Try our beta test site

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

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Roberto Lopez, MD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00336895
First received: June 12, 2006
Last updated: November 3, 2016
Last verified: November 2016
Results First Received: May 19, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Immunosuppression
Intervention: Drug: Myfortic

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
30 participants were screened only 29 participants were enrolled

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Liver Transplant Subjects
STARTED   30 
COMPLETED   26 
NOT COMPLETED   4 
diarrhea                1 
nausea and upset stomach                1 
Physician Decision                1 
screen failed                1 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
30 potential participants were screened but only 29 enrolled.

Reporting Groups
  Description
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.


Baseline Measures
   Liver Transplant Subjects 
Overall Participants Analyzed 
[Units: Participants]
 29 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.2  (13.0) 
Gender 
[Units: Participants]
Count of Participants
 
Female      13  44.8% 
Male      16  55.2% 
Region of Enrollment 
[Units: Participants]
 
United States   29 
Abdominal Pain- screening [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 10.7778  (5.09399) 
[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 3 ( No discomfort at all) to a maximum of 21 ( Very severe discomfort)

Reflux screening [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 5.0000  (3.67423) 
[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 2 ( No discomfort at all) to a maximum of 14 ( Very severe discomfort)

Indigestion screening [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 12.6800  (7.11056) 
[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 4 ( No discomfort at all) to a maximum of 28 ( Very severe discomfort)

Diarrhea screening [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 10.3200  (5.57315) 
[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 3 ( No discomfort at all) to a maximum of 21 ( Very severe discomfort)

Constipation screening [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 7.2000  (4.52769) 
[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 3 ( No discomfort at all) to a maximum of 21 ( Very severe discomfort)



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Gastrointestinal Side Effects and Quality of Life (Total Score of GSRS)   [ Time Frame: screening, 2, 6 and 12 weeks ]

2.  Primary:   Number of Participants With Cytomegalovirus Infection or Disease   [ Time Frame: 12 weeks ]

3.  Primary:   Gastrointestinal Side Effects and Quality of Life (-Subscales of GSRS)   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Roberto Lopez-Solis
Organization: UPittsburgh
phone: 412-647-5173
e-mail: lopezrc@upmc.edu



Responsible Party: Roberto Lopez, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00336895     History of Changes
Other Study ID Numbers: CERL080A-US27
Study First Received: June 12, 2006
Results First Received: May 19, 2016
Last Updated: November 3, 2016