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Sponsors and Collaborators: |
University of Pittsburgh Novartis |
Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00336895 |
The objective of this study is to determine the tolerability and safety of Myfortic in liver transplant patients. Patients receiving CellCept who have GI side effects will have CellCept discontinued and changed to Myfortic (Myfortic is a new drug similar to CellCept, except it is enteric-coated). Our hypothesis is that Myfortic has less GI side effects and will, therefore, be tolerated better than CellCept and also that Myfortic will have a comparable effectiveness to CellCept.
Condition | Intervention |
Immunosuppression |
Drug: Myfortic |
MedlinePlus related topics: | Liver Transplantation |
ChemIDplus related topics: | Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Mycophenolic acid |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Conversion of CellCept to Myfortic: A Prospective Study on the Tolerability and Safety of Myfortic in Liver Transplant Recipients |
Estimated Enrollment: | 30 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
This is a prospective, single center, open-label, safety and tolerability study on the use of Myfortic after liver transplantation. Adult liver transplant patients who are experiencing GI symptoms (nausea, vomiting, diarrhea, abdominal discomfort/pain, dyspepsia) attributable to CellCept are eligible to enter the study. CellCept will be discontinued and replaced with Myfortic. The duration of the study will be 3 months, and during this time, we will assess the incidence and severity of GI adverse events, the incidence and severity of bone marrow suppression (leukopenia), and the incidence of cytomegalovirus (CMV) infection or disease in patients receiving Myfortic.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael E de Vera, MD | 412-647-5174 | deverame@upmc.edu |
Contact: Laurie K Hope, RN | 412-692-2208 | hopelk@upmc.edu |
United States, Pennsylvania | |||||
University of Pittsburgh Medical Center | Recruiting | ||||
Pittsburgh, Pennsylvania, United States, 15213 | |||||
Contact: Michael E de Vera, MD 412-647-5174 deverame@upmc.edu | |||||
Contact: Laurie K Hope, RN 412-692-2208 hopelk@upmc.edu | |||||
Principal Investigator: Michael E de Vera, MD | |||||
Sub-Investigator: Amadeo Marcos, MD | |||||
Sub-Investigator: J. Wallis Marsh, MD` | |||||
Sub-Investigator: Paulo Fontes, MD | |||||
Sub-Investigator: Kusum Tom, MD | |||||
Sub-Investigator: Kyle Soltys, MD | |||||
Sub-Investigator: Ngoc Thai, MD | |||||
Sub-Investigator: Roberto Lopez, MD | |||||
Sub-Investigator: Deanna Blisard, MD | |||||
Sub-Investigator: Vinay Kumaran, MD | |||||
Sub-Investigator: Liise Kayler, MD | |||||
Sub-Investigator: Igor Dvorchik, MD | |||||
Sub-Investigator: Raman Venkataramanan, MD | |||||
Sub-Investigator: Barbara Yelochan, MD |
University of Pittsburgh |
Novartis |
Principal Investigator: | Michael E de Vera, MD | University of Pittsburgh |
Responsible Party: | UPMC ( Michael de Vera, M.D. ) |
Study ID Numbers: | CERL080A-US27 |
First Received: | June 12, 2006 |
Last Updated: | March 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00336895 |
Health Authority: | United States: Institutional Review Board |
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