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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000002580 |
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Date of registration:
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08/10/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Prospective validation for the usefulness of Genome-wide association study (GWAS) in predicting the effects of anti-viral therapy on chronic hepatitis C
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Scientific title:
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Prospective validation for the usefulness of Genome-wide association study (GWAS) in predicting the effects of anti-viral therapy on chronic hepatitis C - Chronic hepatitis C and GWAS |
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Date of first enrolment:
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2009/09/01 |
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Target sample size:
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250 |
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Recruitment status: |
Recruiting |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003145 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not applicable
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Countries of recruitment
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Japan
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Contacts
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Name:
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Naohiko Masaki, M.D. |
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Address:
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1-7-1 Kohnodai, Ichikawa, Chiba 272-8516, JAPAN
Japan |
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Telephone:
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81-47-372-3501 |
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Email:
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Affiliation:
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Kohnodai Hospital, International Medical Center of Japan Research Center for Hepatitis & Immunology |
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Name:
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Naohiko Masaki, M.D. |
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Address:
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1-7-1 Kohnodai, Ichikawa, Chiba 272-8516, JAPAN
Japan |
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Telephone:
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81-47-372-3501 |
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Email:
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nmasaki@imcjk2.hosp.go.jp |
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Affiliation:
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Kohnodai Hospital, International Medical Center of Japan Research Center for Hepatitis & Immunology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) Patients taking Sho-sai-koto(herbal medicine) 2) Autoimmune hepatitis 3) Patients with history of interstitial pneumonia 4) Patients with previous history of drug allergy against ribavirin, peginterferon alpha2a (Pegasys), peginterferon alpha2b (Pegintron), or other interferons 5) Patients with previous history of drug allergy against biological products such as vaccines 6) Liver cirrhosis, liver failure or hepatocellular carcinoma 7) Patients with the following laboratory data at the start of peginterferon and ribavirin combination therapy: WBC counts less than 4,000/microliter and Neutrophil counts less than 1,500/microliter; Platelets counts less than 90,000/microliter (peginterferon alpha2a) or 100,000/microliter(peginterferon alpha2b); Hemoglobin levelsless than 12g/dL 8) Women who are pregnant or have its possibility 9) Patients who refuse birth control, including male patients whose patners may have the chance to be pregnant 10) Patients whom the physicians in charge judge their enrollment inappropriate
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Chronic hepatitis C
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Intervention(s)
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Peginterferon alpha2a or alpha2b plus ribavirin for 48-72 weeks
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Primary Outcome(s)
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Relationship between targeted SNPs and virological response to peginterferon/ribavirin combination therapy
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Source(s) of Monetary Support
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International Medical Center of Japan
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/03/2012 |
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URL:
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