UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002580 |
|---|---|
| Receipt number | R000003145 |
| Scientific Title | Prospective validation for the usefulness of Genome-wide association study (GWAS) in predicting the effects of anti-viral therapy on chronic hepatitis C |
| Date of disclosure of the study information | 2009/10/08 |
| Last modified on | 2009/10/03 14:37:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective validation for the usefulness of Genome-wide association study (GWAS) in predicting the effects of anti-viral therapy on chronic hepatitis C
Acronym
Chronic hepatitis C and GWAS
Scientific Title
Prospective validation for the usefulness of Genome-wide association study (GWAS) in predicting the effects of anti-viral therapy on chronic hepatitis C
Scientific Title:Acronym
Chronic hepatitis C and GWAS
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate predictability of therapeutic outcome by prospectively measuring SNPs, which were recently identified by coworkers, in patients with chronic hepatitis C treated by peginterferon/ribavirin combination therapy
Basic objectives2
Others
Basic objectives -Others
Relationship between targeted SNPs and virological response to peginterferon/ribavirin combination therapy
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between targeted SNPs and virological response to peginterferon/ribavirin combination therapy
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 alpha2a or alpha2b 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic hepatitis C of genotype 1 and high viral load who newly start peginterferon and ribavirin combination therapy
Key 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
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naohiko Masaki, M.D. |
Organization
Kohnodai Hospital, International Medical Center of Japan
Division name
Research Center for Hepatitis & Immunology
Zip code
Address
1-7-1 Kohnodai, Ichikawa, Chiba 272-8516, JAPAN
TEL
81-47-372-3501
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naohiko Masaki, M.D. |
Organization
Kohnodai Hospital, International Medical Center of Japan
Division name
Research Center for Hepatitis & Immunology
Zip code
Address
1-7-1 Kohnodai, Ichikawa, Chiba 272-8516, JAPAN
TEL
81-47-372-3501
Homepage URL
nmasaki@imcjk2.hosp.go.jp
Sponsor or person
Institute
Research Center for Hepatitis & Immunology, Kohnodai Hospital, International Medical Center of Japan
Institute
Department
Personal name
Funding Source
Organization
International Medical Center of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
国立国際医療センター戸山病院（東京都）、国立国際医療センター国府台病院（千葉県）、東京大学病院（東京都）、国立病院機構長崎医療センター（長崎県）、武蔵野赤十字病院（東京都）、名古屋市立大学病院（愛知県）、兵庫医科大学病院（兵庫県）、川崎医科大学病院（岡山県）、順天堂大学病院（東京都）、新潟大学病院（新潟県）、山梨大学病院（山梨県）、愛知医科大学病院（愛知県）、国立病院機構大阪医療センター（大阪府）、国立病院機構高崎病院（群馬県）、社会保険中央総合病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 10 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 09 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | 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
| 2009 | Year | 10 | Month | 03 | Day |
Last modified on
| 2009 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003145
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
