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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016633
Receipt No. R000019310
Scientific Title The analysis of the factors related to efficacy of asunaprevir and daclatasvir hydrochloride for hepatitis C-related liver disease
Date of disclosure of the study information 2015/02/26
Last modified on 2015/02/25

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Basic information
Public title The analysis of the factors related to efficacy of asunaprevir and daclatasvir hydrochloride for hepatitis C-related liver disease
Acronym antiviral therapy with asunaprevir and daclatasvir hydrochloride
Scientific Title The analysis of the factors related to efficacy of asunaprevir and daclatasvir hydrochloride for hepatitis C-related liver disease
Scientific Title:Acronym antiviral therapy with asunaprevir and daclatasvir hydrochloride
Region
Japan

Condition
Condition HCV-related liver diseases
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 antiviral effect (sustained viral responce rate 24 weeks after treatment)
Basic objectives2 Others
Basic objectives -Others 1)Analysis of the factors related to the efficacy of antiviral therapy
2)Analysis of the effect of antiviral therapy of glucose/lipid metabolism, immune functions, hepatocarcinogenesis and gene expression
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes antiviral effect (sustained viral responce rate 24 weeks after treatment)
Key secondary outcomes 1)analysis of HCV sequcenc of core, NS3 protease, and NS5A
2)analysis of expression of non-coding RNA in liver and blood
3)analysis of gene expression of peripheral lympocytes
4)analysis of gene expression of liver
5)analisis of liver stiffness by fibroscan
6)analysis of cytokines in bood
7)analysis of the markers for glucose and lipid metabolism
8)analysis of the function of T lymphocyte related to hepatoma
9)rate of hepatocarcinogenesis and recurrence of hepatoma after antiviral therapy

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Asunaprevir Capsule 100 mg twice a day
Daclatasvir hydrochloride 60 mg tablet once a day
24 weeks
oral administration
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1)Patients with CH-C or those with compensated LC-C
2)HCV genotype 1/serotype 1
3)Patients who are treatment-naiveve and ineligible for, or intolerable to, interferon-based therapy
Ineligible patients refer to those who could not receive interferon-based therapy due to severe psychiatric disorder, interstitial pneumonia, or autoimmune disease.
Intolerable patients refer to those who had previously received interferon but discontinued the drug during the treatment due to adverse reactions
4)Patients who have failed to respond to interferon-based therapy
5)Patients aged >/= 20 years and < 80 years at the time of informed consent
6)Patients who have voluntarily provided written informed consent after fully understanding the information given about participation in the study.
Key exclusion criteria 1)Patients with a history of hypersensitivity to any ingredient contained in asunaprevir and daclatasvir hydrochloride [Contraindications in the package insert]
2)Pregnant women, women suspected of being pregnant, or lactating women [Contraindications in the package insert]
3)Patients who are receiving any of the following drugs [Contraindications for coadministration in the package insert]
Rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital, systemic dexamethasone, food products containing St. John's wort, azole antifungal agents, clarithromycin, erythromycin, diltiazem, verapamil hydrochloride, drug products containing cobicistat, HIV protease inhibitor, modafinil, non-nucleoside reverse transcriptase inhibitor, bosentan hydrate, cyclosporine, flecainide, propafenone
4)Patients with moderate (Child-Pugh Class B or C) hepatic impairment or those with decompensated liver disease (poorly controlled ascites or hepatic encephalopathy, T.Bil 3.0 mg/dl or above) [Contraindications in the package insert]
5)Patients who are considered by the investigators as inappropriate to be study patients [established for the sake of patient safety]. Patients who meet any of the following criteria will be ineligible for inclusion in the study
6)Patients who received treatment of liver cancer within the past 6 months
7)Patients who are considered by the investigators/subinvestigators as inappropriate to be subjects.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuro Shimakami
Organization Kanazawa University Hospital
Division name Department of Gastroenterology
Zip code
Address Takaramachi 13-1, Kanazawa, Ishikawa
TEL 076-265-2235
Email shimakami@m-kanazawa.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuro Shimakami
Organization Kanazawa University Hospital
Division name Department of Gastroenterology
Zip code
Address Takaramachi 13-1, Kanazawa, Ishikawa
TEL 076-265-2235
Homepage URL
Email shimakami@m-kanazawa.jp

Sponsor
Institute Kanazawa University
Institute
Department

Funding Source
Organization Kanazawa University
Organization
Division
Category of Funding Organization
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 黒部市民病院(富山県)
富山労災病院(富山県)
厚生連滑川病院(富山県)
富山県立中央病院(富山県)
おぎの内科医院(富山県)   
富山市民病院(富山県)         
厚生連高岡病院(富山県)      
市立砺波総合病院(富山県)      
公立能登総合病院(石川県)    
市立輪島病院(石川県) 
恵寿総合病院(石川県) 
公立羽咋病院(石川県) 
金沢医療センター(石川県) 
金沢市立病院(石川県) 
金沢赤十字病院(石川県)             
石川県済生会金沢病院(石川県)         
公立松任石川中央病院(石川県)          
金沢聖霊病院(石川県)    
能美市立病院(石川県)  
金沢有松病院(石川県) 
やわたメディカルセンター(石川県)  
河北中央病院(石川県) 
小松ソフィア病院(石川県)  
福井県済生会病院(福井県)
市立敦賀病院(福井県)
石川県立中央病院(石川県)
宇出津総合病院(石川県)
福井大学病院(福井県)
福井県立病院(福井県)

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 26 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
2014 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 01 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
2019 Year 09 Month 30 Day
Date trial data considered complete
2019 Year 09 Month 30 Day
Date analysis concluded
2020 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2015 Year 02 Month 25 Day
Last modified on
2015 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019310

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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