UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023271 |
|---|---|
| Receipt number | R000026819 |
| Scientific Title | Post marketing study of sofosbuvir and ledipasvir for genotype 1 hepatitis C virus infection |
| Date of disclosure of the study information | 2016/07/21 |
| Last modified on | 2019/01/23 22:52:49 |
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Basic information
Public title
Post marketing study of sofosbuvir and ledipasvir for genotype 1 hepatitis C virus infection
Acronym
Sofosbuvir and ledipasvir for genotype 1 HCV
Scientific Title
Post marketing study of sofosbuvir and ledipasvir for genotype 1 hepatitis C virus infection
Scientific Title:Acronym
Sofosbuvir and ledipasvir for genotype 1 HCV
Region
| Japan |
Condition
Condition
Hepatitis virus infection
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate safety, efficacy and factors influencing on treatment response of sofosbuvir and ledipasvir
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sustained virological response at 12 weekes after the end of therapy
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
Patients with genotype 1 HCV infection
Key exclusion criteria
1) pregnant woman
2) decompensated cirrhosis
3) severe renal dysfunction (<eGFR30)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Tamai |
Organization
Wakayama Medical University
Division name
Second department of internal medicine
Zip code
Address
811-1, Kimidera, Wakayama City
TEL
073-447-2300
tamahide@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideyuki Tamai |
Organization
Wakayama Medical University
Division name
Second department of internal medicine
Zip code
Address
811-1, Kimidera, Wakayama City
TEL
073-447-2300
Homepage URL
tamahide@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical 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
| 2016 | Year | 07 | Month | 21 | 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
| 2015 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 29 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
During therapy, quantitative HCV-RNA, biochemical analyses including blood counts, serumalanine aminotransferase (ALT),aspartate aminotransferase (AST), liver and renal functional tests were performed every 4
weeks up to 24weeks after the end of therapy.
Management information
Registered date
| 2016 | Year | 07 | Month | 21 | Day |
Last modified on
| 2019 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026819
