UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000601 |
|---|---|
| Receipt number | R000000727 |
| Scientific Title | A multicenter open-label randomized controlled trial comparing continuing lamivudine treatment with switching from lamivudine to entecavir treatment for the patients with chronic hepatitis B or cirrhosis receiving lamivudine administration without lamivudine-resistant YMDD mutant virus. |
| Date of disclosure of the study information | 2007/08/01 |
| Last modified on | 2011/08/07 19:02:45 |
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Basic information
Public title
A multicenter open-label randomized controlled trial comparing continuing lamivudine treatment with switching from lamivudine to entecavir treatment for the patients with chronic hepatitis B or cirrhosis receiving lamivudine administration without lamivudine-resistant YMDD mutant virus.
Acronym
Switching from lamivudine to entecavir treatment: a randomized controlled trial
Scientific Title
A multicenter open-label randomized controlled trial comparing continuing lamivudine treatment with switching from lamivudine to entecavir treatment for the patients with chronic hepatitis B or cirrhosis receiving lamivudine administration without lamivudine-resistant YMDD mutant virus.
Scientific Title:Acronym
Switching from lamivudine to entecavir treatment: a randomized controlled trial
Region
| Japan |
Condition
Condition
Chronic hepatitis B or cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare continuation of lamivudine treatment with switching from lamivudine treatment to entecavir in the following viewpoints: (1)Development of virological breakthrough defined by more than 1 log copy/ml elevation of HBV DNA, and (2) development of entecavir-resistant mutant virus. The patients with chronic hepatitis B or cirrhosis who have been receiving lamivudine treatment for less than 2 years, and in whom lamivudine- resistant YMDD mutant virus has not been detected, are eligible.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
(1) Change of HBV DNA level and incidence rate of virological breakthrough, i.e., elevation of HBV DNA more than 1 log copy/ml.(2) HBeAg clearance rate(3) HBeAg seroconversion rate(4) Incidence of YMDD mutant virus(5) Incidence of entecavir-resistance related mutation
Key secondary outcomes
(1)ALT (2)s-Albumin (3)Prothrombin time 3(3)T.Bil (5)Platelets count (6) Ascites (7)Hepatic encephalopathy (8) Child-Pugh score (9) Development or recurrence of hepatocellular carcinoma (10) Precore mutant HBV (11) Core promoter mutant HBV
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lamivudine continuing group:Lamivudine (brand name: Zefix) administration 100mg per day orally is continued. If HBV DNA elevates above 4 log copy/ml or YMDD mutant HBV is detected by PCR thereafter, the study is discontinued, and the patients may be treated with additional administration of adefovir dipivoxil (brand name Hepsera) 10 mg per day orally, switching to entecavir treatment 1.0mg per day orally, or continuation of lamivudine administration, according to the decision of the doctor considering the condition of liver.
Interventions/Control_2
Switch-to-entecavir arm: Discontinue lamivudine treatment and switch to entecavir (brand name: Baraclude) administration in a daily dose of 0.5mg before retiring at night. If HBV DNA elevates over 4 log copy/ml or YMDD mutant HBV is detected by PCR afterwards, the patient drops out of the study and may be treated with combination therapy of lamivudine 100mg and adefovir dipivoxil 10mg per day orally, or switching to entecavir treatment in a daily dose of 1.0mg orally, considering the condition of liver.
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)Patients with chronic hepatitis B or cirrhosis who have been administered with lamivudine for less than 2 years. (2)Patients with positive HBsAg, normal ALT, and less than 2.6 log copy/ml HBV DNA. (3)YMDD mutant virus was not detected by PCR performed within 40 days before registration.
Key exclusion criteria
(1)The patients who has a history of an allergy against nucleos(t)ide analogues(2)The patients who have received interferon or other nucleoside analogues than lamivudine 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
120
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
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
Completed
Date of protocol fixation
| 2006 | Year | 12 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 02 | Month | 07 | 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=R000000727
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