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Hepatocellular CarcinomaPhase 2/3NCT00165633

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

A Phase 2/3 study testing Menatetrenone in people with Hepatocellular Carcinoma, run by Eisai Limited at 30 sites in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Menatetrenone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
540 participants
Where
30 sitesJapan
Study dates
Mar 2004to Mar 2007
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 20 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).
  • 1) Patients who are confirmed to have early tumor stain and typical finding(s) of hepatocellular carcinoma with CT or MRI imaging
  • 2) 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.
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  • Patients who underwent the following 1) or 2) within 90 days prior to registration to determine therapeutic effect.
  • 1) Patients who underwent local therapy to achieve complete hepatonecrosis and are confirmed to have complete hepatonecrosis with CT imaging or MRI.
  • 2) 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:
  • 1) Albumin is 2.8 g/dL or above
  • 2) Total bilirubin is under 2.0 mg/dL
  • 3) 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.

Who cannot join

  • Hepatocellular carcinoma:
  • 1) Patients who have extrahepatic metastasis
  • 2) Patients who have portal invasion
  • 3) Patients who experienced with systemic administration of anti-malignant tumor drugs to treat hepatocellular carcinoma
  • 4) Patients treated with transcatheter arterial chemoembolization (TAE) alone as a non-local therapy for hepatocellular carcinoma
  • Hepatitis:
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  • -- 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:
  • 1) Patients unable to receive oral administration
  • 2) Patients with a history of gastrectomy or extensive resection of digestive tract
  • 3) Patients who are suspected to have biliary occlusion, choleretic disorder, cholecystectomy, or malabsorption of liposoluble agents
  • 4) Patients with complicated serious diseases such as cardiovascular (e.g., myocardial infarction), hematological (e.g., aplastic anemia), and/or renal dysfunctions (e.g., acute and chronic renal failure)
  • 5) Patients with multiple cancers (within a 5-year cancer-free period [from the same day of 5 years earlier to the day of obtaining consent forms])
  • Drug administration:
  • 1) Patients on warfarin potassium therapy
  • 2) Patients with a known history of drug allergy to E0167 or its ingredients
  • 3) Patients who received vitamin K preparations within the recent 6 months (from the same day of 6 month earlier to the day of obtaining consent forms)
  • Other exclusion criteria
  • 1) Women of pregnant, lactating, childbearing potential, or with the intention of becoming pregnant
  • 2) Patients who are presently participating in another clinical study (except for follow-up surveys for study outcomes)
  • 3) Patients who are judged to be ineligible for study entry by the investigator or subinvestigator

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

Japan30 sites

  • Study site

    Bunkyo-ku, Tokyo, 113-0033

  • Study site

    Chiyoda-ku, Tokyo, 101-0024

  • Study site

    Fukuoka, Fukuoka, 814-0133

  • Study site

    Hitachi, Ibaraki, 317-0077

  • Study site

    Kanazawa, Kanazawa-prefecture, 920-0934

  • Study site

    Kawasaki, Kanagawa, 213-0001

  • Study site

    Kurashiki, Okayama-ken, 710-0052

  • Study site

    Kurume, Fukuoka, 830-0011

  • Study site

    Moriguchi, Osaka, 570-0074

  • Study site

    Morioka, Iwate, 020-0023

  • Study site

    Naka, Hiroshima, 730-001

  • Study site

    Niigata, Niigata, 951-8122

  • Study site

    Ōita, Oita Prefecture, 879-5503

  • Study site

    Okayama, Okayama-ken, 700-0013

  • Study site

    Okayama, Okayama-ken, 700-0014

  • Study site

    Osaka, Osaka, 537-0025

  • Study site

    Osaka, Osaka, 543-0021

  • Study site

    Osaka, Osaka, 543-0027

  • Study site

    Saga, Saga-ken, 840-0054

  • Study site

    Saga, Saga-ken, 849-0937

  • Study site

    Sapporo, Hokkaido-prefecture, 006-8111

  • Study site

    Sapporo, Hokkaido-prefecture, 060-0033

  • Study site

    Sayama, Osaka, 589-0014

  • Study site

    Senndai, Miyagi, 980-0872

  • Study site

    Setagaya-ku, Tokyo, 158-0098

  • Study site

    Shibuya-ku, Tokyo, 151-0053

  • Study site

    Shinjuku-ku, Tokyo, 162-0052

  • Study site

    Shizuoka, Shizuoka, 420-0881

  • Study site

    Ube, Yamaguchi, 755-0046

  • Study site

    Wakayama, Wakayama, 641-0012

Other trials in Japan

About this study

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

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.

Read the 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.

Being tested
Menatetrenone, Placebo
Keywords
Hepatocellular, Carcinoma, Hepatitis C Virus, Hepatitis B Virus, recurrence, Vitamin K2, E0167
Medical subject headings
Carcinoma, Hepatocellular, Carcinoma, Hepatitis C, Hepatitis B, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MenatetrenoneDrug

    Also called E0167

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

  • MenatetrenoneDrug

    Also called E0167

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

  • PlaceboDrug

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

Study groups in NCT00165633
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: Menatetrenone
2ExperimentalNot described
Receives: Drug: Menatetrenone
3Placebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relapse-free survival period.

    Measured: Every 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2005 (estimated)
  2. Study startMar 2004
  3. Study completionMar 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
540 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00165633
Sponsor's protocol ID
E0167-J081-551
Status last verified
Dec 2008
First submitted
12 Sep 2005
Last updated
9 Dec 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Menatetrenone in people with Hepatocellular Carcinoma, run by Eisai Limited at 30 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relapse-free survival period. (time frame: Every 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00165633.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2008.

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