Efficacy and Safety of CertiroBell® Tablet Plus Tacrolimu... | NCT04867720

Studies
Efficacy and Safety of CertiroBell® Tablet Plus Tacrolimus in Primary Living Donor Liver Transplant Recipients

NCT04867720

Sponsor

Chong Kun Dang Pharmaceutical

Status

Unknown status

Last Update Posted

Apr 30, 2021Actual

Enrollment

112Estimated

Phase

Phase 4

Conditions

Liver Transplant

Interventions

Everolimus

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 16, 2021Actual

Primary Completion Date

Oct 10, 2022Estimated

Completion Date

Feb 22, 2023Estimated

First Submitted Date

Apr 29, 2021

First Submission Date that Met QC Criteria

Apr 29, 2021

First Posted Date

Apr 30, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2021

Last Update Posted Date

Apr 30, 2021Actual

Label	Type	Description	Intervention Names
CertiroBell Tablet	Experimental	Use in combination with Tacrolimus at least 6 months after liver transplantation.	Drug: Everolimus

Name	Type	Description	Arm Group Labels	Other Names
Everolimus	Drug	- Oral intake, BID - After first dose 1mg(total 2mg daily), check the blood concentration of everolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 3~8mg/mL.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of composite efficacy failure	composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure	until 24 weeks after taking medicine

Secondary Outcomes

Measure	Description	Time Frame
Incidence of biopsy-confirmed acute rejection	acute rejection confirmed by result of biopsy(over 4 points of RAI score)	until 24 weeks after taking medicine
Pathological result, time of occurrence, treatment method and treatment result of acute rejection confirmed by biopsy(over 4 points of RAI score)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who had liver transplantation from living donor and had passed over 3 months since operation.
Over 20 years old
Patients who are being treated with Tacrolimus at screening visit
Patients who agreed to written informed consent

Exclusion Criteria:

Patients who had received non-liver organs before liver transplantation or had received other organs while receiving liver.
Patients who had auxiliary partial orthotopic liver transplantation or had bioartifical liver
Patients who have been diagnosed with acute rejection within 6 months and have been treated
Patients who had hepatic artery complication such as hepatic artery thrombosis within recent 6 months
Patients who have been diagnosed with malignant tumor within 5 years(however, the following will be excepted)
- fully recovered from skin cancer(squamous cell/basal cell carcinoma or thyroid cancer)
- haptocellular carcinoma without main vessel invasion
Patients with severe systemic infection
Patients who are difficult to communicate due to mental disorder
Patients who are in treatment for hapatitis, or are over 3 times higher than upper normal limit in liver function test(T-bilirubin, AST, ALT) or over 5 times higher than normal limit of ALP
Patients who are(at screening visit)
- WBC<1,500/mm^3
- PLT<30,000/mm^3
- over 1.0 in Protein/creatinine ratio(UA test)
- eGFR<30mL/min/1.73m^2(MDRD)
- Total Cholesterol>350mg/dL or Triglycerides>500mg/dL
Patients taking HCV(hapatitis C virus) therapeutic drug or anti-HCV positive patients who have positive result in HCV RNA test at screening visit
Patients who had plasmapheresis within 1 week
Those who are pregnant, nursing, or are not practicing contraception with appropriate method
Patients who had plasmapheresis within 3 months
if participated in other trail within 4 weeks(28 days)
In investigator's judgement

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D020123	Sirolimus
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals