UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013585 |
|---|---|
| Receipt number | R000015854 |
| Scientific Title | Prospective study on anti-islet autoantibody and glucose tolerance in chronic hepatitis C patients treated with interferon. |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2025/10/08 09:19:07 |
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Basic information
Public title
Prospective study on anti-islet autoantibody and glucose tolerance in chronic hepatitis C patients treated with interferon.
Acronym
Anti-islet autoantibody and glucose tolerance in chronic hepatitis C patients treated with interferon.
Scientific Title
Prospective study on anti-islet autoantibody and glucose tolerance in chronic hepatitis C patients treated with interferon.
Scientific Title:Acronym
Anti-islet autoantibody and glucose tolerance in chronic hepatitis C patients treated with interferon.
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the development of anti-islet autoantibodies and the changes in glucose tolerance in chronic hepatitis C patients treated with interferon.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive rate of anti-islet autoantibodies.
Key secondary outcomes
Changes in glucose tolerance.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are indicated and eligible for interferon alpha treatment; a positive test for anti-HCV antibody and HCV RNA assessed by a quantitative assay, and entry neutrophil counts, platelet counts, and hemoglobin levels of at or above 1,500/microL, 100,000/microL, and 12 g/dL, respectively.
Key exclusion criteria
Patients with the followings: other viral infections such as infection with the hepatitis B virus or human immunodeficiency virus; any other cause of liver disease, e.g., autoimmune hepatitis, primary biliary cirrhosis, drug-induced liver disease, and excessive daily intake of alcohol (>40 g per day over the period of more than 5 years); relevant disorders, including decompensated liver disease, cirrhosis, hepatocellular carcinoma, and other malignant neoplastic diseases; concomitant use of immunosuppressive or herbal medications (e.g. Sho-saiko-to); current use of intravenous drugs; poorly controlled diabetes mellitus, hypertension, cardiovascular disease, chronic renal failure, or creatinine clearance values <50 mL/min.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuhide |
| Middle name | |
| Last name | Yamamoto |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-7216
kazuhide@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Iwasaki |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-7219
Homepage URL
yiwasaki@cc.okayama-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Okayama University Hospital
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
Okayama University Hospital
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
Tel
086-235-7219
yiwasaki@okayama-u.ac.jp
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
| 2014 | Year | 04 | 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
78
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
No longer recruiting
Date of protocol fixation
| 2006 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2006 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2006 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study
Consecutive cases
Management information
Registered date
| 2014 | Year | 03 | Month | 31 | Day |
Last modified on
| 2025 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015854
