Liver TransplantationPhase 3NCT00405652
Measurement of Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Liver Transplant Recipients
A Phase 3 study testing Enteric-coated Mycophenolate sodium (EC-MPS) in people with Liver Transplantation, run by Novartis Pharmaceuticals at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Enteric-coated Mycophenolate sodium (EC-MPS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2007to Sep 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measurement of Patient Reported Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Liver Transplant Recipients (MyLiver)
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
- Conditions
- Liver Transplantation
- Being tested
- Enteric-coated Mycophenolate sodium (EC-MPS)
- Keywords
- Liver transplantation, mycophenolate, GI problems, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteric-coated Mycophenolate sodium (EC-MPS)Drug
Also called myfortic
experimental
| Study group | Role | What they receive |
|---|---|---|
| Enteric-coated Mycophenolate sodium | Experimental | Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg. Receives: Drug: Enteric-coated Mycophenolate sodium (EC-MPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Gastrointestinal Symptom Severity and Health Related Quality of Life
Change in Gastrointestinal symptom rating scale (GSRS) total score from baseline visit to follow-up visit 6-8 weeks after treatment. The GSRS has 5 subscales (reflux, diarrhea, constipation, abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). The GSRS total score was computed by the mean of the subscale scores.
Measured: Baseline, End of Study (6-8 weeks)
Secondary outcomes (1)
The Number of Participants With Subclinical Rejection as Evaluated by a Change in Liver Enzymes
The number of participants with subclinical rejection episodes as defined by a steroid-sensitive, clinically relevant increase of AST, ALT, gamma-GT, AP or bilirubin (i.e., elevation of one or more of these enzymes that was considered clinically relevant and showed resolution upon treatment with a slight increase of steroid dosage).
Measured: 12-20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2006 (estimated)
- Study startJan 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405652
- Sponsor's protocol ID
- CERL080ADE09
- Status last verified
- Feb 2011
- First submitted
- 27 Nov 2006
- Last updated
- 3 Mar 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Patient Reported Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Liver Transplant Recipients (MyLiver)
- ClinicalTrials.gov ID
- NCT00405652
- Acronym / sponsor ID
- CERL080ADE09
- Conditions
- Liver Transplantation
- Keywords
- Liver transplantation, mycophenolate, GI problems, Quality of Life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 30 Nov 2006 (estimated)
- Results
- Posted 3 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enteric-coated Mycophenolate sodium | Experimental | Drug: Enteric-coated Mycophenolate sodium (EC-MPS)Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enteric-coated Mycophenolate sodium (EC-MPS)Also: myforticexperimental | Drug | Enteric-coated Mycophenolate sodium |
Primary outcome
Changes in Gastrointestinal Symptom Severity and Health Related Quality of Life
Time frame: Baseline, End of Study (6-8 weeks)
Change in Gastrointestinal symptom rating scale (GSRS) total score from baseline visit to follow-up visit 6-8 weeks after treatment. The GSRS has 5 subscales (reflux, diarrhea, constipation, abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). The GSRS total score was computed by the mean of the subscale scores.
1 secondary outcome
The Number of Participants With Subclinical Rejection as Evaluated by a Change in Liver Enzymes
Time frame: 12-20 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Enteric-coated Mycophenolate sodium (EC-MPS) in people with Liver Transplantation, run by Novartis Pharmaceuticals at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Gastrointestinal Symptom Severity and Health Related Quality of Life (time frame: Baseline, End of Study (6-8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2011; AzTrials last refreshed its copy on 8 Nov 2026.