A phase 3, placebo-controlled, multi-center, randomized, double-blind trial to evaluate the efficacy and safety of K-333 (peretinoin) in patients with complete cure of hepatocellular carcinoma in Asia
Phase 3
Completed
- Conditions
- Prevention of the recurrence of HCC in patients with complete cure of HBV or HCV-positive HCC
- Registration Number
- JPRN-jRCT2080222445
- Lead Sponsor
- Kowa Company, Ltd.
- Brief Summary
K-333 was considered as a well-tolerated drug, but the superiority of K-333 to placebo in terms of the recurrence-inhibiting effect in patients with complete cure of HCC was not verified in this study. And it was considered that further investigations to define the cause of this result would be required.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 631
Inclusion Criteria
(1)Patients with the primary occurrence or the first recurrence of HBV- or HCV-related HCC
(2)Patients showing that a complete cure was confirmed by either local ablation or surgical resection
(3)Patients of the age of 20 years or older at the time of informed consent
etc.
Exclusion Criteria
Patients with the HCC related to hepatitis virus other than HBV and HCV
etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method