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Sponsored by: |
Novartis Pharmaceuticals |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00405652 |
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will assess if a switch from MMF to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI and/or health-related quality of life in liver transplant recipients
Condition | Intervention | Phase |
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Liver Transplantation |
Drug: Enteric-coated Mycophenolate sodium (EC-MPS) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Measurement of Patient Reported Gastrointestinal (GI) and Health-Related Quality of Life (HRQL) Outcomes in Liver Transplant Recipients (MyLiver) |
Enrollment: | 34 |
Study Start Date: | January 2007 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Enteric-coated Mycophenolate sodium (EC-MPS)
experimental
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria Patients who received liver transplant at least 3 month prior to study enrollment; who are stable on a current immunosuppressive regimen that includes a calcineurin or mTOR (tbd) inhibitor, steroids, and MMF at time of study enrollment; receiving MMF at a stable dose for at least 1 month prior to enrollment. with at least mild overall GI complications receiving drugs that may cause GI symptoms such as biphosphonates, minerals, vitamins, antibiotics or proton pump inhibitors (PPIs) have to be on a stable dose of these substances for at least 1 month prior to enrollment.
Exclusion criteria Patients with, GI symptoms assumed or known not to be caused by MPA therapy e.g. oral biphosphonates induced, infectious diarrhea); Acute rejection < 1 week prior to study enrollment; Patients with ALT, AST and / or bilirubin values 3x ULN. Patients with serum creatinine values 265 mol/l. Patients with hemoglobin values < 7g/dl and / or a absolute platelet count of < 50 x 109/l and / or a absolute leukocytes count of of < 2.0 x 109/l. Women of child-bearing potential who are planning to become pregnant or are pregnant and/or lactating or who are unwilling to use effective means of contraception; Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements; Undergoing acute medical intervention or hospitalization; Patients with hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolic mofetil or other components of the formulation
Other protocol-defined inclusion/exclusion criteria may apply
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CERL080ADE09 |
Study First Received: | November 27, 2006 |
Last Updated: | June 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00405652 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Liver transplantation, mycophenolate, GI problems, Quality of Life |
Immunologic Factors Mycophenolate mofetil Mycophenolic Acid Quality of Life Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Mycophenolate mofetil Immunosuppressive Agents Pharmacologic Actions |