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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000000602
Receipt No. R000000728
Scientific Title A multicenter randomized controlled trial comparing the efficacy and safety of lamivudine-adefovir combinational therapy with adefovir monotherapy for chronic hepatitis B and cirrhosis with lamivudine-resistance.
Date of disclosure of the study information 2007/08/01
Last modified on 2007/02/08

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Basic information
Public title A multicenter randomized controlled trial comparing the efficacy and safety of lamivudine-adefovir combinational therapy with adefovir monotherapy for chronic hepatitis B and cirrhosis with lamivudine-resistance.
Acronym Adefovir monotherapy for lamivudine-resistant chronic hepatitis B and cirrhosis
Scientific Title A multicenter randomized controlled trial comparing the efficacy and safety of lamivudine-adefovir combinational therapy with adefovir monotherapy for chronic hepatitis B and cirrhosis with lamivudine-resistance.
Scientific Title:Acronym Adefovir monotherapy for lamivudine-resistant chronic hepatitis B and cirrhosis
Region
Japan

Condition
Condition Chronic hepatitis B or cirrhosis with lamivudine-resistance
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this randomized controlled study is to examine the effectiveness and safety of adefovir monotherapy switched from lamivudine-adefovir combinational therapy for chronic hepatitis B or cirrhosis with lamivudine-resistance and sustained normal ALT and low HBV DNA load by lamivudine-adefovir combination therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes (1) Change of HBV DNA (2) Rate of the patients whose HBV DNA elevates over 2.6 log copies/ml (3) HBeAg clearance (4) HBeAg seroconversion
Key secondary outcomes (1) ALT (2)Albumin (3)T.Bil (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(12) YMDD mutation (13) HBV mutation related with Adefovir-resistance

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
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 Adefovir-monotherapy arm: Switch from Lamivudine-Adefovir combinational therapy to Adefovir monotherapy, i.e., oral administration of Adefovir dipivoxil (brand name: Hepsera) in a daily dose of 10mg. If HBV DNA re-elevates or ALT re-elevates above two-fold of baseline afterwards, Lamivudine (brand name: Zefix) administration in a daily dose of 100 mg is re-started.
Interventions/Control_2 Lamivudine-adefovir combinational therapy arm: Combinational therapy of Lamivudine (brand name: Zefix) 100 mg per day and Adefovir dipivoxil (brand name: Hepsera) 10mg per day is continued.
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.(2)The patients who are receiving co-administration of adefovir dipivoxil with lamivudine because of lamivudine-resistance (3)HBV DNA level is under 2.6 log copy/ml for more than 3 months before registration.(4)Hepatocellular carcinoma that needs medical treatment is not detected.
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 within 6 months before registration.(3) Pregnant women, or women who are nursing(4) The patients with an uncontrollable heart trouble (myocardial infarction, heart failure, or arrhythmia)(5) The patients with severe chronic renal failure or chronic respiratory failure(6) The patients with other chronic liver disease, such as autoimmune hepatitis, primary biliary cirrhosis, alcoholic hepatitis, or chronic hepatitis C.(7) The patients who were thought to be inapproriate for this study by the doctor
Target sample size 100

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 12 Month 01 Day
Last follow-up date
2011 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 08 Day
Last modified on
2007 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000728

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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