UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000602 |
|---|---|
| Receipt number | 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 15:03:34 |
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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
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 | 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000728
