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 2023/04/07 12:44:28

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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

Email

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


Email

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

Email

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

2023 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

2023 Year 04 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015854


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name