UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005502 |
|---|---|
| Receipt number | R000006110 |
| Scientific Title | IL28B gene polymorphism analysis and clinical research (effectiveness prediction of interferon treatment) |
| Date of disclosure of the study information | 2011/04/25 |
| Last modified on | 2018/09/20 15:42:30 |
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Basic information
Public title
IL28B gene polymorphism
analysis and clinical research (effectiveness prediction of interferon treatment)
Acronym
IL28B gene polymorphism
analysis and clinical research
Scientific Title
IL28B gene polymorphism
analysis and clinical research (effectiveness prediction of interferon treatment)
Scientific Title:Acronym
IL28B gene polymorphism
analysis and clinical research
Region
| Japan |
Condition
Condition
Chronic hepatitis c
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
When the Peginterferon plus ribavirin treatment to chronic hepatitis c patients, IL28B gene polymorphism is measured and the expected therapeutic gain is examined.
Basic objectives2
Others
Basic objectives -Others
Relationship between host factors and virological response to Peginterferon plus ribavirin treatment
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between IL28B gene polymorphism and virological response to Peginterferon plus ribavirin treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Peginterferon plus ribavirin for 48-72 weeks
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The following chronic hepatitis C patients with serogroup 1 and high viral load were eligible to enter the trial
1) From 18 years old or over
2)Chronic hepatitis C
3)The presence of the liver biopsy is not asked
4)HCV RNA>=5LogIU/mL
5)Platelet count >=90,000/micro L
6)WBC count>=3,000/micro L.
Neutrophil count >=1,500/micro L.
Hemoglobin concentration >=12g/dL.
7)The presence of the IFN treatment history is not asked
8)Patients who provided written informed consents to participate the study prior to enrollment
Key exclusion criteria
The following patients were excluded
1)Women of childbearing potential and pregnancy, lactating woman
2) allergic to ribavirin or nucleoside analogues
3)an uncontrollable heart trouble (myocardial infarction, heart failure, or arrhythmia)
4)hemoglobinopathy(thalassemia, sickle cell disease)
5) severe renal disease, Ccr <50ml/min
6) severe depression or psychosomatic disorders
7)severe liver disease
8) autoimmune hepatitis or HBV
9) drug allergy against interferon
10) Allergic to vaccine or biological preparations
11) Concomitant herbal medication of Sho-saikoto
12) history of interstitial pneumonia
13)Other conditions considered inappropriate by attending physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kouji Yakabi |
Organization
Saitama Medical Center
Division name
Division of Gastroenterology and Hepatology,internal Medicine
Zip code
Address
1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN
TEL
049-228-3400
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kouji Yakabi |
Organization
Saitama Medical Center
Division name
Division of Gastroenterology and Hepatology,internal Medicine
Zip code
Address
1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN
TEL
Homepage URL
Sponsor or person
Institute
Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
| 2011 | Year | 04 | Month | 25 | 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
| 2011 | Year | 03 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 25 | Day |
Last modified on
| 2018 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006110
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
