UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018857 |
|---|---|
| Receipt number | R000021811 |
| Scientific Title | Assessment of variants associated with resistance in NS3, NS5A and NS5B region in genotype 1b HCV infected patients |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2020/09/29 13:24:19 |
* 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
Assessment of variants associated with resistance in NS3, NS5A and NS5B region in genotype 1b HCV infected patients
Acronym
Assessment of RAVs
Scientific Title
Assessment of variants associated with resistance in NS3, NS5A and NS5B region in genotype 1b HCV infected patients
Scientific Title:Acronym
Assessment of RAVs
Region
| Japan |
Condition
Condition
patients infected with genotype 1 HCV
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To improve the therapeutic effects of antiviral therapy in chronic hepatitis C genotype 1 by evaluated the kinetics of RAVs in NS3, NS5A and NS5B region of HCV.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the efficacy of antiviral therapy at post-treatment 12 and 24 weeks
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 1 infected patients who recieve anti-viral therapy such as combination therapy with daclatasvis/asunaprevir, sofosbuvir/ledipasvir and ombitasvir/paritaprevir/ritonavir
Key exclusion criteria
patients infected with HCV other than genotype 1
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Satoch |
| Middle name | |
| Last name | Mochida |
Organization
Saitama Medical University
Division name
Department of Gastroenterology & Hepatology
Zip code
3500495
Address
38 Morohongo, Moroyama-Machi, Iruma-Gun, Saitama
TEL
049-276-1198
smochida@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihito |
| Middle name | |
| Last name | Uchida |
Organization
Saitama Medical University
Division name
Department of Gastroenterology & Hepatology
Zip code
3500495
Address
38 Morohongo, Moroyama-Machi, Iruma-Gun, Saitama
TEL
049-276-1198
Homepage URL
y_uchida@saitama-med.ac.jp
Sponsor or person
Institute
Department of Gastroenterology & Hepatology,
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan agency for medical research and development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of Saitama Medical University Hospital
Address
38 Morohongo, Moroyama-cho, Iruma-gun, Saitama,
Tel
0492761354
hirb@saitama-med.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We collect patients' serum samples at start and 1, 2 and 4 weeks of treatment and evaluate the variants associated with resistance in NS3, NS5A and NS5B region. When viral RNA are not negative at 4 weeks of treatment, we continue the serum sampling and evaluation every 2 weeks. In the cases that viral RNA are negative at 4 weeks of treatment, sera are collected when viral RNA are positive during anti viral therapy.
Management information
Registered date
| 2015 | Year | 08 | Month | 30 | Day |
Last modified on
| 2020 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021811
