UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019391
Receipt number R000022430
Scientific Title Study of drug resistance virus in oral agents to genotype 1 chronic hepatitis
Date of disclosure of the study information 2015/10/20
Last modified on 2015/10/18 13:23:44

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Basic information

Public title

Study of drug resistance virus in oral agents to genotype 1 chronic hepatitis

Acronym

Study of drug resistance virus to genotype 1 chronic hepatitis

Scientific Title

Study of drug resistance virus in oral agents to genotype 1 chronic hepatitis

Scientific Title:Acronym

Study of drug resistance virus to genotype 1 chronic hepatitis

Region

Japan


Condition

Condition

Genotype 1 chronic hepatitis C

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Recently, direct-acting antiviral agents (DAAs) which specifically effect for HCV virus is developed. Drug resistance virus influence the efficacy of DAAs. The first generation treatment of Daclatasvir/Asunaprevir were available from 2014 in Japan. Drug resistance virus was deeply associated with the efficacy of treatment in Daclatasvir/Asunaprevir treatment. Drug resistance virus is expected to influence the outcome of second generation treatments (ledipasvir/sofosbuvir or ombitasvir/paritaprevir/ritonavir etc.). But it has not been reported on the real world clinical setting in Japan. It is important to clarify the association between second generation DAAs treatments and drug resistance virus.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The dynamic state of drug resistance virus was studied before pre-treatment and viral breakthrough.

Key secondary outcomes

HCV RNA levels were assessed at pre treatment and 2, 4, 8, 12weeks or end of treatment (EOT) and at 12 and 24 weeks after completion of treatment, and routine biochemical and hematological tests were also performed.


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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

Eligible patients were 20 to 85years of chronic HCV genotype 1 infection. Patients received the second generation oral agents(ledipasvir/sofosbuvir or ombitasvir/paritaprevir/ritonavir etc.) for 12 weeks.

Key exclusion criteria

Patients with decompensated liver disease, coinfection with hepatitis B virus or human immunodeficiency virus, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis or Wilson's disease were excluded. Patients with uncontrollable hypertension or diabetes mellitus and those with a history of alcohol abuse were also excluded.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshio Sumida

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Molecular Gastroenterology and Hepatology

Zip code


Address

465, Kajii-chou, Kawaramachi, Kamigyou-ku,Kyoto 602-0841, Japan

TEL

075-251-5519

Email

sumida@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideki Fujii

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Molecular Gastroenterology and Hepatology

Zip code


Address

465, Kajii-chou, Kawaramachi, Kamigyou-ku,Kyoto 602-0841, Japan

TEL

075-251-5519

Homepage URL

http://www.f.kpu-m.ac.jp/k/syokanai/

Email

fuhideki@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine, Department of Molecular Gastroenterology and Hepatology

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


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 10 Month 20 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

Enrolling by invitation

Date of protocol fixation

2015 Year 09 Month 25 Day

Date of IRB


Anticipated trial start date

2015 Year 09 Month 25 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective study.Target sample size are 200 cases. We treat the genotype 1 chronic hepatitis with the second generation DAAs as followed by the manufacturer's recommendations. This study have no blind trial or randomization. Patients who are on an outpatients of Kyoto Prefectural University of Medicine or affiliated hospitals in Kinki area and agree with the clinical research are candidate. The dynamic state of drug resistance virus was studied before pre-treatment and viral breakthrough. HCV RNA levels were assessed at pre treatment and 2, 4, 8, 12weeks or end of treatment (EOT) and at 12 and 24 weeks after completion of treatment. Clinical history, clinical background, routine biochemical, hematological tests, were also accumulated and performed.


Management information

Registered date

2015 Year 10 Month 18 Day

Last modified on

2015 Year 10 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022430


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name