Back to resultsEfficacy and Safety of Oltipraz in the Patients With Liver Fibrosis and Cirrhosis
Primary Purpose
Liver Fibrosis, Liver Cirrhosis
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
oltipraz
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Liver Fibrosis
Eligibility 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
Sites / Locations
- The Catholic University of Korea Holy Family Hospital
- The Catholic University of Korea Seoul St. Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
placebo
oltipraz
Arm Description
Outcomes
Primary Outcome Measures
Ishak fibrosis score
Secondary Outcome Measures
The Modified Knodell's HAI score
Child-Pugh score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00956098
Brief Title
Efficacy and Safety of Oltipraz in the Patients With Liver Fibrosis and Cirrhosis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
HK inno.N Corporation
4. Oversight
5. Study Description
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 oltipraz exerts chemopreventive effects, as supported by Phase IIa human clinical studies of oltipraz on cancer chemoprevention, conducted in Qidong, China. Hepatic stellate cells cause synthesis of large quantities of extracellular matrix. Transforming growth factor beta1 (TGF-beta1), as a key fibrogenic mediator for fibrogenesis after injuries through deposition of extracellular matrix and inhibition of collagenase activity in the liver, is associated with the regulation of cell growth and differentiation and causes synthesis of extracellular matrix proteins and cellular receptors for matrix proteins. Previously, we reported the effectiveness of oltipraz in regeneration of cirrhotic liver, which includes reduction of the intensities of liver fibrotic and cirrhotic nodules, elimination of accumulated extracellular matrix, and regeneration of cirrhotic liver in animal models. Oltipraz completely resolves fibrosis in the cirrhotic liver, thereby improving viability. TGF-beta1 signaling plays an important role in liver fibrogenesis and cirrhosis as evidenced by receptor knockout experiments. No therapeutic agent that is active in interrupting TGF-beta1 signaling is available, proposing that C/EBP serve as a molecular target for the treatment of liver cirrhosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Fibrosis, Liver Cirrhosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
81 (false)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
oltipraz
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
oltipraz
Intervention Description
60mg bid 90mg qd
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Ishak fibrosis score
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
The Modified Knodell's HAI score
Time Frame
24 weeks
Title
Child-Pugh score
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
The Catholic University of Korea Holy Family Hospital
City
Sosa-Dong, Wonmi-Gu
State/Province
Kyungki-Do
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Banpo-Dong, Seocho-Gu
State/Province
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Oltipraz in the Patients With Liver Fibrosis and Cirrhosis
We'll reach out to this number within 24 hrs