A Study of K-333 (peretinoin) in Patients with Complete Cure of Hepatitis B Virus (HBV)-Positive Hepatocellular Carcinoma
Phase 3
Completed
- Conditions
- Prevention of the recurrence of HCC in patients with complete cure of HBV-positive HCC
- Registration Number
- JPRN-jRCT2080222099
- Lead Sponsor
- Kowa Company, Ltd.
- Brief Summary
It was indicated that K-333 600 mg/day (twice daily) was well tolerated, and has a possibility to inhibit recurrence of hepatocellular carcinoma in patients with confirmed complete cure of hepatitis B virus (HBV)-positive hepatocellular carcinoma. Since the results were obtained from the exploratory study, further consideration is needed going forward.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria
(1)Patients with HBV-positive HCC of the first primary or the first recurrence of primary 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 who received the radical therapy to HCV-related HCC
etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>exploratory<br>Recurrence-free survival<br>Time to recurrence of HCC or death, regardless of cause
- Secondary Outcome Measures
Name Time Method efficacy<br>(1)Disease-free survival<br>(2)Time to recurrence<br>(1)Time to recurrence of HCC, death, regardless of cause, or occurrence of secondary cancer<br>(2)Time to recurrence of HCC