An interventional study of Myfortic in Immunosuppression, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-11-06.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
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.
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.
University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.
Drug: Myfortic
Myfortic 360mg or 720 mg BID for 90 days.
Gastrointestinal Side Effects and Quality of Life (Total Score of GSRS)
The gastrointestinal Symptom Rating Scale (GSRS) is a validated scale, the items range from 1= No discomfort at all to 7= Very severe discomfort. The scale ranges from a minimal value of 15 ( No discomfort at all) to a maximum of 105 ( Very severe discomfort) The GSRS contains 15 items, each rated on a seven- point likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items breakdown into the following five scales: abdominal ( Abdominal pain, hunger pains and nausea): reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome ( borborygmus, abdominal distention, eructation and increased flatus) and constipation syndrome (constipation, hard stools and feeling of incomplete evacuation)
Time frame: screening, 2, 6 and 12 weeks
Number of Participants With Cytomegalovirus Infection or Disease
Time frame: 12 weeks
Gastrointestinal Side Effects and Quality of Life (-Subscales of GSRS)
The GSRS contains 15 items, each rated on a seven- point likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items breakdown into the following five scales: abdominal ( Abdominal pain, hunger pains and nausea): reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome ( borborygmus, abdominal distention, eructation and increased flatus) and constipation syndrome (constipation, hard stools and feeling of incomplete evacuation) The range of the scale for abdominal pain was 3 to 21, reflux 2 to 14, diarrhea 3 to 21, indigestion 4 to 28 and constipation 3 to 21. Higher values represent more severe discomfort.
Time frame: 12 weeks
| Milestone | Liver Transplant Subjects |
|---|---|
| Started | 30 |
| Completed | 26 |
| Not completed | 4 |
| Withdrew: Diarrhea | 1 |
| Withdrew: Nausea and upset stomach | 1 |
| Withdrew: Physician decision | 1 |
| Withdrew: Screen failed | 1 |
The gastrointestinal Symptom Rating Scale (GSRS) is a validated scale, the items range from 1= No discomfort at all to 7= Very severe discomfort. The scale ranges from a minimal value of 15 ( No discomfort at all) to a maximum of 105 ( Very severe discomfort) The GSRS contains 15 items, each rated on a seven- point likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items breakdown into the following five scales: abdominal ( Abdominal pain, hunger pains and nausea): reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome ( borborygmus, abdominal distention, eructation and increased flatus) and constipation syndrome (constipation, hard stools and feeling of incomplete evacuation)
| units on a scale | Liver Transplant Subjects |
|---|---|
| screening | 46.000 ± 21.17585 |
| 2 weeks | 29.0400 ± 9.44934 |
| 6 weeks | 26.2800 ± 8.79640 |
| 12 weeks | 25.3600 ± 8.87356 |
| participants | Liver Transplant Subjects |
|---|---|
| Number of Participants With Cytomegalovirus Infection or Disease | 0 |
The GSRS contains 15 items, each rated on a seven- point likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items breakdown into the following five scales: abdominal ( Abdominal pain, hunger pains and nausea): reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome ( borborygmus, abdominal distention, eructation and increased flatus) and constipation syndrome (constipation, hard stools and feeling of incomplete evacuation) The range of the scale for abdominal pain was 3 to 21, reflux 2 to 14, diarrhea 3 to 21, indigestion 4 to 28 and constipation 3 to 21. Higher values represent more severe discomfort.
| units on a scale | Liver Transplant Subjects |
|---|---|
| Abdominal Pain | 10.78 ± 5.09 |
| Reflux | 2.64 ± 1.04 |
| Indigestion | 7.08 ± 3.40 |
| Diarrhea | 5.44 ± 3.70 |
| Constipation | 4.56 ± 1.94 |
Collected over 0-12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Liver Transplant Subjects | — | 0/30 (0%) | 0/30 (0%) |
30 potential participants were screened but only 29 enrolled.
| Age, Continuous(years) | Liver Transplant Subjects |
|---|---|
| Mean | 52.2 ± 13.0 |
| Gender(Participants) | Liver Transplant Subjects |
|---|---|
| Female | 13 |
| Male | 16 |
| Region of Enrollment(participants) | Liver Transplant Subjects |
|---|---|
| United States | 29 |
| Abdominal Pain- screening(units on a scale) | Liver Transplant Subjects |
|---|---|
| Mean | 10.7778 ± 5.09399 |
| Reflux screening(units on a scale) | Liver Transplant Subjects |
|---|---|
| Mean | 5.0000 ± 3.67423 |
| Indigestion screening(units on a scale) | Liver Transplant Subjects |
|---|---|
| Mean | 12.6800 ± 7.11056 |
| Diarrhea screening(units on a scale) | Liver Transplant Subjects |
|---|---|
| Mean | 10.3200 ± 5.57315 |
| Constipation screening(units on a scale) | Liver Transplant Subjects |
|---|---|
| Mean | 7.2000 ± 4.52769 |
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Pittsburgh