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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017149
Receipt No. 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

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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
Last 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
Email atsukawa-nms@umin.ac.jp

Public contact
1st 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
Email atsukawa-nms@umin.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 None

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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019893

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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