NCT00165633

A Phase II/III Clinical Study on Inhibitory Effects of E0167 on Recurrence of Hepatocellular Carcinoma

A Randomized, Placebo-Controlled, Phase II/III Clinical Study on Inhibitory Effects of E0167 on Recurrence of Hepatocellular Carcinoma

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: Eisai Limited · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the superiority of inhibitory effects and safety of Menatetrenone (E0167) on recurrence in patients with hepatocellular carcinoma.

Detailed description

The study was conducted as a multicenter, randomized, parallel, placebo-controlled, double-blind comparative clinical study. Patients were randomly assigned in a double-blind manner to receive 45 or 90 mg/day of oral vitamin K2 or an identical-appearing placebo. Study drug was administered orally three times daily after meals until recurrence.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Menatetrenone	45 mg capsule, orally, three times a day, after meals.
DRUG	Menatetrenone	90 mg capsule, orally, three times a day, after meals.
DRUG	Placebo	Placebo capsule, orally, three times a day, after meals.

Timeline

• Start date: 2004-03-01
• Completion: 2007-03-01
• First posted: 2005-09-14
• Last updated: 2008-12-09

Locations

30 sites across 1 country: Japan