UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017149 |
|---|---|
| Receipt number | R000019893 |
| Scientific Title | Predictive factors associated with virological response in Daclatasvir and Asunaprevir combination therapy for genotype1b-infected chronic hepatitis C patients : multicenter study |
| Date of disclosure of the study information | 2015/04/17 |
| Last modified on | 2017/04/17 10:04:11 |
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Basic information
Public title
Predictive factors associated with virological response in Daclatasvir and Asunaprevir combination therapy for genotype1b-infected chronic hepatitis C patients : multicenter study
Acronym
Predictive factors for virological response in Daclatasvir and Asunaprevir combination therapy
Scientific Title
Predictive factors associated with virological response in Daclatasvir and Asunaprevir combination therapy for genotype1b-infected chronic hepatitis C patients : multicenter study
Scientific Title:Acronym
Predictive factors for virological response in Daclatasvir and Asunaprevir combination therapy
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To confirm the Predictive factors associated with virological response in Daclatasvir and Asunaprevir combination therapy for genotype1b-infected chronic hepatitis C patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
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 beta-hydroxycholesterol during treatment and follow-up duration
4. Safety and efficacy of treatment for patients with renal insufficiency or renal failure including hemodyalysis
5. 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
Patients were treated with Daclatasvir and Asunaprevir 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
Patients with chronic hepatitis C who treat with Daclatasvir/Asunaprevir combination therapy.
Key exclusion criteria
1.History of allergy to Daclatasvir, and Asunaprevir.
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
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanori Atsukawa |
Organization
Nippon Medical School Chiba Hokusoh Hospital
Division name
Division of Gastroenterology
Zip code
Address
1715,Kamakari,Inzai,Chiba, 270-1694, Japan
TEL
0476-99-1111
atsukawa-nms@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanori Atsukawa |
Organization
Nippon Medical School Chiba Hokusoh Hospital
Division name
Division of Gastroenterology
Zip code
Address
1715,Kamakari,Inzai,Chiba, 270-1694, Japan
TEL
0476-99-1111
Homepage URL
atsukawa-nms@umin.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
None
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
日本医科大学付属病院(東京都)、東京慈恵会医科大学付属柏病院（千葉県）、東京慈恵会医科大学葛飾医療センター（東京都）、千葉徳洲会病院（千葉県）、博慈会記念病院（東京都）、東京都立墨東病院（東京都）、町田市民病院（東京都）、茨城県立中央病院・茨城地域がんセンター（茨城県）、東京医科大学茨城医療センター（茨城県）、我孫子聖仁会病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 17 | 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
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
| 2015 | Year | 04 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 17 | 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
| 2015 | Year | 04 | Month | 16 | Day |
Last modified on
| 2017 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019893
