Efficacy and Safety of Oltipraz in the Patients With Liver Fibrosis and Cirrhosis

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study investigated the effectiveness and safety of oltipraz therapy in treating patients with cirrhosis induced by chronic hepatitis type B or C.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CJ HealthCare Corporation; HK inno.N Corporation
• Treatments: Oltipraz

Criteria

Inclusion Criteria:

• patients with fibrosis and cirrhosis induced by chronic hepatitis type B or C

• patients with HbsAg, Anti-HCV or HCV RNA positive

Exclusion Criteria:

• treatment with antiviral agents, immunosuppressants, glucocorticoids, within the 6 months or with biphenyl dimethyl dicarboxylate one month

• treatment with any investigational drug (except CJ11555PK or CJ-OPZ-201PK) within one month

• Child-Pugh class C, Use of a mean daily dose of 80 g alcohol with the one month, of enzyme inducers or inhibitors, or of drug abuse that might affect this study

• a known hypersensitivity to oltipraz or its structurally related compounds

• ascites, hemorrhage from varicoses, uncompensated LC with the history of hepatic encephalopathy within the 6 months

• hepatocellular carcinoma (a rising serum level of α-fetoprotein or a suspicious foci on hepatic ultrasonography at screening or), liver transplantation

• pregnancy or lactation, unwillingness of contraception during the study period

• other serious concurrent illness (e.g., severe hemorrhagic GI, renal, pulmonary, neurological, cardiovascular (CHF of class III or above; a history of MI within the past 6 months) diseases, or cancer, autoimmunity or psychological diseases)

• any patients who is inappropriate or has unwillingness of clinical study as judged by participating clinicians

• bilirubin content greater than 2.0 mg/dL, prothrombin time longer than 4 sec, and serum albumin below 2.5 g/dL