UnknownPhase 4

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

South Korea112 participantsStarted 2021-03-16

Plain-language summary

To evaluate the efficacy and safety of CertiroBell® tablet plus tacrolimus

Age range20 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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)
✕. 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

Incidence of composite efficacy failure

Timeframe: until 24 weeks after taking medicine

NCT IDNCT04867720

SponsorChong Kun Dang Pharmaceutical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-10-10

Kyung-Suk Suh, M.D., Ph.D.