UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016633 |
|---|---|
| Receipt number | 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 20:04:37 |
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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
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
shimakami@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019310
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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