None listed
Conditions
Interventions
Drug : This study is a multi-center, randomized, double-blind, parallel-group (2-arm), phase 3 study to verify the non-inferiority and safety of CTP-JB02 compared to CTP-JS01 (GODEX®) for the SGPT lev
Sponsors
Celltrion Pharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects have to meet all of the following criteria: 1. Those who voluntarily gave their written consent to participate in the clinical study 2. Those between the ages of 19 and 70 with confirmed chronic liver disease (viral hepatitis or non-alcoholic fatty liver disease [NAFLD]) 3. Those whose results of SGPT test, performed at least 1 month apart within 6 months prior to Visit 1 (Screening), showed an increase of 45 IU/L or more for men and 29 IU/L or more for women at least once, with an increase of 45 IU/L or more for men and 29 IU/L or more for women in the results of SGPT test performed at Visit 1 (Screening) as well 4. Those who have not taken hepatotonic agents such as BDD, UDCA, and silymarin during the following period prior to Visit 1 (Screening) - BDD, Silymarin: 14 days - UDCA: 30 days - Other hepatotonic agents: 5 half-lives or more
Exclusion criteria
Exclusion criteria: If any of the following conditions were met, the subject could not participate in this clinical study: 1. Those with a history of esophageal variceal bleeding, hepatic coma, ascites within 1 year prior to Visit 1 (Screening), or who fall under Child-Pugh B or C 2. Those with alcohol intake in excess of 210 g/week for men and 140 g/week for women in the 2 years prior to Visit 1 (Screening) 3. Those who meet one or more of the following at Visit 1 (Screening) - Those with a history of liver cancer or other malignant tumor within 5 years - Those with a history of organ transplantation or bone marrow transplantation - Those with biliary atresia, hereditary metabolic liver disease, fulminant hepatitis, toxic or clinically diagnosed drug-induced hepatitis, hemorrhagic or platelet disease - Those with infectious diseases such as sepsis and tuberculosis - Those with uncontrolled serious cardiopulmonary disease - Uncontrolled thyroid dysfunction - Patients with uncontrolled diabetes (HbA1c >8.5%) - Those with other uncontrolled serious systemic disease - Those with pancreatitis, inflammatory bowel disease, severe autoimmune disease, or severe respiratory disease - Those who have received bariatric surgery within 6 months - Those with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc. 4. Those who meet one or more of the following as a result of the tests conducted at Visit 1 (Screening) - SGPT > 400 IU/L - SGOT > 400 IU/L - Serum creatinine > 2 mg/dL - Hemoglobin 1.5 mg/dL - Prothrombin time (INR) > 2.3 - Serum albumin 40 mg/day for at least 1 week or > 10 mg/day for at least 2 weeks) or immunosuppressive therapy within 30 days prior to Visit 1 (Screening), or need to take them continuously/repeatedly 9. Those who had been taking the following drugs continuously for at least 2 weeks at Visit 1 (Screening), or need to take them continuously/repeatedly - Antituberculosis drugs such as isoniazid and rifampin and anti-biotics or other anti-biotics - Anti-convulsants such as phenobarbital or anti-depressants - Anti-psychotics such as phenothiazines - NSAIDs, acetaminophen - Vitamin E, thiazolidinediones, anti-obesity drugs, pentoxifylline - Levodopa, methotrexate, allopurinol, methyldopa, hydralazine, cholestyramine, warfarin, coumarin, digoxin 10. Those with hypersensitivity to any component of the investigational product 11. Pregnant or lactating women or women of childbearing potential and men who do not agree to use the following appropriate contraceptive methods during the participation in this clinical study and until
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SGPT normalization rate | — |
Secondary
| Measure | Time frame |
|---|---|
| SGPT normalization rate;Changes in SGPT;Changes in MRI-PDFF;Safety | — |
Countries
Korea, Republic of
Contacts
Public ContactDo Young Kim
Yonsei University Health System, Severance Hospital
Outcome results
None listed