Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2001 by FDA Office of Orphan Products Development.
Recruitment status was  Recruiting
Information provided by:
FDA Office of Orphan Products Development Identifier:
First received: December 5, 2001
Last updated: June 23, 2005
Last verified: October 2001

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 Intervention
Drug: Muromonab-CD3
Drug: Cyclosporine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: Giant Cell Myocarditis Treatment Trial Pilot Study

Resource links provided by NLM:

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 40
Study Start Date: August 2001
Estimated Study Completion Date: July 2004
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.


Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00027443

United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Leslie T. Cooper, M.D.    507-284-3680   
Principal Investigator: Leslie T. Cooper, M.D.         
Sponsors and Collaborators
Principal Investigator: Leslie T Cooper, MD Mayo Clinic
  More Information

No publications provided by FDA Office of Orphan Products Development

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00027443     History of Changes
Other Study ID Numbers: FD-R-1986-01, FD-R-001986-0
Study First Received: December 5, 2001
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by FDA Office of Orphan Products Development:
Giant Cell Myocarditis

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Anti-Infective Agents
Antifungal Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on March 02, 2015