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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000022567
Receipt No. R000026009
Scientific Title To calculate the efficacy and safety of ABT-493/ABT-530 for HCV in Japan, Randmised non-blinded multicenter trial
Date of disclosure of the study information 2016/06/01
Last modified on 2016/06/23

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Basic information
Public title To calculate the efficacy and safety of ABT-493/ABT-530 for HCV in Japan, Randmised non-blinded multicenter trial
Acronym The efficacy and safety of ABT-493/ABT-530 for HCV genotype 1. (CERTAIN-1)
Scientific Title To calculate the efficacy and safety of ABT-493/ABT-530 for HCV in Japan, Randmised non-blinded multicenter trial
Scientific Title:Acronym The efficacy and safety of ABT-493/ABT-530 for HCV genotype 1. (CERTAIN-1)
Region
Japan

Condition
Condition HCV
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The efficacy and safety of ABT-493/ABT-530 for HCV
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes SVR of 12 weeks with after treatment
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 ABT-493/ABT-530 treatment for 12 weeks.
CH or LC.
Interventions/Control_2 LDV/SOF treatment for 12 weeks.
CH or LC.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria CH or LC
Key exclusion criteria HCC
Target sample size 4

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiharu Komatsu
Organization Shinshu University of Medicine
Division name Gastroenterology
Zip code
Address Asahi 3-1-1, Matsumoto, Nagano
TEL 0263-37-2634
Email komichi@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Michiharu Komatsu
Organization Shinshu University of Medicine
Division name Gastroenterology
Zip code
Address Asahi 3-1-1, Matsumoto, Nagano
TEL 0263-37-2634
Homepage URL
Email komichi@shinshu-u.ac.jp

Sponsor
Institute Shinshu University of Medicine
Institute
Department

Funding Source
Organization AbbVie
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2016 Year 06 Month 01 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 Terminated
Date of protocol fixation
2016 Year 05 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 06 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 We terminated this trial by consulted to this clinical trial's client.
This clinical trial information is exposed in Clinical Trial.Gov(NCT02707952).

Management information
Registered date
2016 Year 06 Month 01 Day
Last modified on
2016 Year 06 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026009

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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