UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000597 |
|---|---|
| Receipt number | 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 13:18:47 |
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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, naïve 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
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
hkobashi@md.okayama-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000726
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