Conditions: Hepatic Neoplasm Malignant Recurrent
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 616
Healthy volunteers: no

Brief summary:
The purpose of this study is to verify the superiority of NIK-333 (Peretinoin) to placebo in inhibiting the recurrence of HCV-positive HCC in patients showing complete cure of the disease, with the recurrence-free survival as the primary endpoint, in a multi-center, randomized, double-blind, placebo-controlled, parallel-group comparison study.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: NIK-333(peretinoin) intervention 2: Placebo
Intervention descriptions: intervention 1: 600mg (8 x 75mg capsules) orally, twice a day intervention 2: Placebo (8 x Placebo capsules) orally, twice a day

Protocol document: