At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 616 enrolled
Drug / intervention
NIK-333(peretinoin) +1 moredrug
Likely dose
NIK-333(peretinoin) 600mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating NIK-333(peretinoin) and Placebo for Hepatic Neoplasm Malignant Recurrent. Completed, enrolled 616 participants across 66 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Neoplasm Malignant Recurrent
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2012
First PostedJul 2012
Primary CompletionOct 2016
Study CompletionNov 2016
TodayJul 2026
First PostedJul 16, 2012
Enrollment StartApr 1, 2012
Primary CompletionOct 1, 2016
Study CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 14.0 years ago
Interventions
NIK-333(peretinoin)drug
600mg (8 x 75mg capsules) orally, twice a day
Placebodrug
Placebo (8 x Placebo capsules) orally, twice a day