E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
hepatocellular carcinoma (HCC) in chronic hepatitis C patients after prior curative HCC treatment |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019830 |
E.1.2 | Term | Hepatocellular carcinoma resectable |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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) |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Disease-free survival (DFS): defined as the time from randomization to the first recurrence or occurrence of HCC |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 15 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 18 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |