IK-333 phase2/3study
Phase 2
- Conditions
- HCV-positive HCC patients after curative treatment
- Registration Number
- JPRN-jRCT2080220246
- Lead Sponsor
- KOWA COMPANY,LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 360
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 Recurrence-free survival<br>Time to recurrence of HCC or death, regardless of cause
- Secondary Outcome Measures
Name Time Method Disease-free survival<br>Time to recurrence of HCC, death, regardless of cause, or occurrence of secondary cancer (malignant tumors other than HCC)