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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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222445
Enrollment
600
Registered
2014-03-31
Start date
2014-07-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of the recurrence of HCC in patients with complete cure of HBV or HCV-positive HCC

Interventions

investigational material(s) Generic name etc : K-333 INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material :

Sponsors

Kowa Company, Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Patients with the HCC related to hepatitis virus other than HBV and HCV etc.

Design outcomes

Primary

MeasureTime frame
efficacy confirmatory Recurrence-free survival Time to recurrence of HCC or death, regardless of cause

Secondary

MeasureTime frame
efficacy (1)Disease-free survival (2)Time to recurrence (1)Time to recurrence of HCC, death, regardless of cause, or occurrence of secondary cancer (2)Time to recurrence of HCC

Countries

Asia except Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026