Clinical pharmacology study of NIK-333
Phase 1
- Conditions
- HCV-positive HCC patients after curative treatment
- Registration Number
- JPRN-jRCT2080221715
- Lead Sponsor
- Kowa Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Patients who signed written informed consent
Patients who underwent a local therapy or surgical resection after diagnosis of HCV-positive HCC and who subsequently were confirmed by CT of showing a complete cure of HCC
Patients confirmed of satisfying the following conditions based on the screening performed at subject registration
1)Presence of HCV-RNA in serum
2)Grade A or B on Child-Pugh classification
Exclusion Criteria
Patients positive for hepatitis B surface (HBs) antigen
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gene expression profile<br>Liver and peripheral blood gene expression profiles determined by the microarray method
- Secondary Outcome Measures
Name Time Method Safety<br>Adverse events, physiological tests, laboratory tests (hematology tests, blood biochemistry tests, urinalyses, blood pressure parameters), abdominal imaging diagnosis, endoscopy (esophagus/stomach), bone mineral analysis (DXA method), ECG, echocardiography, pulse wave examination (PWV/ABI), fundus examination