A multicenter, randomized controlled trial of entecavir treatment for the patients with hepatocellular carcinoma complicated with chronic hepatitis B or cirrhosis after a curative treatment of the cancer: Anti-virus effect, influence on hepatic reserve, cancer recurrence, and survival.

A multicenter, randomized controlled trial of entecavir treatment for the patients with hepatocellular carcinoma complicated with chronic hepatitis B or cirrhosis after a curative treatment of the cancer: Anti-virus effect, influence on hepatic reserve, cancer recurrence, and survival. - Effect of entecavir treatment on cancer recurrence after a curative therapy of hepatocellular carcinoma complicated with chronic hepatitis B or cirrhosis.

Status

Unknown

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000597

Enrollment

170

Registered

2007-08-01

Start date

2006-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis B and cirrhosis after a curative treatment of hepatocellular carcinoma

Interventions

Entecavir arm: entecavir (brand name: Baraclude) administration orally in a daily dose of 0.5mg before retiring at night, is started within 1 month after registration, and continued for 48 months. Af

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Chronic hepatitis B or cirrhosis with positive HBsAg and HBV DNA above 5.0 log copies/ml.(2) Hepatocellular carcinoma of the patient, na&iuml;ve or recurrent, has been curably treated with radiofrequency ablation therapy or hepatic resection resection and recurrence is not detected by enhancement CT or enhancement MRI within 3 months before the registration.

Exclusion criteria

Exclusion criteria: (1)The patients who has an allergy against nucleos(t)ide analogues(2)The patients who have received interferon or nucleoside analogue within 6 months before registration(3) Pregnant women, or women who are nursing.(4)The patients with other chronic liver disease, such as autoimmune hepatitis, primary biliary cirrhosis, alcoholic hepatitis, or chronic hepatitis C.(5)The patients with an uncontrollable heart trouble (myocardial infarction, heart failure, or arrhythmia)(6)The patients with chronic renal failure or chronic respiratory failure(7)The patients who were thought to be inapproriate for this study by the doctor

Design outcomes

Primary

Measure	Time frame
(1)Recurrence-free survival: recurrence or not is diagnosed by enhanced CT, enhanced MRI, or ultrasonography.(2)AFP, AFP-L3, PIVKA-II (3)Survival (4)Event-free survival, i.e., survival without gastrointestinal hemorrhage or development(or aggravation) of hepatic failure such as jaundice, ascites, or hepatic encephalopathy.	—

Secondary

Measure	Time frame
(1)Change of HBV DNA from pretreatment level, rate of the patients whose HBV DNA level decrease below 2.6 log copy/ml. (2)Clearance or seroconversion of HBeAg (3)ALT, albumin, prothrombin time (%), total bilirubin, platelet count, ascites (none, slight, moderate or much) (4)Emergence of entecavir-resistance	—

Countries

Japan

Contacts

Public ContactHaruhiko Kobashi

Okayama university hospital Department of gastroenterology and Hepatology

hkobashi@md.okayama-u.ac.jp086-235-7219

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026