Safety and Antihepatofibrotic Effect of CGX for Patients with Chronic Liver Diseases : Phase III RCT

Safety and Antihepatofibrotic Effect of CGX for Patients with Alcoholic or Viral Liver Diseases : A Phase III, Multi site, Randomized, Double Blind, Placebo Controlled, Parallel Group Study

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0000773

Enrollment

174

Registered

2013-06-20

Start date

2013-11-08

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : CGX (1g or 2g per day, # 2), for 26 weeks, Oral administration CGX group 1: CGX 1.0g (1g plus placebo 1g per day, # 2) CGX group 2: CGX 2.0g (2g per day, # 2) Placebo group: Placebo 2.0g (2g p

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age from 18 yrs to 75 yrs of man or woman 2) Chronic liver disoders with alcohol abuse or viral infection (HBV or HCV) 3) 5.5 kPa to 16 kPa of LSM (liver stifness measurement) value using Fibroscan? 4) Subjects who are mentally helthy to follow the protocol properly. 5) Subjects who give voluntarily an written consent for the trial.

Exclusion criteria

Exclusion criteria: 1) Subjects who use Immunosuppressive drugs, oragents of cytotoxic or hormone therapy 2) Subjects who have historiesw of ascites, varix bleeding, hepatic encephalopathy 3) Subjects who have a shrunked liver or liver cirrhosis in abdomen sonograph or CT scan 4) Subjects who have esophargeal varices in endoscope 5) Subjects who have ascites, jaundice (TB > 3mg/dl), bleeding tendency (INR>2.0) 6) Severe hepatitis ( 1.2-fold of UNL) 8) Subjects who use currently alcohol or drugs 9) Subjects who have severe disorders in heart, lung, kideny, blood, gall-bladder, or allergy 10) Histoy of malignant tumor 11) Subjects who are in period of pregnancy or lactation, or planning to have a baby 12) Subjects who are 30 > BMI 13) Subjects who are mentally unhelthy to follow the protocol properly. 14) User following drugs, ursodesoxycholic acid, Silymarin, Biphenyl dimethyl dicarboxylate, malotilate, colchicine, prophylthiouracil (PTU), or anti-inflammatory (exception in cases have a washout period over two months)

Design outcomes

Primary

Measure	Time frame
Changed value of LSM (Liver Stiffness Measurement) between before and after	—

Secondary

Measure	Time frame
Changed values of AST to platelet ratio index(APRI);Changed values of cytokine for liver fibrosis, TGF-ß1(Transforming growth factor-ß1), PDGF(Platelet-derived growth factor);Changed values of Quality of life measured by the SF-36;Changed values of parameters for liver fibrosis, hyaluronic acid(HA)	—

Countries

Korea, Republic of

Contacts

Public ContactYoonjung Kim

Daejeon Korean Medicine Hospital of Daejeon University

Outcome results