Measurement of Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Liver Transplant Recipients
Condition: Liver Transplantation
Intervention: Enteric-coated Mycophenolate sodium (EC-MPS)
Intervention description: experimental
Intervention MeSH terms: Mycophenolic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Liver transplantation, mycophenolate, GI problems, Quality of Life

Summary:

      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
    

Eligibility criteria:

        Inclusion Criteria:

          -  Received liver transplant at least 3 months prior to study enrollment.

          -  Receiving immunosuppressive regimen that includes a calcineurin or mTOR inhibitor, and
             MMF at time of study enrolment. The patient must be stable on current
             immunosuppressive regimen. The MMF dose must be stable for at least 1 month prior to
             enrollment. Steroid use will be according to local practice.

          -  Patients can only be enrolled into the study if it is expected that treatment will
             continue at the same dose until study end (6-8 weeks after enrollment).

          -  Patients with a medical condition that necessitates MPA-treatment for probably the
             next 6- 8 weeks (time of study duration).

          -  Patients with at least mild overall Gastrointestinal (G)I complications as assessed by
             the GI complications Case Report Form(CRF).

          -  Eligible and willing to convert to Myfortic.

          -  At lease 18 years of age.

          -  Willing to provide written informed consent.

          -  Able to meet all study requirements including completing the questionnaires and
             completing 2 study visits.

          -  Patients receiving drugs that may cause GI symptoms such as bisphosphonates, 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. Patients receiving these
             drugs can only be enrolled into the study, if it is expected that treatment will
             continue at the same dose until study end (6-8 weeks after enrollment).

          -  Females capable of becoming pregnant must have a negative pregnancy test within 7 days
             prior to or at baseline. Pregnancy test has to be repeated every 4 weeks. Females are
             required to practice an approved method of birth control for the duration of the study
             and for a period of 6 weeks following discontinuation of study medication, even where
             there has been a history of infertility.

        Exclusion criteria:

          -  If applicable, GI symptoms assumed or know not to be caused by MPA therapy (e.g. oral
             bisphosphonates induced, infections diarrhea).

          -  Acute rejection <1 week prior to study enrollment

          -  Patients with Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) and or/
             bilirubin values >=3 x Upper limit normal (ULN) (values available from the last
             routine assessment within 3 months are acceptable).

          -  Patients with serum creatinine values >=265 umol/L (values available from the last
             routine assessment within 3 month are acceptable).

          -  Patients with hemoglobin values <7g/dL and/or an absolute platelet count of <50 x
             10^9/L and /or an absolute leukocytes count of <2.0 x10^9/L (values available from the
             last routine assessment within 3 month are acceptable.)

          -  Woman of child-bearing potential who is planning to become pregnant or is pregnant
             and/or lactating or who is unwilling to use effective means of contraception.

          -  Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the
             opinion of the site investigator, could interfere with study requirements.

          -  Undergoing acute medical intervention or hospitalization.

          -  Presence of a medical condition not related to a GI event at the time of visit, which
             requires immediate medical intervention.

          -  Any other medical condition that, in the opinion of the site investigator based on
             recall or chart review, interfere with completing the study, including but not limited
             to, visual problems or cognitive impairment.

          -  Receiving any investigational drug or have received any investigational drug within 30
             days prior to study enrollment.

          -  Patients with hypersensitivity to mycophenolate sodium, mycophenolic acid,
             mycophenolic mofetil or other components of the formulation (e.g. lactose; see also
             SmPCs)

        Other protocol-defined inclusion/exclusion criteria may apply.