EUCTR2008-000566-23-FR
Active, not recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GeneCare Research Institute Co., Ltd.
- Enrollment
- 102
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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: \<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
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
Outcomes
Primary Outcomes
Not specified
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