitis or osteomyelitis)
  • Pregnant
  • Any contraindication to immunosuppression
  • Allergy to cyclosporine or muromonab-CD3
  • Creatinine greater than 2.5 mg/dL
  • AST or ALT greater than 3 times upper limit of normal
  • Other severe concurrent disease that would preclude study
  • Unreliable or uncooperative subject

Information from the National Library of Medicine

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 identifier (NCT number): NCT00027443

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United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Leslie T Cooper, MD Mayo Clinic
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00027443    
Other Study ID Numbers: FD-R-1986-01
First Posted: December 7, 2001    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: October 2001
Keywords provided by FDA Office of Orphan Products Development:
Giant Cell Myocarditis
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors