Myfortic Conversion Trial in OLT Recipients With GI Intolerance
This study has been completed.
Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
Novartis Pharmaceuticals
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00619216
First received: February 7, 2008
Last updated: June 1, 2011
Last verified: June 2011
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 7, 2008 | ||||
| Last Updated Date | June 1, 2011 | ||||
| Start Date ICMJE | March 2008 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Evaluation of GI symptoms using GSRS, GIQLi, and SF-12 after conversion to Myfortic [ Time Frame: 3 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00619216 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Myfortic Conversion Trial in OLT Recipients With GI Intolerance | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Recipients of Orthotopic Liver Transplants |
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| Condition ICMJE | GI Disturbance | ||||
| Intervention ICMJE | Drug: Mycophenolic Acid (Myfortic)
Equimolar conversion from mycophenolate mofetil to mycophenolic acid
Other Name: Cellcept; Myfortic |
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| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 31 | ||||
| Completion Date | December 2009 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00619216 | ||||
| Other Study ID Numbers ICMJE | 07-1203 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | David Gerber, MD/Principal Investigator, UNC Department of Surgery | ||||
| Study Sponsor ICMJE | University of North Carolina, Chapel Hill | ||||
| Collaborators ICMJE | Novartis Pharmaceuticals | ||||
| Investigators ICMJE |
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| Information Provided By | University of North Carolina, Chapel Hill | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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