NCT00165633

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
540

participants targeted

Target at P75+ for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Mar 2004

Typical duration for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

30 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

December 9, 2008

Status Verified

December 1, 2008

First QC Date

September 12, 2005

Last Update Submit

December 5, 2008

Conditions

Hepatocellular Carcinoma

Keywords

HepatocellularCarcinomaHepatitis C VirusHepatitis B VirusrecurrenceVitamin K2E0167

Outcome Measures

Primary Outcomes (1)

  • Relapse-free survival period.

    Every 3 months

Study Arms (3)

1

EXPERIMENTAL
Drug: Menatetrenone

2

EXPERIMENTAL
Drug: Menatetrenone

3

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MenatetrenoneDRUG

45 mg capsule, orally, three times a day, after meals.

Also known as: E0167
1
PlaceboDRUG

Placebo capsule, orally, three times a day, after meals.

3

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older at the time of obtaining consent.
  • Systemic conditions are 0 to 2 score of Performance Status (according to Eastern Cooperative Oncology Group: ECOG).
  • Diagnosis of hepatocellular carcinoma is based on the following 1) or 2).
  • \) Patients who are confirmed to have early tumor stain and typical finding(s) of hepatocellular carcinoma with CT or MRI imaging
  • \) Patients who underwent tumor biopsy and are histopathologically diagnosed as hepatocellular carcinoma
  • Primary onset or recurrence of hepatocellular carcinoma is not more than 1 time.
  • Patients who underwent the following 1) or 2) within 90 days prior to registration to determine therapeutic effect.
  • \) Patients who underwent local therapy to achieve complete hepatonecrosis and are confirmed to have complete hepatonecrosis with CT imaging or MRI.
  • \) Patients who underwent surgical treatment(s) and are confirmed not to have residual tumor with CT or MRI imaging.
  • Patients who meet the following items to determine liver function:
  • \) Albumin is 2.8 g/dL or above
  • \) Total bilirubin is under 2.0 mg/dL
  • \) Prothrombin activation is 40% or above
  • Patients who are given full explanation of study participation (including cancer notification) and submit written consent forms with their understanding as well as voluntary will for this study.

You may not qualify if:

  • Hepatocellular carcinoma:
  • \) Patients who have extrahepatic metastasis
  • \) Patients who have portal invasion
  • \) Patients who experienced with systemic administration of anti-malignant tumor drugs to treat hepatocellular carcinoma
  • \) Patients treated with transcatheter arterial chemoembolization (TAE) alone as a non-local therapy for hepatocellular carcinoma
  • Hepatitis:
  • \-- 1) Patients of (a) or (b) previously treated with interferon preparations (including clinical studies).
  • (a) Patients with chronic hepatitis C virus (HCV) showing HCV-RNA negative
  • (b) Patients with viral hepatitis treated with interferon preparations within the last 2 years (from the same day, 6 months earlier to the day of obtaining consent forms)
  • (c) Patients with encephalopathy in which pharmacotherapy is ineffective
  • (d) Patients with ascites or pleural effusion that cannot be managed with diuretics
  • Systemic conditions:
  • \) Patients unable to receive oral administration
  • \) Patients with a history of gastrectomy or extensive resection of digestive tract
  • \) Patients who are suspected to have biliary occlusion, choleretic disorder, cholecystectomy, or malabsorption of liposoluble agents
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Unknown Facility

Fukuoka, Fukuoka, 814-0133, Japan

Location

Unknown Facility

Kurume, Fukuoka, 830-0011, Japan

Location

Unknown Facility

Naka, Hiroshima, 730-001, Japan

Location

Unknown Facility

Sapporo, Hokkaido-prefecture, 006-8111, Japan

Location

Unknown Facility

Sapporo, Hokkaido-prefecture, 060-0033, Japan

Location

Unknown Facility

Hitachi, Ibaraki, 317-0077, Japan

Location

Unknown Facility

Morioka, Iwate, 020-0023, Japan

Location

Unknown Facility

Kawasaki, Kanagawa, 213-0001, Japan

Location

Unknown Facility

Kanazawa, Kanazawa-prefecture, 920-0934, Japan

Location

Unknown Facility

Senndai, Miyagi, 980-0872, Japan

Location

Unknown Facility

Niigata, Niigata, 951-8122, Japan

Location

Unknown Facility

Ōita, Oita Prefecture, 879-5503, Japan

Location

Unknown Facility

Kurashiki, Okayama-ken, 710-0052, Japan

Location

Unknown Facility

Okayama, Okayama-ken, 700-0013, Japan

Location

Unknown Facility

Okayama, Okayama-ken, 700-0014, Japan

Location

Unknown Facility

Moriguchi, Osaka, 570-0074, Japan

Location

Unknown Facility

Osaka, Osaka, 537-0025, Japan

Location

Unknown Facility

Osaka, Osaka, 543-0021, Japan

Location

Unknown Facility

Osaka, Osaka, 543-0027, Japan

Location

Unknown Facility

Sayama, Osaka, 589-0014, Japan

Location

Unknown Facility

Saga, Saga-ken, 840-0054, Japan

Location

Unknown Facility

Saga, Saga-ken, 849-0937, Japan

Location

Unknown Facility

Shizuoka, Shizuoka, 420-0881, Japan

Location

Unknown Facility

Bunkyo-ku, Tokyo, 113-0033, Japan

Location

Unknown Facility

Chiyoda-ku, Tokyo, 101-0024, Japan

Location

Unknown Facility

Setagaya-ku, Tokyo, 158-0098, Japan

Location

Unknown Facility

Shibuya-ku, Tokyo, 151-0053, Japan

Location

Unknown Facility

Shinjuku-ku, Tokyo, 162-0052, Japan

Location

Unknown Facility

Wakayama, Wakayama, 641-0012, Japan

Location

Unknown Facility

Ube, Yamaguchi, 755-0046, Japan

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularCarcinomaHepatitis CHepatitis BRecurrence

Interventions

menatetrenone

Condition Hierarchy (Ancestors)

AdenocarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisHepadnaviridae InfectionsDNA Virus InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nozomu Koyanagi

    Eisai Co., Ltd - Development Clinical Research Department. Clinical Research Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 14, 2005

Study Start

March 1, 2004

Study Completion

March 1, 2007

Last Updated

December 9, 2008

Record last verified: 2008-12

Locations

JP(30)