UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017023
Receipt number R000019741
Scientific Title Antiviral therapy for HCV using direct acting antiviral drugs in patients with chronic hepatitis C undergoing hemodialysis.
Date of disclosure of the study information 2015/04/15
Last modified on 2020/10/05 16:19:16

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Basic information

Public title

Antiviral therapy for HCV using direct acting antiviral drugs in patients with chronic hepatitis C undergoing hemodialysis.

Acronym

Antiviral therapy for HCV using direct acting antiviral drugs in patients with chronic hepatitis C undergoing hemodialysis.

Scientific Title

Antiviral therapy for HCV using direct acting antiviral drugs in patients with chronic hepatitis C undergoing hemodialysis.

Scientific Title:Acronym

Antiviral therapy for HCV using direct acting antiviral drugs in patients with chronic hepatitis C undergoing hemodialysis.

Region

Japan


Condition

Condition

Patients with HCV genotype 1B infection who are undergoing maintenance hemodialysis.

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of the safety and efficacy of oral antiviral therapy for HCV using asunaprevir and daclatasvir in patients with chronic HCV infection undergoing hemodialysis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Antiviral efficacy to eradicate HCV in patients with chronic HCV infection undergoing hemodialysis.

Key secondary outcomes

Safety of oral antiviral therapy in patients with chronic HCV infection undergoing hemodialysis.


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

asunaprevir 200mg twice daily and
daclatasvir 60mg once daily for 24 weeks.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with HCV genotype 1B infection who are undergoing maintenance hemodialysis.

Key exclusion criteria

Patients infected with HCV other than HCV genotype 1B.
Patients with Child-Pugh class B or C cirrhosis.

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Hidenori
Middle name
Last name Toyoda

Organization

Ogaki Municipal Hospital

Division name

Gastroenterology

Zip code

503-8502

Address

4-86, Minaminokawa, Ogaki, Gifu

TEL

0584-81-3341(1561)

Email

tkumada@he.mirai.ne.jp


Public contact

Name of contact person

1st name Hidenori
Middle name
Last name Toyoda

Organization

Ogaki Municipal Hospital

Division name

Gastroenterology

Zip code

503-8502

Address

4-86, Minaminokawa, Ogaki, Gifu

TEL

0584-81-3341(1561)

Homepage URL


Email

tkumada@he.mirai.ne.jp


Sponsor or person

Institute

Ogaki Municipal Hospital

Institute

Department

Personal name



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

Ogaki Municipal Hospital

Address

4-86 Minaminokawa, Ogaki Gifu

Tel

0584-81-3341

Email

tkumada@he.mirai.ne.jp


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 04 Month 15 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

Open public recruiting

Date of protocol fixation

2014 Year 07 Month 09 Day

Date of IRB

2014 Year 07 Month 25 Day

Anticipated trial start date

2014 Year 10 Month 01 Day

Last follow-up date

2015 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2016 Year 01 Month 15 Day


Other

Other related information



Management information

Registered date

2015 Year 04 Month 02 Day

Last modified on

2020 Year 10 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019741


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name