Liver TransplantationPhase 4NCT00167492
Enteric Coated Myfortic for Liver Transplant Recipients
A Phase 4 study testing Myfortic in people with Liver Transplantation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to replace the mycophenolate mofetil (Cellcept) which is our usual therapy after liver transplantation with sodium mycophenolic acid (Myfortic®) and to find out the effect this change may have on the development of side effects such as relief of gastrointestinal (stomach) problems. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Myfortic
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Feb 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Liver transplant recipients
- Age: 18-70
- Capable of oral intake
Who cannot join
- Hepatitis C Cirrhosis
- Hepatocellular Carcinoma T3
- Liver retransplantation
- Pregnancy
- Platelet count <40,000
- White Blood Cell count (WBC) <3,000
- Incapable of oral intake
- More than 30 days post op
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enteric Coated Mycophenolic Acid (Myfortic) in Liver Transplant Recipients- Effect on Compliance and Calcineurin Inhibitor and Corticosteroid Sparing
The purpose of this study is to replace the mycophenolate mofetil (Cellcept) which is our usual therapy after liver transplantation with sodium mycophenolic acid (Myfortic®) and to find out the effect this change may have on the development of side effects such as relief of gastrointestinal (stomach) problems. In the past we have had to stop Cellcept (our current drug) because of these side effects. We will also try to see if improved usage of this drug (Myfortic®) will allow us to use lower doses of other medications that lower your immune system. We will do some special tests on your blood to see if the amount of the drug is related with its effect on the immune system and side effects. Both Cellcept and Myfortic® are FDA approved medications although Myfortic® is not approved for use after liver transplantation. Myfortic® is really the same active drug as Cellcept® (Mycophenolic acid) but has been coated to prevent breakdown of the drug in the stomach and is made to lower the known gastrointestinal effects of Cellcept such as diarrhea, abdominal pain and nausea.
Read the detailed description
Mycophenolic Acid (MPA) has been shown to be an effective immune suppressant in organ transplantation. Its gastrointestinal side effects, however, have limited its use in liver transplantation (OLT). A new form of MPA that is enteric coated (Myfortic) has been developed to address the issue of GI side effects. While considerable experience has been gained with this new formulation in kidney transplants (ref) the information regarding the use of Myfortic in OLT recipients is limited. The purpose of the study is to assess the safety and efficacy of Myfortic in OLT recipients. The study will include a close follow-up of the patients with regard to side effects and potential adverse effects of the drug. It will also monitor the rate of compliance with this medication among the patients in the study. The efficacy of the drug will be determined by the rate of rejection but also and more importantly by our ability to withdraw corticosteroids and minimize calcineurin inhibitors (CNI).
Several tests will be conducted as part of the study. Some of those are "Standard of Care" tests such as liver function tests and complete blood cell count (CBC). Some tests however, will be performed specifically for this study. These include a patient questionnaire to be filled at various time points and blood tests designed to assess the integrity of the immune system.
The benefit to the patients is three-fold:
The patients will receive the medication free of charge for the duration of the study.
The proven efficacy of MPA as an immune suppressant may allow us to reduce or eliminate the use of corticosteroids and/or CNI whose long and short-term side effects are major causes of morbidity in OLT recipients.
Avoidance of the GI side effects of non-enteric coated MPA, which is our standard drug in OLT.
The risks for the patient include the potential deleterious side effects of MPA, namely bone marrow depression, GI side-effects (nausea, diarrhea, abdominal pain), and infections.
The general benefits from the study may be the addition of a better formulation of MPA to the list of drugs used for immunosuppression in OLT. Additionally, routine use of this drug may minimize the long-term adverse effects of CNI and corticosteroids thus improving long-term patient survival and well-being.
