Status and phase
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About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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).
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 meet the following items to determine liver function:
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.
Exclusion criteria
Hepatocellular carcinoma:
Hepatitis:
-- 1) Patients of (a) or (b) previously treated with interferon preparations (including clinical studies).
Systemic conditions:
Drug administration:
Other exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
540 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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