NCT00027443

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2001

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

March 25, 2015

Status Verified

October 1, 2001

First QC Date

December 5, 2001

Last Update Submit

March 24, 2015

Conditions

Myocarditis

Keywords

Giant Cell Myocarditis

Interventions

Muromonab-CD3DRUG
CyclosporineDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Cooper LT Jr, Hare JM, Tazelaar HD, Edwards WD, Starling RC, Deng MC, Menon S, Mullen GM, Jaski B, Bailey KR, Cunningham MW, Dec GW; Giant Cell Myocarditis Treatment Trial Investigators. Usefulness of immunosuppression for giant cell myocarditis. Am J Cardiol. 2008 Dec 1;102(11):1535-9. doi: 10.1016/j.amjcard.2008.07.041. Epub 2008 Sep 18.

    PMID: 19026310DERIVED

MeSH Terms

Conditions

Myocarditis

Interventions

Muromonab-CD3Cyclosporine

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsImmunoglobulin GImmunoglobulin IsotypesSerum GlobulinsGlobulinsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptides

Study Officials

  • Leslie T Cooper, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 5, 2001

First Posted

December 7, 2001

Study Start

August 1, 2001

Study Completion

July 1, 2007

Last Updated

March 25, 2015

Record last verified: 2001-10

Locations

US(1)