hepatocellular carcinoma (HCC) in chronic hepatitis C patients after prior curative HCC treatment carcinoma hepatocelular (CHC) en pacientes con hepatitis C crónica tras tratamiento curativo para el CHC MedDRA version: 9.1 Level: LLT Classification code 10019830 Term: Hepatocellular carcinoma resectable
Conditions
Interventions
Product Name: GK-001
Pharmaceutical Form: Capsule*
Current Sponsor code: GK-001
Other descriptive name: (2S,12Z,14E,16S,17S,18R,19R,20R,21S,22R,23S,24E)-1,2-dihydro-5,6,9,17,19- pentahydroxy-23-methox
Sponsors
GeneCare Research Institute Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed informed consent obtained prior to initiation of any study-specific procedures • Previous HCC diagnosis (according to AASLD 2005 Guidelines) for which the patient has undergone 1-2 potentially curative treatments (PEI, RFA, surgical resection) • T2N0M0 or T3N0M0 HCC diagnosis prior to curative treatment • A dynamic CT-scan showing no evidence of HCC with proof of cancer-free margins within 30 days of randomization; scan must be performed 1-3 months after curative treatment • Diagnosis of chronic hepatitis C • Age = 18 years • ECOG Performance Status (PS): 0-1 • Liver function: total bilirubin: =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Diseases other than hepatitis which can influence ALT values (e.g. polymyositis, cholelithiasis) • Dialysis patients • Co-infection with HCV-HBV • Evidence of residual tumor • History of allergic reactions to compounds of similar chemical or biological composition to GK-001 • Concurrent radiotherapy or chemotherapy; concurrent immunotherapy with IFN is permitted • Systemic chemotherapy, radiotherapy or immunotherapy for HCC during the 6 weeks prior to randomization • Administration of an investigational agent during the 4 weeks prior to randomization • Use of GK-001 in the 12 months prior to randomization • Concurrent anti-HIV drugs, tuberculostatic drugs other than Rifampicin • Alcohol consumption >30 g/day for males and >20 g/day for females • Planned initiation of treatment with liver-supporting medications, e.g. UDCA; patients receiving UDCA prior to study screening must continue at the same dose • Pregnant or breast-feeding women • Presence of porphyrinuria, methicillin-resistant Staphylococcus (MRSA) infection, tuberculosis, autoimmune hepatitis, drug-associated hepatitis, diabetes treated with hypoglycemic oral agents • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, HIV, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any other psychiatric disorder or social situations which could hamper compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of GK-001 in chronic hepatitis C patients who have undergone prior curative HCC treatment (percutaneous ethanol injection [PEI], radiofrequency ablation [RFA], surgical resection);Secondary Objective: To characterize efficacy parameters in placebo treated patients, for use in formulation of hypotheses in future trials To characterize the safety profile of GK-001 in HCC patients with chronic hepatitis C ;Primary end point(s): Disease-free survival (DFS): defined as the time from randomization to the first recurrence or occurrence of HCC | — |
Countries
France, Spain
Outcome results
None listed