UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044234
Receipt number R000050518
Scientific Title Effect and adverse effect of direct acting antivirals
Date of disclosure of the study information 2021/05/18
Last modified on 2021/05/17 21:04:49

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Basic information

Public title

Effect and adverse effect of direct acting antivirals for the patients with HCV

Acronym

Effect and adverse effect of direct acting antivirals for the patients with HCV

Scientific Title

Effect and adverse effect of direct acting antivirals

Scientific Title:Acronym

Effect and adverse effect of direct acting antivirals

Region

Japan


Condition

Condition

Chronic hepatitis, type C, Liver cirrhosis, type C

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to examine the efficacy and the frequencies of adverse effect in the patients with HCV receiving direct acting antivirals therapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

sustained virological response

Key secondary outcomes



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

Administration of DAAs

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. more than 20 years old
2. patient with genotype 1b HCV
3. over 50,000/ micro litter of platelet
4. the patient received curative HCC treatment (if experienced HCC)
5. the patient received explanation and consent
6. HCV RNA positive (if treatment naive patient)

Key exclusion criteria

1. the female patient in pregnancy or breast-feeding
2. the patient experienced allergic reaction for daclatasvir and or asunaprevir
3. the liver cirrhosis patient with over Child-pugh score 7
4. the patient whose blood examination data was below the standard value
5. the patient the investigator judged unsuitable for study

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Kazuhiko
Middle name
Last name Nakao

Organization

Nagasaki university hospital

Division name

Department of gastroenterology and hepatology

Zip code

852-8501

Address

Sakamoto 1-7-1, Nagasaki city

TEL

0958197481

Email

kazuhiko@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name Naota
Middle name
Last name Taura

Organization

Nagasaki university hospital

Division name

Department of gastroenterology and hepatology

Zip code

8528117

Address

Sakamoto 1-7-1, Nagasaki city

TEL

0958197481

Homepage URL


Email

ntaura-g@nagasaki-u.ac.jp


Sponsor or person

Institute

Department of gastroenterology and hepatology, Nagasaki university hospital

Institute

Department

Personal name



Funding Source

Organization

Department of gastroenterology and hepatology, Nagasaki university hospital

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

Clinincal research center, Nagasaki university hospital

Address

1-7-1 Sakamoto

Tel

0958197726

Email

samamoto@nagasaki-u.ac.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

2021 Year 05 Month 18 Day


Related information

URL releasing protocol

The study was aborted.

Publication of results

Unpublished


Result

URL related to results and publications

The study was aborted.

Number of participants that the trial has enrolled

0

Results

Although a research design was planed, the study was aborted.

Results date posted

2021 Year 05 Month 17 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

No participant

Participant flow

No participant

Adverse events

None (No participant)

Outcome measures

The study was aborted.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2014 Year 09 Month 02 Day

Date of IRB

2014 Year 09 Month 02 Day

Anticipated trial start date

2017 Year 12 Month 31 Day

Last follow-up date

2017 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 05 Month 17 Day

Last modified on

2021 Year 05 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050518


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name