UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029262 |
|---|---|
| Receipt number | 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 | 2021/06/23 06:17:13 |
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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 | 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
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
ma6-0154@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Chiba Hokusoh Hospital
Institute
Department
Personal name
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
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
Main results already published
Date of protocol fixation
| 2017 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 30 | Day |
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
| 2021 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033447
