Last reviewed · How we verify
NIK-333(Peretinoin) PhaseⅢ Study Investigation of the Efficacy and Safety to Suppress Recurrence of Hepatitis C Virus(HCV)-Positive Hepatocellular Carcinoma(HCC), Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel-group Study
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.
Details
| Lead sponsor | Kowa Company, Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 616 |
| Start date | 2012-04 |
| Completion | 2016-11 |
Conditions
- Hepatic Neoplasm Malignant Recurrent
Interventions
- NIK-333(peretinoin)
- Placebo
Primary outcomes
- Recurrence-free Survival — Date of randomization to the date of recurrence of HCC (followed every 12 weeks) or death (whichever occurs first)
HCC recurrence was defined as the appearance of new intrahepatic lesions which was confirmed based on findings of hypervascularity (nodules enhanced in the arterial phase and washout in the late phase) by dynamic CT images, or a new extrahepatic metastasis. Recurrence of intrahepatic HCC was evaluated by an independent image reading committee. RFS was defined as the time from randomization to HCC recurrence or death from any cause, whichever occurred first. For subjects who terminated the study without HCC recurrence or death, RFS was censored at the day of the latest dynamic CT examination.
Countries
Japan