Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-27 @ 9:31 PM
Study NCT ID:
NCT00336895
Status:
COMPLETED
Last Update Posted:
2016-11-07
First Post:
2006-06-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Conversion of CellCept to Myfortic: A Prospective Study in Liver Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009173', 'term': 'Mycophenolic Acid'}], 'ancestors': [{'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lopezrc@upmc.edu', 'phone': '412-647-5173', 'title': 'Dr. Roberto Lopez-Solis', 'organization': 'UPittsburgh'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '0-12 weeks', 'description': 'The protocol specified adverse events including bone marrow suppression, incidence of CMV infection and incidence of acute cellular rejection.', 'eventGroups': [{'id': 'EG000', 'title': 'Liver Transplant Subjects', 'description': 'All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.\n\nMyfortic: Myfortic 360mg or 720 mg BID for 90 days.', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Gastrointestinal Side Effects and Quality of Life (Total Score of GSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Liver Transplant Subjects', 'description': 'All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.\n\nMyfortic: Myfortic 360mg or 720 mg BID for 90 days.'}], 'classes': [{'title': 'screening', 'categories': [{'measurements': [{'value': '46.000', 'spread': '21.17585', 'groupId': 'OG000'}]}]}, {'title': '2 weeks', 'categories': [{'measurements': [{'value': '29.0400', 'spread': '9.44934', 'groupId': 'OG000'}]}]}, {'title': '6 weeks', 'categories': [{'measurements': [{'value': '26.2800', 'spread': '8.79640', 'groupId': 'OG000'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '25.3600', 'spread': '8.87356', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'screening, 2, 6 and 12 weeks', 'description': 'The gastrointestinal Symptom Rating Scale (GSRS) is a validated scale, the items range from 1= No discomfort at all to 7= Very severe discomfort.\n\nThe scale ranges from a minimal value of 15 ( No discomfort at all) to a maximum of 105 ( Very severe discomfort)\n\nThe 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)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Cytomegalovirus Infection or Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Liver Transplant Subjects', 'description': 'All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.\n\nMyfortic: Myfortic 360mg or 720 mg BID for 90 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Gastrointestinal Side Effects and Quality of Life (-Subscales of GSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Liver Transplant Subjects', 'description': 'All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.\n\nMyfortic: Myfortic 360mg or 720 mg BID for 90 days.'}], 'classes': [{'title': 'Abdominal Pain', 'categories': [{'measurements': [{'value': '10.78', 'spread': '5.09', 'groupId': 'OG000'}]}]}, {'title': 'Reflux', 'categories': [{'measurements': [{'value': '2.64', 'spread': '1.04', 'groupId': 'OG000'}]}]}, {'title': 'Indigestion', 'categories': [{'measurements': [{'value': '7.08', 'spread': '3.40', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '5.44', 'spread': '3.70', 'groupId': 'OG000'}]}]}, {'title': 'Constipation', 'categories': [{'measurements': [{'value': '4.56', 'spread': '1.94', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': '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.\n\nHigher values represent more severe discomfort.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Liver Transplant Subjects', 'description': 'All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.\n\nMyfortic: Myfortic 360mg or 720 mg BID for 90 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'diarrhea', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'nausea and upset stomach', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'screen failed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '30 participants were screened only 29 participants were enrolled'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Liver Transplant Subjects', 'description': 'All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.\n\nMyfortic: Myfortic 360mg or 720 mg BID for 90 days.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.2', 'spread': '13.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Abdominal Pain- screening', 'classes': [{'categories': [{'measurements': [{'value': '10.7778', 'spread': '5.09399', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The gastrointestinal Symptom Rating Scale (GSRS) is a validated scale, the items range from 1= No discomfort at all to 7= Very severe discomfort.\n\nThe scale ranges from a minimal value of 3 ( No discomfort at all) to a maximum of 21 ( Very severe discomfort)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Reflux screening', 'classes': [{'categories': [{'measurements': [{'value': '5.0000', 'spread': '3.67423', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The gastrointestinal Symptom Rating Scale (GSRS) is a validated scale, the items range from 1= No discomfort at all to 7= Very severe discomfort.