- Conditions
- Liver Transplantation
- Being tested
- Myfortic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyforticDrug
720 mg by mouth every 12 hours
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of rejection
Measured: 6 months
Rate of gastrointestinal side-effects
Measured: 6 months
Secondary outcomes (3)
Levels of calcineurin inhibitors
Measured: 6 months
Renal function
Measured: 6 months
Relationship of dose to biologic monitoring of immunosuppression
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Investigators
- Bob Saggi, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167492
- Sponsor's protocol ID
- HSC-MS-05-0197
- Other IDs
- Novartis Pharmaceuticals, CERL080A-US11
- Status last verified
- Dec 2013
- First submitted
- 9 Sep 2005
- Last updated
- 9 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enteric Coated Mycophenolic Acid (Myfortic) in Liver Transplant Recipients- Effect on Compliance and Calcineurin Inhibitor and Corticosteroid Sparing
- ClinicalTrials.gov ID
- NCT00167492
- Acronym / sponsor ID
- HSC-MS-05-0197
- Conditions
- Liver Transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Sep 2005
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to replace the mycophenolate mofetil (Cellcept) which is our usual therapy after liver transplantation with sodium mycophenolic acid (Myfortic®) and to find out the effect this change may have on the development of side effects such as relief of gastrointestinal (stomach) problems. In the past we have had to stop Cellcept (our current drug) because of these side effects. We will also try to see if improved usage of this drug (Myfortic®) will allow us to use lower doses of other medications that lower your immune system. We will do some special tests on your blood to see if the amount of the drug is related with its effect on the immune system and side effects. Both Cellcept and Myfortic® are FDA approved medications although Myfortic® is not approved for use after liver transplantation. Myfortic® is really the same active drug as Cellcept® (Mycophenolic acid) but has been coated to prevent breakdown of the drug in the stomach and is made to lower the known gastrointestinal effects of Cellcept such as diarrhea, abdominal pain and nausea.
Detailed description
Mycophenolic Acid (MPA) has been shown to be an effective immune suppressant in organ transplantation. Its gastrointestinal side effects, however, have limited its use in liver transplantation (OLT). A new form of MPA that is enteric coated (Myfortic) has been developed to address the issue of GI side effects. While considerable experience has been gained with this new formulation in kidney transplants (ref) the information regarding the use of Myfortic in OLT recipients is limited. The purpose of the study is to assess the safety and efficacy of Myfortic in OLT recipients. The study will include a close follow-up of the patients with regard to side effects and potential adverse effects of the drug. It will also monitor the rate of compliance with this medication among the patients in the study. The efficacy of the drug will be determined by the rate of rejection but also and more importantly by our ability to withdraw corticosteroids and minimize calcineurin inhibitors (CNI).
Several tests will be conducted as part of the study. Some of those are "Standard of Care" tests such as liver function tests and complete blood cell count (CBC). Some tests however, will be performed specifically for this study. These include a patient questionnaire to be filled at various time points and blood tests designed to assess the integrity of the immune system.
The benefit to the patients is three-fold:
The patients will receive the medication free of charge for the duration of the study.
The proven efficacy of MPA as an immune suppressant may allow us to reduce or eliminate the use of corticosteroids and/or CNI whose long and short-term side effects are major causes of morbidity in OLT recipients.
Avoidance of the GI side effects of non-enteric coated MPA, which is our standard drug in OLT.
The risks for the patient include the potential deleterious side effects of MPA, namely bone marrow depression, GI side-effects (nausea, diarrhea, abdominal pain), and infections.
The general benefits from the study may be the addition of a better formulation of MPA to the list of drugs used for immunosuppression in OLT. Additionally, routine use of this drug may minimize the long-term adverse effects of CNI and corticosteroids thus improving long-term patient survival and well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Liver transplant recipients
- Age: 18-70
- Capable of oral intake
Key exclusion criteria (8 listed)
- Hepatitis C Cirrhosis
- Hepatocellular Carcinoma T3
- Liver retransplantation
- Pregnancy
- Platelet count <40,000
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 |
|---|---|---|
| Myfortic720 mg by mouth every 12 hours | Drug | – |
Primary outcome
Rate of rejection
Time frame: 6 months
Rate of gastrointestinal side-effects
Time frame: 6 months
3 secondary outcomes
Levels of calcineurin inhibitors
Time frame: 6 months
Renal function
Time frame: 6 months
Relationship of dose to biologic monitoring of immunosuppression
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2013.
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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.
Bob Saggi, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Myfortic in people with Liver Transplantation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 3 inclusion and 8 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: withdrawn, as of the sponsor's last update on 9 Dec 2013. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rate of rejection (time frame: 6 months). The study lists 2 primary outcomes in all. 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 9 Dec 2013; AzTrials last refreshed its copy on 7 Nov 2026.