MedDataX Logo

The Study to Evaluate Efficacy and Safety of MY-REPT Capsule in Primary, Liver Transplantation Recipients (MYLT1)

NCT ID: NCT01766518

Last Updated: 2013-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2014-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Efficacy and safety of MY-REPT capsule in primary, liver transplantation recipients

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Open label, Multicenter, Non-comparative Study to evaluate the efficacy and safety of MY-REPT capsule in primary, liver transplantation

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Evidence of Liver Transplantation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

liver transplantation LT Mycophenolate mofetil MMF

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MY-REPT capsule

MY-REPT capsule: Mycophenolate mofetil, 250mg/cap, orally

Group Type EXPERIMENTAL

Mycophenolate mofetil

Intervention Type DRUG

MY-REPT capsule 500\~1500mg/day, per oral, capsules twice a day with Tacrolimus, Corticosteroids, Basiliximab post liver transplantation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mycophenolate mofetil

MY-REPT capsule 500\~1500mg/day, per oral, capsules twice a day with Tacrolimus, Corticosteroids, Basiliximab post liver transplantation

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MY-REPT capsule

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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)
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

SungGyu Lee, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Asan medical center

Seoul, , South Korea

Site Status RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status COMPLETED

Seoul ST Mary's Hospital

Seoul, , South Korea

Site Status COMPLETED

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

SungGyu Lee, Ph.D

Role: CONTACT

Phone: +82 2 3010 7182

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

SungGyu Lee, Ph.D

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

m307LTP09D

Identifier Type: -

Identifier Source: org_study_id