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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019391
Receipt No. R000022430
Scientific Title Study of drug resistance virus in oral agents to genotype 1 chronic hepatitis
Date of disclosure of the study information 2015/10/20
Last modified on 2015/10/18

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Basic information
Public title Study of drug resistance virus in oral agents to genotype 1 chronic hepatitis
Acronym Study of drug resistance virus to genotype 1 chronic hepatitis
Scientific Title Study of drug resistance virus in oral agents to genotype 1 chronic hepatitis
Scientific Title:Acronym Study of drug resistance virus to genotype 1 chronic hepatitis
Region
Japan

Condition
Condition Genotype 1 chronic hepatitis C
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Recently, direct-acting antiviral agents (DAAs) which specifically effect for HCV virus is developed. Drug resistance virus influence the efficacy of DAAs. The first generation treatment of Daclatasvir/Asunaprevir were available from 2014 in Japan. Drug resistance virus was deeply associated with the efficacy of treatment in Daclatasvir/Asunaprevir treatment. Drug resistance virus is expected to influence the outcome of second generation treatments (ledipasvir/sofosbuvir or ombitasvir/paritaprevir/ritonavir etc.). But it has not been reported on the real world clinical setting in Japan. It is important to clarify the association between second generation DAAs treatments and drug resistance virus.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The dynamic state of drug resistance virus was studied before pre-treatment and viral breakthrough.
Key secondary outcomes HCV RNA levels were assessed at pre treatment and 2, 4, 8, 12weeks or end of treatment (EOT) and at 12 and 24 weeks after completion of treatment, and routine biochemical and hematological tests were also performed.

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
85 years-old >=
Gender Male and Female
Key inclusion criteria Eligible patients were 20 to 85years of chronic HCV genotype 1 infection. Patients received the second generation oral agents(ledipasvir/sofosbuvir or ombitasvir/paritaprevir/ritonavir etc.) for 12 weeks.
Key exclusion criteria Patients with decompensated liver disease, coinfection with hepatitis B virus or human immunodeficiency virus, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis or Wilson's disease were excluded. Patients with uncontrollable hypertension or diabetes mellitus and those with a history of alcohol abuse were also excluded.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshio Sumida
Organization Kyoto Prefectural University of Medicine
Division name Department of Molecular Gastroenterology and Hepatology
Zip code
Address 465, Kajii-chou, Kawaramachi, Kamigyou-ku,Kyoto 602-0841, Japan
TEL 075-251-5519
Email sumida@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Fujii
Organization Kyoto Prefectural University of Medicine
Division name Department of Molecular Gastroenterology and Hepatology
Zip code
Address 465, Kajii-chou, Kawaramachi, Kamigyou-ku,Kyoto 602-0841, Japan
TEL 075-251-5519
Homepage URL http://www.f.kpu-m.ac.jp/k/syokanai/
Email fuhideki@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine, Department of Molecular Gastroenterology and Hepatology
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 10 Month 20 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 Enrolling by invitation
Date of protocol fixation
2015 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective study.Target sample size are 200 cases. We treat the genotype 1 chronic hepatitis with the second generation DAAs as followed by the manufacturer's recommendations. This study have no blind trial or randomization. Patients who are on an outpatients of Kyoto Prefectural University of Medicine or affiliated hospitals in Kinki area and agree with the clinical research are candidate. The dynamic state of drug resistance virus was studied before pre-treatment and viral breakthrough. HCV RNA levels were assessed at pre treatment and 2, 4, 8, 12weeks or end of treatment (EOT) and at 12 and 24 weeks after completion of treatment. Clinical history, clinical background, routine biochemical, hematological tests, were also accumulated and performed.

Management information
Registered date
2015 Year 10 Month 18 Day
Last modified on
2015 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022430

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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