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

Authors
Category Primary study
Registry of TrialsJapan Pharmaceutical Information Center
Year 2014
INTERVENTION: Intervention name : K‐333 Dosage And administration of the intervention : Oral, 600mg daily Control intervention name : Placebo Dosage And administration of the control intervention : Oral CONDITION: Prevention of the recurrence of HCC in patients with complete cure of HBV or HCV‐positive HCC PRIMARY OUTCOME: Recurrence‐free survival SECONDARY OUTCOME: (1)Disease‐free survival; (2)Time to recurrence 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.
Epistemonikos ID: 77e039193f5a8326406fc2e20ec656fecdd0c7bb
First added on: Aug 22, 2024