Clinical Trial for Anti-hepatofibrotic Efeect of a Traditional Korean Formula (CGX) in Patients with Chronic Liver Disease

Abstract

Purpose: CGX is a modification of a traditional Korean herbal medicine, which is under clinical trial phase III for hepatofibrosis therapeutic effect. The objective is to present the status for CGX development regarding its clinical backgrounds, pharmacological studies in animal models, and current process of randomized clinical trial. Methods: CGX has been used for patients suffering various liver diseases, including chronic viral hepatitis and alcoholic liver disorders. The safety of CGX was evaluated in animalbased repeated toxicological studies using rats and beagle dogs. The pharmacological actions against hepatic fibrosis were evidenced in various chronic liver injury animal models using chemicals (CCl4, DMN, or TAA), chronic alcohol consumption, choline-deficient (MCD) diet, and bile duct ligation (BDL) respectively. It is now under a ramdomized controlled multicenter trial.phase III for hepatofibrosis. Results: The total number of participants is 174 in 2 Hospitals, who are suffering from chronic HBV, HCV or Alcoholic liver disease. The inclusion criteria is patientswith LSM5.5 kPa to 16kPa, aged between 18∼75 year. The exclusion criteria is the conditions of too severe status as follows; ascites, esophageal varix, TB > 3mg/dl, AST, ALT > ULN > 5 folds, INR > 2.0 or platelet 30. The drug treatment period is 6 months for 3 groups (placebo, 1gram or 2 gram of CGX daily). The primary measurement is the changed value of LSM (liver stiffness mesurement) during 6 months, and the secondary measurements are the changed value of hyaluronic acid (HA), serumTGF1, PDGF, AST to platelet ratio index (APRI) and QOL (SF-36) respectively. Conclusion: It is expected that multi-sites clinical trial evidences the fibro-therapeutic effects of CGX in patients with chronic viral or alcoholic liver diseases. Contact: Chang Gue Son, ckson@dju.ac.kr