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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015627
Receipt No. R000018162
Scientific Title Effectiveness and safety of daclatasvir plus asunaprevir for chronic HCV genotype 1 infection
Date of disclosure of the study information 2014/11/07
Last modified on 2017/02/10

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Basic information
Public title Effectiveness and safety of daclatasvir plus asunaprevir for chronic HCV genotype 1 infection
Acronym Effectiveness and safety of daclatasvir plus asunaprevir
Scientific Title Effectiveness and safety of daclatasvir plus asunaprevir for chronic HCV genotype 1 infection
Scientific Title:Acronym Effectiveness and safety of daclatasvir plus asunaprevir
Region
Japan

Condition
Condition Chronic HCV genotype 1b infection
Classification by specialty
Hepato-biliary-pancreatic medicine Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this prospective study is to evaluate the virological efficacy and safety of daclatasvir plus asunaprevir.
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 (SVR)
Key secondary outcomes 1. Efficacy and safety for patients with older or CKD (HD)
2. Predictive factor of SVR
3. Evaluation of adverse effects
4. Relationship between treatment outcome and HCV resistance-associated substitutions to daclatasvir

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 24-week course of daclatasvir (Daklinza; Bristol-Myers Squibb, Tokyo, Japan) (60 mg tablet once daily) and asunaprevir (Sunvepra; Bristol-Myers) (100 mg softgel capsule twice daily)
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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1. Ineligible/Intolerance for interferon-based therapy
2. Non-virological response for the past interferon-based treatment
3. This study will be explained and informed consent needs to be obtained from all the patients.
Key exclusion criteria 1. Decompensated cirrhosis (Child B or C)
2. ALT level of more than five times the upper limit of normal range
3. Severe kidney damage (eGFR<30)
4. Coinfection with HBV or HIV
5. Women with pregnancy or breast feeding
6. Patients using contraindication drugs
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiro Furusyo
Organization Kyushu University Hospital
Division name Department of General Internal Medicine
Zip code
Address 3-1-1 Maidashi Higashi-ku, Fukuoka
TEL +81926425909
Email furusyo@gim.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiichi Ogawa
Organization Kyushu University Hospital
Division name Department of General Internal Medicine
Zip code
Address 3-1-1 Maidashi Higashi-ku, Fukuoka
TEL +81926425909
Homepage URL
Email eogawa@gim.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Hospital
Institute
Department

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

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 九州大学関連肝疾患治療研究会(KULDS)

Other administrative information
Date of disclosure of the study information
2014 Year 11 Month 07 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
* Daclatasvir plus asunaprevir for HCV genotype 1b was well tolerated and effective for patients without pre-existent NS5A RAVs or simeprevir failure, irrespective of fibrosis status.
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
2014 Year 11 Month 06 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 06 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
2014 Year 11 Month 07 Day
Last modified on
2017 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018162

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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