Efficacy and Safety of Oltipraz in the Patients With Liver Fibrosis and Cirrhosis
A Randomized, Double-Blind, Placebo-Controlled Phase II Multicenter Trial of Oltipraz for the Evaluation of Efficacy and Safety in the Patients With Liver Fibrosis and Cirrhosis Induced by Chronic Hepatitis Type B or C
1 other identifier
interventional
81
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2006
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 10, 2009
CompletedFirst Posted
Study publicly available on registry
August 11, 2009
CompletedAugust 11, 2009
August 1, 2009
August 10, 2009
August 10, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Ishak fibrosis score
24 weeks
Secondary Outcomes (2)
The Modified Knodell's HAI score
24 weeks
Child-Pugh score
24 weeks
Study Arms (2)
placebo
PLACEBO COMPARATORoltipraz
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- patients with fibrosis and cirrhosis induced by chronic hepatitis type B or C
- patients with HbsAg, Anti-HCV or HCV RNA positive
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The Catholic University of Korea Holy Family Hospital
Sosa-Dong, Wonmi-Gu, Gyeonggi-do, South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Banpo-Dong, Seocho-Gu, Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 10, 2009
First Posted
August 11, 2009
Study Start
February 1, 2006
Study Completion
February 1, 2007
Last Updated
August 11, 2009
Record last verified: 2009-08