A randomized phase 2 double-blind, placebo-controlled study of GK-001 in hepatocellular carcinoma (HCC) in chronic hepatitis C patients after prior curative HCC treatment Estudio aleatorizado de fase 2, doble ciego, controlado con placebo sobre GK-001 en pacientes con carcinoma hepatocelular (CHC) y hepatitis C crónica tras tratamiento curativo para el CHC

Conditions: 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: 9.1Level: LLTClassification code 10019830Term: Hepatocellular carcinoma resectable

Registration Number: EUCTR2008-000566-23-ES

Lead Sponsor: GeneCare Research Institute Co., Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 102

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: <35 µM; ALT & AST <10 x Upper Limit of Normal (ULN); Child-Pugh A
•Patients of childbearing potential must use an approved form of contraception (barrier method or abstinence - hormonal contraception is not considered adequate) during the study
•Ability and willingness to comply with the protocol and follow-up

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br><br>To characterize the safety profile of GK-001 in HCC patients with chronic hepatitis C <br>;Primary end point(s): Disease-free survival (DFS): defined as the time from randomization to the first recurrence or occurrence of HCC

Secondary Outcome Measures

Name	Time	Method

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