UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of efficacy and safety of antiviral therapy with daclatasvir and asunaprevir for hepatitis C after organ transplantation -Pilot Study-
Title of the study (Brief title)	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	Hideki Ohdan
Organization	Hiroshima University Hospital
Division name	Trasnplantation surgery
Address	1-2-3, Kasumi, Minami-ku, Hiroshima
TEL	082-257-5220
Email	hohdan@hiroshima-u.ac.jp

Public contact
Name of contact person	Kentaro Ide
Organization	Hiroshima University Hospital
Division name	Trasnplantation surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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