Status:
COMPLETED
Efficacy and Safety of Oltipraz in the Patients With Liver Fibrosis and Cirrhosis
Lead Sponsor:
HK inno.N Corporation
Conditions:
Liver Fibrosis
Liver Cirrhosis
Eligibility:
All Genders
25-65 years
Phase:
PHASE2
Brief Summary
This study investigated the effectiveness and safety of oltipraz therapy in treating patients with cirrhosis induced by chronic hepatitis type B or C.
Detailed Description
Oltipraz \[5-(2-pyrazinyl)-4-methyl-1,2-dithiol-3-thione\] has been extensively studied as a cancer chemopreventive agent. Comprehensive mechanistic and phase IIa studies supported the notion that olt...
Eligibility Criteria
Inclusion
- patients with fibrosis and cirrhosis induced by chronic hepatitis type B or C
- patients with HbsAg, Anti-HCV or HCV RNA positive
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00956098
Start Date
February 1 2006
End Date
February 1 2007
Last Update
August 11 2009
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
The Catholic University of Korea Holy Family Hospital
Sosa-Dong, Wonmi-Gu, Gyeonggi-do, South Korea
2
The Catholic University of Korea Seoul St. Mary's Hospital
Banpo-Dong, Seocho-Gu, Seoul, South Korea