UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016288 |
|---|---|
| Receipt number | R000018897 |
| Scientific Title | Antiviral therapy with direct acting anti-virals in hepatitis C patients. |
| Date of disclosure of the study information | 2015/01/20 |
| Last modified on | 2023/01/25 15:37:58 |
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Basic information
Public title
Antiviral therapy with direct acting anti-virals in hepatitis C patients.
Acronym
Antiviral therapy with direct acting anti-virals in hepatitis C patients.
Scientific Title
Antiviral therapy with direct acting anti-virals in hepatitis C patients.
Scientific Title:Acronym
Antiviral therapy with direct acting anti-virals in hepatitis C patients.
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy and safety of antiviral therapy with direct acting antivirals for chronic hepatitis C.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy and safety of antiviral therapy with direct acting antivirals for chronic hepatitis C.
Key secondary outcomes
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
1. Chronic hepatitis C
2. Hepatitis C patients treated with direct acting antivirals
3. 20 years old and over
4. Written informed consent for participation in this study is obtained
Key exclusion criteria
without abilty to understand informed consent
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Ide |
Organization
Department of Medicine,
Kurume University School of Medicine
Division name
Division of Gastroenterology
Zip code
830-0011
Address
Ashimachi 67,Kurume,Fukuoka,Japan
TEL
0942-31-7561
ide@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Ide |
Organization
Department of Medicine, Kurume University School of Medicine
Division name
Division of Gastroenterology
Zip code
830-0011
Address
Ashimachi 67,Kurume,Fukuoka,Japan
TEL
0942-31-7561
Homepage URL
ide@med.kurume-u.ac.jp
Sponsor or person
Institute
Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine
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
Kurume University
Address
Asahimachi67, Kurumeshi,Fukuoka,Japan
Tel
0942-35-3311
ide@med.kurume-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
久留米大学医療センター(福岡県)、産業医科大学医学部 第3内科学(福岡県)、佐賀大学医学部 肝臓･糖尿病･内分泌内科(佐賀県）、朝倉医師会病院(福岡県)、大牟田市立病院(福岡県)、八女公立総合病院(福岡県)、二日市済生会病院(福岡県)、筑後市立病院(福岡県)、聖マリア病院(福岡県)、久留米総合病院(福岡県)、佐賀中部病院(佐賀県）、柳川病院(福岡県)、熊本セントラル病院（熊本県）、社会保険田川病院(福岡県)、長田病院(福岡県)、戸畑共立病院(福岡県)、ふじおか病院(佐賀県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 20 | 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
| 2014 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will observe the efficacy and safety of anti-viral therapy with direct acting antivirals for hepatitis C in Kurume University and a joint research institution, and analyze the factors of the efficacy and safety.
Management information
Registered date
| 2015 | Year | 01 | Month | 20 | Day |
Last modified on
| 2023 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018897
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