\n\nThe scale ranges from a minimal value of 2 ( No discomfort at all) to a maximum of 14 ( Very severe discomfort)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Indigestion screening', 'classes': [{'categories': [{'measurements': [{'value': '12.6800', 'spread': '7.11056', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The gastrointestinal Symptom Rating Scale (GSRS) is a validated scale, the items range from 1= No discomfort at all to 7= Very severe discomfort.\n\nThe scale ranges from a minimal value of 4 ( No discomfort at all) to a maximum of 28 ( Very severe discomfort)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diarrhea screening', 'classes': [{'categories': [{'measurements': [{'value': '10.3200', 'spread': '5.57315', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The gastrointestinal Symptom Rating Scale (GSRS) is a validated scale, the items range from 1= No discomfort at all to 7= Very severe discomfort.\n\nThe scale ranges from a minimal value of 3 ( No discomfort at all) to a maximum of 21 ( Very severe discomfort)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Constipation screening', 'classes': [{'categories': [{'measurements': [{'value': '7.2000', 'spread': '4.52769', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The gastrointestinal Symptom Rating Scale (GSRS) is a validated scale, the items range from 1= No discomfort at all to 7= Very severe discomfort.\n\nThe scale ranges from a minimal value of 3 ( No discomfort at all) to a maximum of 21 ( Very severe discomfort)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': '30 potential participants were screened but only 29 enrolled.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-03', 'studyFirstSubmitDate': '2006-06-12', 'resultsFirstSubmitDate': '2016-05-19', 'studyFirstSubmitQcDate': '2006-06-12', 'lastUpdatePostDateStruct': {'date': '2016-11-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-03', 'studyFirstPostDateStruct': {'date': '2006-06-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastrointestinal Side Effects and Quality of Life (Total Score of GSRS)', 'timeFrame': 'screening, 2, 6 and 12 weeks', 'description': 'The gastrointestinal Symptom Rating Scale (GSRS) is a validated scale, the items range from 1= No discomfort at all to 7= Very severe discomfort.\n\nThe scale ranges from a minimal value of 15 ( No discomfort at all) to a maximum of 105 ( Very severe discomfort)\n\nThe 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)'}, {'measure': 'Number of Participants With Cytomegalovirus Infection or Disease', 'timeFrame': '12 weeks'}, {'measure': 'Gastrointestinal Side Effects and Quality of Life (-Subscales of GSRS)', 'timeFrame': '12 weeks', 'description': '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.\n\nHigher values represent more severe discomfort.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Liver transplantation', 'mycophenolate mofetil', 'gastrointestinal', 'adverse effects'], 'conditions': ['Immunosuppression']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ALL patients will be adult liver transplant recipients, males or females, 18-80 years of age\n* Patients currently receiving tacrolimus or cyclosporine with or without corticosteroids as part of their immunosuppressive regimen\n* Patients must be receiving CellCept and must have attributable G.I. symptoms (nausea, vomiting, diarrhea, abdominal discomfort/pain, dyspepsia)\n* Patients must be more than 30 days post-transplant to be eligible\n* Females of childbearing potential must have a negative serum pregnancy test prior to the inclusion period\n\nExclusion Criteria:\n\n* Multi-organ transplant patients\n* HIV positive patients.\n* Living-related liver transplant recipients\n* Pregnant patients\n* Patients with a history of extra-hepatic malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin\n* Patients with thrombocytopenia (\\<50,000/mm3), with an absolute neutrophil count of \\<1,000/mm3 and/or leukocytopenia (\\<2,000/mm3), and/or hemoglobin \\<7.0 g/dL prior to enrollment\n* Patients with a G.I. clinical problem at the time of enrollment (e.g. CMV infection or disease, C. difficile colitis, active peptic ulcer disease, gastroenteritis, inflammatory bowel disease)\n* Presence of clinically significant infection requiring continued therapy or uncontrolled diabetes mellitus\n* Evidence of drug and/or alcohol abuse\n* Decisionally impaired subjects who are not medically or mentally capable of providing consent themselves'}, 'identificationModule': {'nctId': 'NCT00336895', 'briefTitle': 'Conversion of CellCept to Myfortic: A Prospective Study in Liver Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Conversion of CellCept to Myfortic: A Prospective Study on the Tolerability and Safety of Myfortic in Liver Transplant Recipients', 'orgStudyIdInfo': {'id': 'CERL080A-US27'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liver Transplant Subjects', 'description': 'All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.', 'interventionNames': ['Drug: Myfortic']}], 'interventions': [{'name': 'Myfortic', 'type': 'DRUG', 'description': 'Myfortic 360mg or 720 mg BID for 90 days.', 'armGroupLabels': ['Liver Transplant Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Michael E de Vera, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Surgery', 'investigatorFullName': 'Roberto Lopez, MD', 'investigatorAffiliation': 'University of Pittsburgh'}}}}