Efficacy Study of Zenapax in Combination With CellCept, Cyclosporine and Corticosteroids in Heart Transplant

This study has been completed.

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00048165

Purpose

The purpose of this study is to determine whether the combination of Zenapax, CellCept, Cyclosporine and Corticosteroids are effective in patients receiving heart transplants.

Condition	Intervention	Phase
Transplantation	Drug: ZENAPAX	Phase IV

MedlinePlus related topics: Heart Transplantation

Drug Information available for: Cyclosporin Cyclosporine Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Corticosteroids Dacliximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Undergoing heart transplant
Males or females who are 13 years or older
Women of childbearing potential must have a negative pregnancy test
Must be able to swallow tablets
Must be able to understand and comply with the study

Exclusion Criteria:

Previous transplants
Patients receiving multiple organs
HIV or Hepatitis
Patients with certain blood disorders
Patients who are taking certain experimental medicines
Women who are lactating or pregnant or who are unwilling to use two reliable forms of contraception
Severe diarrhea or other stomach problems
Cancer within the past 5 years (except for skin cancer that is treated)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048165

Show 36 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

More Information

Study ID Numbers:	NR15880
Study First Received:	October 24, 2002
Last Updated:	December 15, 2005
ClinicalTrials.gov Identifier:	NCT00048165
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Cyclosporine
Daclizumab
Mycophenolate mofetil
Cyclosporins

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009