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Sponsors and Collaborators: |
The University of North Carolina, Chapel Hill Novartis Pharmaceuticals |
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Information provided by: | The University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00619216 |
Liver transplant patients often require multimodal immunosuppressive therapy to minimize their risk for rejection. In our regimen, MMF (mycophenolate mofetil) is often added to lower the side effects of the calcineurin inhibitors. Unfortunately the literature reports 20% up to as many as 40% of patients have GI intolerance to MMF. At our Center, approximately 30% of patients have intolerance to MMF, thereby mitigating our ability to use this agent. The primary objective of this study is to assess the tolerability of myfortic in combination with Neoral or Tacrolimus as determined by the GSRS (Gastrointestinal Symptom Rating Scale) after conversion from MMF in maintenance liver transplant patients with GI intolerance within 3 months.
Condition | Intervention |
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GI Disturbance |
Drug: Mycophenolic Acid (Myfortic) |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | A Three-Month, Open-Label, Two Cohort Study to Investigate the Safety and Tolerability of Myfortic in Combination With Neoral (Cyclosporin) or Prograf (Tacrolimus) in Liver Transplant Recipients With GI Intolerance |
Estimated Enrollment: | 30 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Valorie Buchholz, RN | 919-966-8227 | buchholz@med.unc.edu |
United States, North Carolina | |
University of North Carolina-Chapel Hill | Recruiting |
Chapel Hill, North Carolina, United States, 27599-7211 |
Principal Investigator: | David Gerber, MD | UNC-Chapel Hill Department of Surgery |
Responsible Party: | UNC Department of Surgery ( David Gerber, MD/Principal Investigator ) |
Study ID Numbers: | 07-1203 |
Study First Received: | February 7, 2008 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00619216 |
Health Authority: | United States: Institutional Review Board |
Orthotopic Liver Transplant Recipients with GI disturbance |
Cyclosporine Mycophenolate mofetil Mycophenolic Acid Tacrolimus Cyclosporins |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Enzyme Inhibitors Antibiotics, Antineoplastic Pharmacologic Actions |