UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017560 |
|---|---|
| Receipt number | R000020346 |
| Scientific Title | Study of the effectiveness of the response and interferon combination therapy for ribavirin monotherapy for chronic hepatitis C |
| Date of disclosure of the study information | 2015/05/14 |
| Last modified on | 2015/05/14 13:23:02 |
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Basic information
Public title
Study of the effectiveness of the response and interferon combination therapy for ribavirin monotherapy for chronic hepatitis C
Acronym
Study of the response of ribavirin monotherapy in patients with chronic hepatitis C
Scientific Title
Study of the effectiveness of the response and interferon combination therapy for ribavirin monotherapy for chronic hepatitis C
Scientific Title:Acronym
Study of the response of ribavirin monotherapy in patients with chronic hepatitis C
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 study patients' and viral response during ribavirin monotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The effects of the combination therapy with interferon preceeded with ribavirin monotherapy.
Key secondary outcomes
Adverse events of ribavirin monotherapy.
Base
Study type
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
ribavirin monotherapy for 4 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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Chronic hepatitis patients with anti-HCV and HCV-RNA positive
Key exclusion criteria
We excluded:
1)HBs antibody positive
2))HIV antibody positive
3)decompensated liver chirrosis
4)severe herat failuer
5)severe kideny dysfunction
6)ineligible to interferon therapy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuhei Hige |
Organization
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Division name
Department of 3rd Gastroenterolgy
Zip code
Address
North 3 Jo, East 8-5, Chuo-Ku, Sapporo
TEL
011-261-5331
shuhei.hige@ja-hokkaidoukouseiren.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoe Kobayashi |
Organization
Hokkaido University
Division name
Department of Gastroenterology
Zip code
Address
North 17 jo, West 5 chome, Kita-Ku, Sapporo
TEL
011-706-7429
Homepage URL
tk990063@yahoo.co.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University, Department of Gastroenteroly
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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
008-0046
Org. issuing International ID_1
Hokkaido University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2008 | Year | 09 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 14 | Day |
Last modified on
| 2015 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020346
