Study of Peretinoin for Suppressing Recurrence of HCV-positive HCC

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.

Timeline

Start

2012-04

Primary completion

2016-10

Completion

2016-11

Outcome

Missed primary endpoint

registry analysis (superiority test); NIK-333(Peretinoin) vs Placebo; p = 0.351; Hazard Ratio (HR) 0.900 (95% CI 0.720 to 1.124); Log Rank NCT01640808 ↗

Publications

• Qin XY, Shirakami Y, Honda M, Yeh SH, Numata K, Lai YY, Li CL, Wei F, Xu Y, Imai K, Takai K, Chuma M, Komatsu N, Furutani Y, Gailhouste L, Aikata H, Chayama K, Enomoto M, Tateishi R, Kawaguchi K, Yamashita T, Kaneko S, Nagaoka K, Tanaka M, Sasaki Y, Tanaka Y, Baba H, Miura K, Ochi S, Masaki T, Kojima S, Matsuura T, Shimizu M, Chen PJ, Moriwaki H, Suzuki H. Serum MYCN as a predictive biomarker of prognosis and therapeutic response in the prevention of hepatocellular carcinoma recurrence. Int J Cancer. 2024 Aug 1;155(3):582-594. doi: 10.1002/ijc.34893. Epub 2024 Feb 21.

Drugs

Indications