UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026640 |
|---|---|
| Receipt number | R000030595 |
| Scientific Title | Predictive factors associated with virological response in Ombitasvir/Paritaprevir/Ritonavir/Ribavirin combination therapy for genotype2a infected chronic hepatitis C patients |
| Date of disclosure of the study information | 2017/03/23 |
| Last modified on | 2019/03/25 10:19:39 |
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Basic information
Public title
Predictive factors associated with virological response in Ombitasvir/Paritaprevir/Ritonavir/Ribavirin combination therapy for genotype2a infected chronic hepatitis C patients
Acronym
Virological response in Ombitasvir/Paritaprevir/Ritonavir/Ribavirin combination therapy for genotype2a infected chronic hepatitis C patients
Scientific Title
Predictive factors associated with virological response in Ombitasvir/Paritaprevir/Ritonavir/Ribavirin combination therapy for genotype2a infected chronic hepatitis C patients
Scientific Title:Acronym
Virological response in Ombitasvir/Paritaprevir/Ritonavir/Ribavirin combination therapy for genotype2a infected chronic hepatitis C patients
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Inspection of the curative effect and to confirm the predictive factors associated with virological response and in Ombitasvir/Paritaprevir/Ritonavir/Ribavirin combination therapy for genotype2a 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 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 Ombitasvir/Paritaprevir /Ritonavir/Ribavirin combination therapy.
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
Case of introducing ombitasvir/paritaprevir/ritonavir/ribavirin combination therapy for Genotype 2 type C chronic liver disease
Key exclusion criteria
1History of allergy to Ombitasvir/Paritaprevir /Ritonavir/Ribavirin
2Liver cirrhosis
3Patients with creatinine clearance less than 50 ml / min
4Pregnant woman or lactating mother
5Hepatocellular carcinoma, or other malignant tumor
6Judged by investigator not to be appropriate for inclusion in this study
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
270-1694
Address
1715 Kamagari Inzai Chiba
TEL
0476-99-1111
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
2701694
Address
1715 Kamagari Inzai Chiba
TEL
0476-99-1111
Homepage URL
atsukawa-nms@umin.ac.jp
Sponsor or person
Institute
Nipppon 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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School Chiba Hokusoh Hospital institutional review board
Address
1715, Kamakari, Inzai, Chiba, Japan
Tel
0476-99-1111
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 | 03 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
98
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
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 28 | 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 | 03 | Month | 22 | Day |
Last modified on
| 2019 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030595
