Evidence of Liver TransplantationPhase 4NCT01766518
The Study to Evaluate Efficacy and Safety of MY-REPT Capsule in Primary, Liver Transplantation Recipients (MYLT1)
A Phase 4 study testing Mycophenolate mofetil in people with Evidence of Liver Transplantation, run by Chong Kun Dang Pharmaceutical at 3 sites in South Korea.
Trial summary
Efficacy and safety of MY-REPT capsule in primary, liver transplantation recipients Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Evidence of Liver Transplantation
- What is being tested?
- Mycophenolate mofetil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Nov 2009to May 2014
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with primary liver transplantation recipients
- Male and Female aged ≥19 and ≤65
- Patient with ABO blood type correspond with Donor's blood type
- Patient who agreement with written informed consent
- Patient who Women if had childbearing potential must have a negative serum or urine pregnancy test at the screening visit and agreement with contraception
Who cannot join
- Patient with secondary liver transplantation(LT) recipient or other organ transplantation recipient in past or current
- Patient with multi-organ transplantation recipient
- Patient with dual-graft transplantation recipient
- Patient who used body artificial liver before LT
- Cr level >2.0mg/dL in screening
- WBC <2,000/mm3 or ANC <900/mm3 or PLT <30,000/mm3 in screening
Show all 11Show fewer
- Patient who experienced severe gastrointestinal disorder so investigator judge the man's participation impossible
- Patient who experienced severe infection (need to treatment)
- Patient or Donor with HIV positive
- Patient who need to treat with immunosuppressant or chemistry therapy
- Patient who had taken immunosuppressant within 30days before LT (except to take Corticosteroids and Tacrolimus due to protocol)
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 1 recruiting
- Recruiting
Asan medical center
Seoul
SungGyu Lee, Ph.D, +82 2 3010 7182, sglee2@amc.ac.kr
SungGyu Lee, Ph.D
- Completed
Samsung Medical Center
Seoul
- Completed
Seoul ST Mary's Hospital
Seoul
About this study
Official title: Open Label, Multicenter, Non-comparative Study to Evaluate the Efficacy and Safety of MY-REPT Capsule in Primary, Liver Transplantation Recipients.
Efficacy and safety of MY-REPT capsule in primary, liver transplantation recipients
Read the detailed description
Open label, Multicenter, Non-comparative Study to evaluate the efficacy and safety of MY-REPT capsule in primary, liver transplantation
- Conditions
- Evidence of Liver Transplantation
- Being tested
- Mycophenolate mofetil
- Keywords
- liver transplantation, LT, Mycophenolate mofetil, MMF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called MY-REPT capsule
MY-REPT capsule 500~1500mg/day, per oral, capsules twice a day with Tacrolimus, Corticosteroids, Basiliximab post liver transplantation
| Study group | Role | What they receive |
|---|---|---|
| MY-REPT capsule | Experimental | MY-REPT capsule: Mycophenolate mofetil, 250mg/cap, orally Receives: Drug: Mycophenolate mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of acute rejection
Rate acute rejection by liver biopsy
Measured: up to 26weeks
Secondary outcomes (5)
Frequency, Time, Severity of acute rejection
Measured: up to 26 weeks
Graft loss, Patient survival rate
Measured: up to 26weeks
Kidney function test by e-GFR(Glomerular filtration rate)
Measured: up to 26weeks
Questionnaire of gastrointestinal symptom assessment
Measured: screening visit, closing visit
Questionnaire of gastrointestinal quality of life index
Measured: screening visit, closing visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startNov 2009
- Primary completionApr 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evidence of Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SungGyu Lee, Ph.D, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766518
- Sponsor's protocol ID
- m307LTP09D
- Status last verified
- Nov 2013
- First submitted
- 10 Jan 2013
- Last updated
- 7 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Multicenter, Non-comparative Study to Evaluate the Efficacy and Safety of MY-REPT Capsule in Primary, Liver Transplantation Recipients.
- ClinicalTrials.gov ID
- NCT01766518
- Acronym / sponsor ID
- m307LTP09D
- Conditions
- Evidence of Liver Transplantation
- Keywords
- liver transplantation, LT, Mycophenolate mofetil, MMF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Apr 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 11 Jan 2013 (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.
Efficacy and safety of MY-REPT capsule in primary, liver transplantation recipients
Detailed description
Open label, Multicenter, Non-comparative Study to evaluate the efficacy and safety of MY-REPT capsule in primary, liver transplantation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MY-REPT capsule | Experimental | Drug: Mycophenolate mofetilMY-REPT capsule: Mycophenolate mofetil, 250mg/cap, orally |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with primary liver transplantation recipients
- Male and Female aged ≥19 and ≤65
- Patient with ABO blood type correspond with Donor's blood type
- Patient who agreement with written informed consent
- Patient who Women if had childbearing potential must have a negative serum or urine pregnancy test at the screening visit and agreement with contraception
Key exclusion criteria (11 listed)
- Patient with secondary liver transplantation(LT) recipient or other organ transplantation recipient in past or current
- Patient with multi-organ transplantation recipient
- Patient with dual-graft transplantation recipient
- Patient who used body artificial liver before LT
- Cr level >2.0mg/dL in screening
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 |
|---|---|---|
| Mycophenolate mofetilAlso: MY-REPT capsuleMY-REPT capsule 500~1500mg/day, per oral, capsules twice a day with Tacrolimus, Corticosteroids, Basiliximab post liver transplantation | Drug | MY-REPT capsule |
Primary outcome
Rate of acute rejection
Time frame: up to 26weeks
Rate acute rejection by liver biopsy
5 secondary outcomes
Frequency, Time, Severity of acute rejection
Time frame: up to 26 weeks
Graft loss, Patient survival rate
Time frame: up to 26weeks
Kidney function test by e-GFR(Glomerular filtration rate)
Time frame: up to 26weeks
Questionnaire of gastrointestinal symptom assessment
Time frame: screening visit, closing visit
Questionnaire of gastrointestinal quality of life index
Time frame: screening visit, closing visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2013.
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.
SungGyu Lee, Ph.D principal investigator
Asan Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mycophenolate mofetil in people with Evidence of Liver Transplantation, run by Chong Kun Dang Pharmaceutical at 3 sites in South Korea.
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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 7 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SungGyu Lee, Ph.D (+82 2 3010 7182, sglee2@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of acute rejection (time frame: up to 26weeks). 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 7 Nov 2013.