IRB Number:

147-99

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

The purpose of this research study is to determine if immunosuppressive treatment with an investigational drug called muromonab-CD3 can improve survival or decrease the need for heart transplantation in individuals with giant cell myocarditis. This study compares two different combinations of these drugs to evaluate the effectiveness and safety of this treatment. In this study,
muromonab-CD3, cyclosporine, and steroids will be compared with cyclosporine and steroids without muromonab-CD3.

Who is Eligible to Participate in the Study?

Men or women over the age of 18 who have been diagnosed with Giant Cell Myocarditis may be eligible to participate in this research study.

What is Involved With this Study?

Qualified participants will be randomly assigned (like the toss of a coin) to receive or not receive muromonab-CD3, in addition to usual care that included cyclosporine and a steroid. Both the doctor and the participant will know what drugs they are receiving.

Study participants will be given a steroid (dexamethasone or
methylprednisolone) once a day for 3 days through a catheter in the arm. After these doses, prednisone will be given by mouth once or twice per day. Cyclosporine will be given by mouth and the dose adjusted to achieve a target level in the blood. Participants assigned to receive muromonab-CD3, will receive it once a day for 10 days through a catheter in the arm.

How long will the Study run?

This research study lasts for one year. Most of the tests and studies performed during the year are part of the routine care of individuals with giant cell myocarditis; however participants will be required to have blood drawn six times during the study.

Who can I Contact for Additional Information on this Trial?

To participate or to obtain additional information please call (507) 284-3680.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 09/10/2004