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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029262
Receipt No. R000033447
Scientific Title Examination of virological response and predictive factors in Elbasvir/Grazoprevir combination therapy for genotype1 infected chronic hepatitis C patients
Date of disclosure of the study information 2017/09/25
Last modified on 2019/10/12

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Basic information
Public title Examination of virological response and predictive factors in Elbasvir/Grazoprevir combination therapy for genotype1 infected chronic hepatitis C patients
Acronym Examination of virological response and predictive factors in Elbasvir/Grazoprevir combination therapy
Scientific Title Examination of virological response and predictive factors in Elbasvir/Grazoprevir combination therapy for genotype1 infected chronic hepatitis C patients
Scientific Title:Acronym Examination of virological response and predictive factors in Elbasvir/Grazoprevir combination therapy
Region
Japan

Condition
Condition Chronic hepatitis C
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the predictive factors associated with virological response and efficacy in Elbasvir/Grazoprevir combination therapy for genotype1 infected chronic hepatitis C patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sustained virological response 12 rate
Key secondary outcomes 1. Change in serum HCV RNA during treatment and follow-up duration
2. Change in hematological and biochemical test during treatment and follow-up duration
3. Change in Mac-2 Binding Protein,hyaluronic acid, type IV collagen,gamma globulin during treatment and follow-up duration.

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 Treat with Elbasvir/Grazoprevir combination therapy

ERELSA 50mg:one tablet once a day for 12 weeks
GRAZYNA 50mg:two tablets once a day 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
18 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria Patients who treated with Elbasvir/Grazoprevir combination therapy.
Patients with chronic hepatits C, genotype 1
Key exclusion criteria 1.History of allergy to Elbasvir/Grazoprevir
2.Decompensated liver cirrhosis
3.pregnant woman or lactating mother
4.Hepatocellular carcinoma, or other malignant tumor.
5.severe depression
6.Judged by investigator not to be appropriate for inclusion in this study
7.Receiving contraindicated drugs for
Elbasvir/Grazoprevir combined therapy
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Masanori
Middle name
Last name Atsukawa
Organization Nippon Medical School Chiba Hokusoh Hospital
Division name Division of Gastroenterology
Zip code 270-1196
Address 1715,Kamakari,Inzai,Chiba, 270-1694, Japan
TEL 0476991111
Email atsukawa-nms@umin.ac.jp

Public contact
Name of contact person
1st name Tomomi
Middle name
Last name Okubo
Organization Nippon Medical School Chiba Hokusoh Hospital
Division name Division of Gastroenterology
Zip code 270-1196
Address 1715,Kamakari,Inzai,Chiba, 270-1694, Japan
TEL 0476991111
Homepage URL
Email ma6-0154@nms.ac.jp

Sponsor
Institute Nippon Medical School Chiba Hokusoh Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Nippon Medical School Hospital
Nippon Medical School Musashi Kosugi Hospital
The Jikei University Hospital
Otakanomori Hospital
Hakujikai Healthcare foundation
Tokyo Metropolitan Bokutoh Hospital
Tokyo Medical University Ibaraki Medical Center
Shinmatsudo Central General Hospital
Japanese Red Cross Narita Hospital
Nagoya City University Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nipon medical Chiba hokuso Hospital
Address 1715 Kamagari Inzai Chiba
Tel 0476991111
Email araraki@nms.ac.jp

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
2017 Year 09 Month 25 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
2017 Year 06 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 07 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
2017 Year 09 Month 24 Day
Last modified on
2019 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033447

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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