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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00048165
First received: October 24, 2002
Last updated: December 15, 2005
Last verified: December 2005
History of Changes
  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 4

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Daclizumab
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

  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

No publications provided

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

Additional relevant MeSH terms:
Daclizumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013