UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000000597
Receipt No. R000000726
Scientific Title 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.
Date of disclosure of the study information 2007/08/01
Last modified on 2007/02/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title 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.
Acronym Effect of entecavir treatment on cancer recurrence after a curative therapy of hepatocellular carcinoma complicated with chronic hepatitis B or cirrhosis.
Scientific Title 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.
Scientific Title:Acronym Effect of entecavir treatment on cancer recurrence after a curative therapy of hepatocellular carcinoma complicated with chronic hepatitis B or cirrhosis.
Region
Japan

Condition
Condition Chronic hepatitis B and cirrhosis after a curative treatment of hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to elucidate whether entecavir treatment prevents a cancer recurrence or not, in the patients with hepatocellular carcinoma complicated with chronic hepatitis B or cirrhosis after a curative therapy of the cancer, i.e., curative resection or radiofrequency ablation. Addingly, the long-term estimation of entecavir treatment will be made about the influence on serum HBV DNA level, serum ALT, hepatic reserve, drug resistance, survival, and safety.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes (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.
Key secondary outcomes (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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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. Afterwards, the doctor decides to continue or discontinue entecavir administration, dependent on HBV DNA level, ALT level and clinical conditions.
Interventions/Control_2 Control arm: The patients receive their therapy without anti viral medications such as entecavir, lamivudine, adefovir dipivoxil or interferon. In the case of development of cancer recurrence or hepatic failure, however, the doctor may start entecavir treatment.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
30 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key 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.
Key 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
Target sample size 170

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruhiko Kobashi
Organization Okayama university hospital
Division name Department of gastroenterology and hepatology
Zip code
Address 2-5-1 Shikata-cho, Okayama-city
TEL 086-235-7219
Email

Public contact
Name of contact person
1st name
Middle name
Last name Haruhiko Kobashi
Organization Okayama university hospital
Division name Department of gastroenterology and Hepatology
Zip code
Address 2-5-1 Shikata-cho, Okayama-city
TEL 086-235-7219
Homepage URL
Email hkobashi@md.okayama-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2007 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status
Date of protocol fixation
2006 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2006 Year 11 Month 01 Day
Last follow-up date
2013 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 02 Month 07 Day
Last modified on
2007 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000726

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.