A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Heart Transplant Patients.
NCT ID: NCT02091414
Last Updated: 2014-10-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
36 participants
INTERVENTIONAL
2006-08-31
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MMF, CsA, Corticosteroids
Participants received mycophenolate mofetil (MMF) 1.0 grams (g), orally (PO), twice daily (BID) from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of cyclosporine A (CsA) 4 to 6 milligrams per kilogram (mg/kg) within 48 hours of transplantation, adjusted thereafter to a blood trough concentration of 150 to 300 nanograms per milliliter (ng/mL) through Week 24. Participants also received corticosteroids as per the practice of each participating center.
mycophenolate mofetil (MMF)
1.0 g PO BID
cyclosporine A (CsA)
Initial loading dose of 4 to 6 mg/kg within 48 hours of transplantation, adjusted thereafter to a blood trough concentration of 150 to 300 ng/mL
corticosteroids
As per the practice of each participating center
Interventions
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mycophenolate mofetil (MMF)
1.0 g PO BID
cyclosporine A (CsA)
Initial loading dose of 4 to 6 mg/kg within 48 hours of transplantation, adjusted thereafter to a blood trough concentration of 150 to 300 ng/mL
corticosteroids
As per the practice of each participating center
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patients receiving their first heart transplant (single organ transplant).
Exclusion Criteria
* patients with any antibody-treated acute rejection;
* known contraindications to treatment with sirolimus;
* history of malignancy, other than excised non-melanoma skin cancer which has not recurred for 2 years.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
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Beijing, , China
Fuzhou, , China
Shanghai, , China
Countries
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Other Identifiers
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ML20055
Identifier Type: -
Identifier Source: org_study_id
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