UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017059
Receipt No. R000019781
Scientific Title Analysis of HCV DAA resistance mutations in HIV and HTLV-1 superinfection cases
Date of disclosure of the study information 2015/04/13
Last modified on 2016/07/05

* 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 Analysis of HCV DAA resistance mutations in HIV and HTLV-1 superinfection cases
Acronym Analysis of HCV DAA resistance mutations in HIV and HTLV-1 superinfection cases
Scientific Title Analysis of HCV DAA resistance mutations in HIV and HTLV-1 superinfection cases
Scientific Title:Acronym Analysis of HCV DAA resistance mutations in HIV and HTLV-1 superinfection cases
Region
Japan

Condition
Condition Patients HCV RNA is positive, and the HIV antibody or HTLV-1 antibody-positive,
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In superinfection cases of HIV or HTLV-1 and HCV, to analyze the HCV DAA resistant mutation frequency, primarily to clarify the temporal change of HCV DAA resistance mutations after treatment intervention in HIV infection.
Basic objectives2 Others
Basic objectives -Others Exploratory observational study
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes -The presence or absence of HCV DAA-resistant amino acid mutations
-The presence or absence of HCV NS3 area DAA-resistant amino acid mutations
-The presence or absence of HCV NS5A area DAA-resistant amino acid mutations
-The presence or absence of HCV NS5B area DAA-resistant amino acid mutations
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 -Patients was admitted to our hospital from January 2008 to December 2014
-Patients HCV RNA is positive, and the HIV antibody or HTLV-1 antibody-positive
-Cases save serum amount (500Micro milliliter) is stored
Key exclusion criteria -Patients already that against HCV, interventions such as IFN treatment has been carried out
-HCV RNA is a viral load low value is also positive, nucleotide sequence analysis is difficult cases
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Nakao
Organization Nagasaki University Hospital
Division name Gastroenterology and Hepatology
Zip code
Address 1-7-1 Sakamoto,Nagasaki
TEL 095-819-7481
Email kazuhiko@net.nagasaki-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Satoshi Miuma
Organization Nagasaki University Hospital
Division name Gastroenterology and Hepatology
Zip code
Address 1-7-1 Sakamoto,Nagasaki
TEL 095-819-7841
Homepage URL
Email miuma1002@gmail.com

Sponsor
Institute Nagasaki University Hospital
Institute
Department

Funding Source
Organization none
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
Email

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 04 Month 13 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 No longer recruiting
Date of protocol fixation
2015 Year 02 Month 17 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Exploratory observational clinical study

Management information
Registered date
2015 Year 04 Month 06 Day
Last modified on
2016 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019781

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.