UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018554 |
|---|---|
| Receipt number | R000021469 |
| Scientific Title | Clinical Trial of Sofosbuvir/Ribavirin for HCV Genotype 2-infected Japanese Patients |
| Date of disclosure of the study information | 2015/08/05 |
| Last modified on | 2015/08/19 19:48:48 |
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Basic information
Public title
Clinical Trial of Sofosbuvir/Ribavirin for HCV Genotype 2-infected Japanese Patients
Acronym
Oral regimen for Genotype 2
Scientific Title
Clinical Trial of Sofosbuvir/Ribavirin for HCV Genotype 2-infected Japanese Patients
Scientific Title:Acronym
Oral regimen for Genotype 2
Region
| Japan |
Condition
Condition
Chronic hepatitis C (genotype 2)
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety
Basic objectives2
Others
Basic objectives -Others
metabolic markers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sustained virological response
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
HCV genotype 2 patients
Patients who satisfied the indication for sofosbuvir and ribavirin
Chronic hepatitis or compensated liver cirrhosis
Key exclusion criteria
Patients who have allergy to sofosbuvir or ribavirin
Patients with renal dysfunction
Patients with less than 12 g/dl hemoglobin
Patients expecting a child and have a possibility of pregnancy or who are breast-feeding
Patients taking contraindicated drug
Patients whom the doctor in attendance judged as inappropriate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Sato |
Organization
Gunma University
Division name
Department of Medicine and Molecular Science
Zip code
Address
3-39-22 Showa-machi, Maebashi, Gunma 371-8511, Japan.
TEL
027-220-8127
satoken@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Sato |
Organization
Gunma University
Division name
Department of Medicine and Molecular Science
Zip code
Address
3-39-22 Showa-machi, Maebashi, Gunma 371-8511, Japan.
TEL
027-220-8127
Homepage URL
satoken@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University and affiliated hospitals
Institute
Department
Personal name
Funding Source
Organization
Gunma University
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
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
| 2015 | Year | 08 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 06 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
sampling method
registration of patients in Gunma University hospital and its affiliated hospitals
research design
prospective cohort
exposure factor to be measured
antiviral effect
confounding factor to be adjusted
To minimaize the dropouts and recruit a wide age group as much as possible
Management information
Registered date
| 2015 | Year | 08 | Month | 05 | Day |
Last modified on
| 2015 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021469
