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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00956098
First Posted: August 11, 2009
Last Update Posted: August 11, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
CJ HealthCare Corporation
  Purpose
This study investigated the effectiveness and safety of oltipraz therapy in treating patients with cirrhosis induced by chronic hepatitis type B or C.

Condition Intervention Phase
Liver Fibrosis Liver Cirrhosis Drug: oltipraz Drug: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by CJ HealthCare Corporation:

Primary Outcome Measures:
  • Ishak fibrosis score [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • The Modified Knodell's HAI score [ Time Frame: 24 weeks ]
  • Child-Pugh score [ Time Frame: 24 weeks ]

Estimated Enrollment: 81
Study Start Date: February 2006
Estimated Study Completion Date: February 2007
Arms Assigned Interventions
Placebo Comparator: placebo Drug: placebo
Experimental: oltipraz Drug: oltipraz
60mg bid 90mg qd

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.
  Eligibility

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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00956098


Locations
Korea, Republic of
The Catholic University of Korea Holy Family Hospital
Sosa-Dong, Wonmi-Gu, Kyungki-Do, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
Banpo-Dong, Seocho-Gu, Seoul, Korea, Republic of
Sponsors and Collaborators
CJ HealthCare Corporation
  More Information

Responsible Party: CJ Cheiljedang Corporation
ClinicalTrials.gov Identifier: NCT00956098     History of Changes
Other Study ID Numbers: CJ-OPZ-201 study
First Submitted: August 10, 2009
First Posted: August 11, 2009
Last Update Posted: August 11, 2009
Last Verified: August 2009

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Oltipraz
Antiviral Agents
Anti-Infective Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics
Antiparasitic Agents
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents