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

March 24, 2015 updated by: Mayo Clinic

Giant Cell Myocarditis Treatment Trial Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Leslie T Cooper, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Study Completion

July 1, 2007

Study Registration Dates

First Submitted

December 5, 2001

First Submitted That Met QC Criteria

December 6, 2001

First Posted (Estimate)

December 7, 2001

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

October 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FD-R-1986-01
  • FD-R-001986-0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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