Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336895
Status:
COMPLETED
Last Update Posted:
2016-11-06
First Post:
2006-06-12
Brief Title:
Conversion of CellCept to Myfortic A Prospective Study in Liver Transplant Recipients
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Conversion of CellCept to Myfortic A Prospective Study on the Tolerability and Safety of Myfortic in Liver Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 discomfortpain 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None