Trial Outcomes & Findings for Conversion of CellCept to Myfortic: A Prospective Study in Liver Transplant Recipients (NCT NCT00336895)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

29 participants

Primary outcome timeframe

screening, 2, 6 and 12 weeks

Results posted on

2016-11-07

Participant Flow

30 participants were screened only 29 participants were enrolled

Participant milestones

Participant milestones
Measure	Liver Transplant Subjects All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days. Myfortic: Myfortic 360mg or 720 mg BID for 90 days.
Overall Study STARTED	30
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Liver Transplant Subjects All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days. Myfortic: Myfortic 360mg or 720 mg BID for 90 days.
Overall Study diarrhea	1
Overall Study nausea and upset stomach	1
Overall Study Physician Decision	1
Overall Study screen failed	1

Baseline Characteristics

Conversion of CellCept to Myfortic: A Prospective Study in Liver Transplant Recipients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liver Transplant Subjects n=29 Participants All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days. Myfortic: Myfortic 360mg or 720 mg BID for 90 days.
Age, Continuous	52.2 years STANDARD_DEVIATION 13.0 • n=93 Participants
Gender Female	13 Participants n=93 Participants
Gender Male	16 Participants n=93 Participants
Region of Enrollment United States	29 participants n=93 Participants
Abdominal Pain- screening	10.7778 units on a scale STANDARD_DEVIATION 5.09399 • n=93 Participants
Reflux screening	5.0000 units on a scale STANDARD_DEVIATION 3.67423 • n=93 Participants
Indigestion screening	12.6800 units on a scale STANDARD_DEVIATION 7.11056 • n=93 Participants
Diarrhea screening	10.3200 units on a scale STANDARD_DEVIATION 5.57315 • n=93 Participants
Constipation screening	7.2000 units on a scale STANDARD_DEVIATION 4.52769 • n=93 Participants

PRIMARY outcome

Timeframe: screening, 2, 6 and 12 weeks

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)

Outcome measures

Outcome measures
Measure	Liver Transplant Subjects n=29 Participants All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days. Myfortic: Myfortic 360mg or 720 mg BID for 90 days.
Gastrointestinal Side Effects and Quality of Life (Total Score of GSRS) screening	46.000 units on a scale Standard Deviation 21.17585
Gastrointestinal Side Effects and Quality of Life (Total Score of GSRS) 2 weeks	29.0400 units on a scale Standard Deviation 9.44934
Gastrointestinal Side Effects and Quality of Life (Total Score of GSRS) 6 weeks	26.2800 units on a scale Standard Deviation 8.79640
Gastrointestinal Side Effects and Quality of Life (Total Score of GSRS) 12 weeks	25.3600 units on a scale Standard Deviation 8.87356

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Liver Transplant Subjects n=29 Participants All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days. Myfortic: Myfortic 360mg or 720 mg BID for 90 days.
Number of Participants With Cytomegalovirus Infection or Disease	0 participants

PRIMARY outcome

Timeframe: 12 weeks

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.

Outcome measures

Outcome measures
Measure	Liver Transplant Subjects n=29 Participants All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days. Myfortic: Myfortic 360mg or 720 mg BID for 90 days.
Gastrointestinal Side Effects and Quality of Life (-Subscales of GSRS) Abdominal Pain	10.78 units on a scale Standard Deviation 5.09
Gastrointestinal Side Effects and Quality of Life (-Subscales of GSRS) Reflux	2.64 units on a scale Standard Deviation 1.04
Gastrointestinal Side Effects and Quality of Life (-Subscales of GSRS) Indigestion	7.08 units on a scale Standard Deviation 3.40
Gastrointestinal Side Effects and Quality of Life (-Subscales of GSRS) Diarrhea	5.44 units on a scale Standard Deviation 3.70
Gastrointestinal Side Effects and Quality of Life (-Subscales of GSRS) Constipation	4.56 units on a scale Standard Deviation 1.94

Adverse Events

Liver Transplant Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Roberto Lopez-Solis

UPittsburgh

Phone: 412-647-5173

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place