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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000000595
Receipt No. R000000723
Scientific Title A multicenter open-label randomized controlled trial comparing interferon-entecavir sequential therapy with interferon monotherapy for chronic hepatitis B
Date of disclosure of the study information 2007/08/01
Last modified on 2007/02/07

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Basic information
Public title A multicenter open-label randomized controlled trial comparing interferon-entecavir sequential therapy with interferon monotherapy for chronic hepatitis B
Acronym Interferon-entecavir sequential therapy for chronic hepatitis B: a randomized controlled trial
Scientific Title A multicenter open-label randomized controlled trial comparing interferon-entecavir sequential therapy with interferon monotherapy for chronic hepatitis B
Scientific Title:Acronym Interferon-entecavir sequential therapy for chronic hepatitis B: a randomized controlled trial
Region
Japan

Condition
Condition chronic hepatitis B
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to clarify whether interferon-entecavir sequential therapy is superior to interferon monotherapy in lowering ALT, lowering HBV DNA, or inducing HBeAg seroconversion in the patients with chronic hepatitis B and positive HBeAg.
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 from baseline (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)Prothrombin time(%) (4)Total Bilirubin (5)Platelet count (6)Ascites (7)Hepatic encephalopathy (8)Child-Pugh score (9)Development of hepatocellular carcinoma (10)HBV precore mutation (11)HBV core promoter mutation

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 Interferon-entecavir sequential therapy arm:A single dose of 6 mega units of recombinant interferon-alpha2b (brand name: intron A) or natural IFN-alpha (brand name: Sumiferon) is administered subcutaneously 3 times per week for 24 weeks. Administration of entecavir (brand name: Baraclude), given orally every day in a daily dose of 0.5mg before retiring at night, is started at the first day of the 21st week and continued for 13 months. Afterwards, the course is observed without anti-viral medications until the end of the 24th month.
Interventions/Control_2 Interferon monotherapy arm: A single dose of 6 mega units of recombinant interferon-alpha2b (brand name: intron A) or natural IFN-alpha (brand name: Sumiferon) is administered subcutaneously 3 times per week for 24 weeks. Afterwards, the course is observed until the end of the 56th week without anti-viral medications. If HBeAg and HBV DNA is positive and ALT is abnormal at the 52th week, administration of entecavir (brand name: Baraclude), given orally every day in a daily dose of 0.5mg before retiring at night, is started at the 56th week. If not, the course observation 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
25 years-old <=
Age-upper limit
45 years-old >=
Gender Male and Female
Key inclusion criteria (1)The chronic hepatitis B patients with positive HBsAg, positive HBeAg, HBV DNA above 5.0 log copies/ml, abnormal ALT, and platelet counts over 140,000/microliter are eligible. (2)Liver cirrhosis is denied by physical examination, imaging and laboratory test. (3)Hepatocellular carcinoma is not detected by imaging.
Key exclusion criteria (1)The patients who have an allergy against interferons (2)The patients who have an allergy against nucleos(t)ide analogues (3)The patients who have received interferon or nucleoside analogue within 6 months before registration (4)Pregnant women, or women who are nursing (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 with a severe mental disease such as depression, a suicide consideration, or a suicide project, or the past history of such conditions (8)The patients with liver cirrhosis or severe hepatic diseases (9)The patients having a past history of cerebral hemorrhage or cerebral infarction (10)The patients with other liver diseases such as autoimmune hepatitis, primary biliary cirrhosis, alcoholic liver injury, or chronic hepatitis C (11)The patients having non-liver autoimmune diseases, such as rheumatoid arthritis (12)The patients who are prescribed with Shoh-saiko-toh (13)The patients who were judged inappropriate for the study by the doctor.
Target sample size 170

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 11 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 07 Day
Last modified on
2007 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000723

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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