UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000595 |
|---|---|
| Receipt number | 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 12:12:23 |
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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
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 | 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000723
