UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000594 |
|---|---|
| Receipt number | R000000722 |
| Scientific Title | A multicenter open-label trial of entecavir treatment for chronic hepatitis B and cirrhosis: Effectiveness and safety |
| Date of disclosure of the study information | 2007/08/01 |
| Last modified on | 2011/08/07 18:57:46 |
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Basic information
Public title
A multicenter open-label trial of entecavir treatment for chronic hepatitis B and cirrhosis: Effectiveness and safety
Acronym
Entecavir open trial of chronic hepatitis B and cirrhosis
Scientific Title
A multicenter open-label trial of entecavir treatment for chronic hepatitis B and cirrhosis: Effectiveness and safety
Scientific Title:Acronym
Entecavir open trial of chronic hepatitis B and cirrhosis
Region
| Japan |
Condition
Condition
Chronic hepatitis B and cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this trial is to evaluate anti-virus effect, improvement of ALT and hepatic reserve, emergence rate of drug-resistance, incidence of liver cancer, and safety profile in entecavir treatment for chronic hepatitis B or cirrhosis by prospective observation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
(1)Change of HBV DNA (2)Fall of HBV DNA to less than 2.6 log copies/ml (3)HBeAg clearance (4)HBeAg seroconversion (5)Emergence of entecavir-resistance
Key secondary outcomes
(1)ALT (2)Albumin (3)T.Bilirubin (4)Prothrombin time (%) (5)Platelet count (6)Ascites (7)Hepatic encephalopathy (8)Develpoment of hepatocellular carcinoma(9)HBV precore mutation (10)HBV core promoter mutation (11)Child-Pugh score
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Entecavir (brand name: Baraclude) is administered orally in a daily dose of 0.5 mg before retiring at night.
Interventions/Control_2
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
Chronic hepatitis B or cirrhosis with positive HBsAg, abnormal ALT, and serum HBV DNA over 5 Log copies/ml
Key exclusion criteria
(1) The patient who has an allergy against nucleios(t)ide analogues. (2) Pregnant women, or the women who are nursing.(3) The patients with an uncontrollable heart trouble (myocardial infarction, heart failure, or arrhythmia).(4) The patients with serious chronic renal failure, or chronic respiratory failure.(5) The patient who was thought to be inappropriate for the study by the doctor.
Target sample size
65
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Kobashi H, Miyake Y, Ikeda F, Yasunaka T, Nishino K, Moriya A, Kubota J, Nakamura S, Takaki A, Nouso K, Yamada G, Yamamoto K.
Long-term outcome and hepatocellular carcinoma development in chronic hepatitis B or cirrhosis patients after nucleoside analog treatment with entecavir or lamivudine.
Hepatology Research 2011 May;41(5):405-16.
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
Completed
Date of protocol fixation
| 2006 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 12 | Month | 01 | Day |
Other
Other related information
Aim: We conducted this prospective study to elucidate the long-term outcome and incidence of hepatocellular carcinoma (HCC) development after nucleos(t)ide analog (NA) treatment in patients with chronic hepatitis B (CHB) or cirrhosis. Methods: CHB or cirrhosis patients without past NA treatment or HCC were started on entecavir (ETV) or lamivudine (LVD), and prospectively followed up with monthly blood tests, and with abdominal imaging every 6months in CHB and every 3months in cirrhosis patients. Results: A total of 256 subjects with CHB or cirrhosis received ETV or LVD for 4.25 years (range: 0.4-10.0). After NA treatment, serum HBV DNA, alanine aminotransferase and alpha-fetoprotein (AFP) dropped significantly, along with significant increases in serum albumin and prothrombin time. Drug-resistance developed in 60 cases in the LVD group and in only one case in the ETV group. HCC developed in 35 patients, and the incidence at years 1, 3, 5, 7 and 10 was significantly higher in patients with cirrhosis (8.1%, 17.5%, 43.2%, 46.7% and 53.4%, respectively) than chronic hepatitis (1.6%, 3.5%, 3.5%, 7.1% and 29.6%, respectively), with no difference between ETV and LVD. After NA treatment, the sensitivity/specificity for HCC of AFP and des-gamma-carboxy prothrombin (DCP) was 45.7%/97.3% and 33.3%/96.2%, respectively, with the specificity of AFP being higher than at baseline (64.4%), at the cut-off of 10 ng/mL. Conclusion: NA exerted a long-term efficacy and improved hepatic reservation in CHB and cirrhosis. After NA treatment, AFP dropped to lower than 10 ng/mL with marked elevation of specificity, leading to an earlier detection of HCC.
Management information
Registered date
| 2007 | Year | 02 | Month | 06 | Day |
Last modified on
| 2011 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000722
