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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000601
Receipt No. 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

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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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000727

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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