GI DisturbanceNCT00619216
Myfortic Conversion Trial in OLT Recipients With GI Intolerance
An observational study of GI Disturbance, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Liver transplant patients often require multimodal immunosuppressive therapy to minimize their risk for rejection. In our regimen, MMF (mycophenolate mofetil) is often added to lower the side effects of the calcineurin inhibitors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- GI Disturbance
- What is being tested?
- Mycophenolic Acid (Myfortic)
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Dec 2009
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Recipients of Orthotopic Liver Transplants
Who may be able to join
- Recipients of orthotopic liver transplant at least 8 weeks post transplant
- Mild and/or moderate GI complaints directly related to MMF
Who cannot join
- Multi-organ transplant recipients
- Evidence of graft rejection within 14 days prior to Baseline visit
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, 27599-7211
About this study
Official title: A Three-Month, Open-Label, Two Cohort Study to Investigate the Safety and Tolerability of Myfortic in Combination With Neoral (Cyclosporin) or Prograf (Tacrolimus) in Liver Transplant Recipients With GI Intolerance
Liver transplant patients often require multimodal immunosuppressive therapy to minimize their risk for rejection. In our regimen, MMF (mycophenolate mofetil) is often added to lower the side effects of the calcineurin inhibitors. Unfortunately the literature reports 20% up to as many as 40% of patients have GI intolerance to MMF. At our Center, approximately 30% of patients have intolerance to MMF, thereby mitigating our ability to use this agent. The primary objective of this study is to assess the tolerability of myfortic in combination with Neoral or Tacrolimus as determined by the GSRS (Gastrointestinal Symptom Rating Scale) after conversion from MMF in maintenance liver transplant patients with GI intolerance within 3 months.
- Conditions
- GI Disturbance
- Being tested
- Mycophenolic Acid (Myfortic)
- Keywords
- Orthotopic Liver Transplant Recipients with GI disturbance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycophenolic Acid (Myfortic)Drug
Also called Cellcept; Myfortic
Equimolar conversion from mycophenolate mofetil to mycophenolic acid
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of GI symptoms using GSRS, GIQLi, and SF-12 after conversion to Myfortic
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GI DisturbanceStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Investigators
- David Gerber, MD, Principal investigator, UNC-Chapel Hill Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619216
- Sponsor's protocol ID
- 07-1203
- Status last verified
- Jun 2011
- First submitted
- 7 Feb 2008
- Last updated
- 3 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-Month, Open-Label, Two Cohort Study to Investigate the Safety and Tolerability of Myfortic in Combination With Neoral (Cyclosporin) or Prograf (Tacrolimus) in Liver Transplant Recipients With GI Intolerance
- ClinicalTrials.gov ID
- NCT00619216
- Acronym / sponsor ID
- 07-1203
- Conditions
- GI Disturbance
- Keywords
- Orthotopic Liver Transplant Recipients with GI disturbance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Mar 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 20 Feb 2008 (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.
Liver transplant patients often require multimodal immunosuppressive therapy to minimize their risk for rejection. In our regimen, MMF (mycophenolate mofetil) is often added to lower the side effects of the calcineurin inhibitors. Unfortunately the literature reports 20% up to as many as 40% of patients have GI intolerance to MMF. At our Center, approximately 30% of patients have intolerance to MMF, thereby mitigating our ability to use this agent. The primary objective of this study is to assess the tolerability of myfortic in combination with Neoral or Tacrolimus as determined by the GSRS (Gastrointestinal Symptom Rating Scale) after conversion from MMF in maintenance liver transplant patients with GI intolerance within 3 months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recipients of Orthotopic Liver Transplants
Key inclusion criteria (2 listed)
- Recipients of orthotopic liver transplant at least 8 weeks post transplant
- Mild and/or moderate GI complaints directly related to MMF
Key exclusion criteria (2 listed)
- Multi-organ transplant recipients
- Evidence of graft rejection within 14 days prior to Baseline visit
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 |
|---|---|---|
| Mycophenolic Acid (Myfortic)Also: Cellcept; MyforticEquimolar conversion from mycophenolate mofetil to mycophenolic acid | Drug | – |
Primary outcome
Evaluation of GI symptoms using GSRS, GIQLi, and SF-12 after conversion to Myfortic
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2011.
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.
David Gerber, MD principal investigator
UNC-Chapel Hill Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GI Disturbance, run by University of North Carolina, Chapel Hill 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 2 inclusion and 2 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 Jun 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 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of GI symptoms using GSRS, GIQLi, and SF-12 after conversion to Myfortic (time frame: 3 months). 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 Jun 2011.