Full Text View
Tabular View
No Study Results Posted
Related Studies
Measurement of Gastrointestinal (GI) and Health-Related Quality of Life (HRQL) Outcomes in Liver Transplant Recipients
This study has been completed.
First Received: November 27, 2006   Last Updated: June 12, 2009   History of Changes
Sponsored by: Novartis Pharmaceuticals
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00405652
  Purpose

Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will assess if a switch from MMF to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI and/or health-related quality of life in liver transplant recipients


Condition Intervention Phase
Liver Transplantation
Drug: Enteric-coated Mycophenolate sodium (EC-MPS)
Phase III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Measurement of Patient Reported Gastrointestinal (GI) and Health-Related Quality of Life (HRQL) Outcomes in Liver Transplant Recipients (MyLiver)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Changes in gastrointestinal symptom severity and health related quality of life [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Liver enzymes to determine the incidence of (subclinical) rejection episodes [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: January 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Enteric-coated Mycophenolate sodium (EC-MPS)
experimental

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria Patients who received liver transplant at least 3 month prior to study enrollment; who are stable on a current immunosuppressive regimen that includes a calcineurin or mTOR (tbd) inhibitor, steroids, and MMF at time of study enrollment; receiving MMF at a stable dose for at least 1 month prior to enrollment. with at least mild overall GI complications receiving drugs that may cause GI symptoms such as biphosphonates, minerals, vitamins, antibiotics or proton pump inhibitors (PPIs) have to be on a stable dose of these substances for at least 1 month prior to enrollment.

Exclusion criteria Patients with, GI symptoms assumed or known not to be caused by MPA therapy e.g. oral biphosphonates induced, infectious diarrhea); Acute rejection < 1 week prior to study enrollment; Patients with ALT, AST and / or bilirubin values 3x ULN. Patients with serum creatinine values 265 mol/l. Patients with hemoglobin values < 7g/dl and / or a absolute platelet count of < 50 x 109/l and / or a absolute leukocytes count of of < 2.0 x 109/l. Women of child-bearing potential who are planning to become pregnant or are pregnant and/or lactating or who are unwilling to use effective means of contraception; Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements; Undergoing acute medical intervention or hospitalization; Patients with hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolic mofetil or other components of the formulation

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00405652

Locations
Germany
Novartis Investigative Site
Nuernberg, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers: CERL080ADE09
Study First Received: November 27, 2006
Last Updated: June 12, 2009
ClinicalTrials.gov Identifier: NCT00405652     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Liver transplantation, mycophenolate, GI problems, Quality of Life

Study placed in the following topic categories:
Immunologic Factors
Mycophenolate mofetil
Mycophenolic Acid
Quality of Life
Immunosuppressive Agents

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs
Mycophenolate mofetil
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 03, 2009