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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00027443
First Posted: December 7, 2001
Last Update Posted: March 25, 2015
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.
Information provided by:
FDA Office of Orphan Products Development
  Purpose
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
Myocarditis Drug: Muromonab-CD3 Drug: Cyclosporine

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: None (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 2007
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
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 ClinicalTrials.gov identifier (NCT number): NCT00027443


Locations
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Leslie T Cooper, MD Mayo Clinic
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00027443     History of Changes
Other Study ID Numbers: FD-R-1986-01
FD-R-001986-0
First Submitted: December 5, 2001
First Posted: December 7, 2001
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:
Myocarditis
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Cyclosporins
Cyclosporine
Muromonab-CD3
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


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