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

NCT00336895 | Completed Results DMC

• 1 other identifier: CERL080A-US27
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunosuppression

Keywords

Liver transplantation; mycophenolate mofetil; gastrointestinal; adverse effects

Outcome Measures

Primary Outcomes (3)

• 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)

  screening, 2, 6 and 12 weeks

• Number of Participants With Cytomegalovirus Infection or Disease

  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.

  12 weeks

Study Arms (1)

Liver Transplant Subjects

EXPERIMENTAL

All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.

Drug: Myfortic

Interventions

Myfortic DRUG

Myfortic 360mg or 720 mg BID for 90 days.

Liver Transplant Subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ALL patients will be adult liver transplant recipients, males or females, 18-80 years of age
• Patients currently receiving tacrolimus or cyclosporine with or without corticosteroids as part of their immunosuppressive regimen
• Patients must be receiving CellCept and must have attributable G.I. symptoms (nausea, vomiting, diarrhea, abdominal discomfort/pain, dyspepsia)
• Patients must be more than 30 days post-transplant to be eligible

You may not qualify if:

• Multi-organ transplant patients
• HIV positive patients.
• Living-related liver transplant recipients
• Pregnant patients
• Patients with a history of extra-hepatic malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin
• 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
• 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)
• Presence of clinically significant infection requiring continued therapy or uncontrolled diabetes mellitus
• Evidence of drug and/or alcohol abuse
• Decisionally impaired subjects who are not medically or mentally capable of providing consent themselves

Sponsors & Collaborators

• University of Pittsburgh: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Results Point of Contact

• Title: Dr. Roberto Lopez-Solis
• Organization: UPittsburgh

lopezrc@upmc.edu

412-647-5173

Study Officials

• Michael E de Vera, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: June 12, 2006
• First Posted: June 14, 2006
• Study Start: November 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: November 7, 2016
• Results First Posted: November 7, 2016

Record last verified: 2016-11

Locations

US (1)