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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020911
Receipt No. R000024127
Scientific Title The effects of IFN-free 2D regimen (ombitasvir/paritaprevir/ritonavir) on host immune responses against hepatitis C virus
Date of disclosure of the study information 2016/02/06
Last modified on 2016/03/09

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Basic information
Public title The effects of IFN-free 2D regimen (ombitasvir/paritaprevir/ritonavir) on host immune responses against hepatitis C virus
Acronym The effect of HCV elimination on host immune responces against hepatitis C virus
Scientific Title The effects of IFN-free 2D regimen (ombitasvir/paritaprevir/ritonavir) on host immune responses against hepatitis C virus
Scientific Title:Acronym The effect of HCV elimination on host immune responces against hepatitis C virus
Region
Japan

Condition
Condition Chronic liver diseases due to infection with genoetype1/serotype 1 hepatitis C virus
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To investigate whether the AbbVie's 2D therapy has the possibility to restore host immune responses against HCV and to understand the mechanism, we analyze gene expression profiles in peripheral blood mononuclear cells and immunological effects during and after the treatment.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes This is an exploratory study to investigate whether 2D therapy with PTV/r/OBV restores host immune response against HCV via comparing changes in gene expression profiles between patients who achieve SVR vs. patients who do not achieve SVR.
Key secondary outcomes 1)To further explore changes in immune response via analyzing the effect on cytokine changes in peripheral blood and analyzing effect at the molecular level
2)Predicion of hepatoma by using age, sex, fibrotic markers (APRI, FIB-4, and Fibro test etc.), fibrotic scoring, and cellular immunity
3)To explore host or viral factors contributing to SVR

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Viekirax, once per day, 2 tablets per once (Paritaprevir 150mg,Ombitasvir 25mg, ritonavir 100mg), for 12 weeks
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 chronic hapatitis or compensated liver cirrhosis due to HCV infection, and treated by Viekirax
2) HCV is genotype1 or serotype 1
Key exclusion criteria 1)Patiens who have had allergy to any ingredients of Viekirax
2)Patienes who are taking any medicines which are on the lists of contraindication for coadministration in the pharmaceutical reference of Viekirax
3)Patients who show moderate-severe hepatic dysfunction (Child-Pugh classification B or C)
4)Patients who have been treated for hepatoma within 6 months before taking Viekrax
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mizukoshi Eishiro
Organization Kanazawa University Hospital
Division name Department of Gastroenterology
Zip code
Address 13-1, Takaramahi, Kanazawa
TEL 076-265-2235
Email eishirom@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 13-1, Takaramahi, Kanazawa
TEL 076-265-2235
Homepage URL
Email shimakami@m-kanazawa.jp

Sponsor
Institute Kanazawa University Hospital
Institute
Department

Funding Source
Organization AbbVie Inc.
Organization
Division
Category of Funding Organization Other
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
2016 Year 02 Month 06 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
2016 Year 03 Month 05 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 02 Month 06 Day
Last modified on
2016 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024127

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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