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Study of Peretinoin for Suppressing Recurrence of HCV-positive HCC

NCT01640808 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 616

Last updated 2020-12-02

Study results available
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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.

Conditions

  • Hepatic Neoplasm Malignant Recurrent

Interventions

DRUG

NIK-333(peretinoin)

600mg (8 x 75mg capsules) orally, twice a day

DRUG

Placebo

Placebo (8 x Placebo capsules) orally, twice a day

Sponsors & Collaborators

  • Kowa Company, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2016-10-31
Completion
2016-11-30

Countries

  • Japan

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01640808 on ClinicalTrials.gov