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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016558
Receipt No. R000017954
Scientific Title Analysis of efficacy and safety of antiviral therapy with daclatasvir and asunaprevir for hepatitis C after organ transplantation -Pilot Study-
Date of disclosure of the study information 2015/02/16
Last modified on 2018/06/12

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Basic information
Public title Analysis of efficacy and safety of antiviral therapy with daclatasvir and asunaprevir for hepatitis C after organ transplantation -Pilot Study-
Acronym Interferon-free therapy for posttransplant hepatitis C
Scientific Title Analysis of efficacy and safety of antiviral therapy with daclatasvir and asunaprevir for hepatitis C after organ transplantation -Pilot Study-
Scientific Title:Acronym Interferon-free therapy for posttransplant hepatitis C
Region
Japan

Condition
Condition hepatitis C after transplantation
Classification by specialty
Hepato-biliary-pancreatic medicine Surgery in general Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To clarify the pharmacokinetics, efficacy and safety of antiviral therapy with dacltasvir and asunaprevir for hepatitis C after organ transplantation
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pharmacokinetics of antiviral therapy with dacltasvir and asunaprevir for hepatitis C after organ transplantation
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Hepatitis C after organ transplantation
2. HCV genotype 1
3. 20 years old and over
4. Written informed consent for participation in this study is obtained
Key exclusion criteria without abilty to understand informed consent
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Ohdan
Organization Hiroshima University Hospital
Division name Trasnplantation surgery
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima
TEL 082-257-5220
Email hohdan@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Ide
Organization Hiroshima University Hospital
Division name Trasnplantation surgery
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima
TEL 082-257-5222
Homepage URL
Email ideken@hiroshima-u.ac.jp

Sponsor
Institute Trasnplantation surgery, Hiroshima University Hospital
Institute
Department

Funding Source
Organization Trasnplantation surgery, Hiroshima University Hospital
Organization
Division
Category of Funding Organization Other
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
2015 Year 02 Month 16 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 Completed
Date of protocol fixation
2014 Year 10 Month 16 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will observe the pharmacokinetics, efficacy and safety of anti-viral therapy with daclatasvir and asunaprevir for hepatitis C after organ transplantatio, and analyze teh predictive factors of the efficacy and safety.

Management information
Registered date
2015 Year 02 Month 16 Day
Last modified on
2018 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017954

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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