UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017149
Receipt number R000019893
Scientific Title Predictive factors associated with virological response in Daclatasvir and Asunaprevir combination therapy for genotype1b-infected chronic hepatitis C patients : multicenter study
Date of disclosure of the study information 2015/04/17
Last modified on 2017/04/17 10:04:11

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Basic information

Public title

Predictive factors associated with virological response in Daclatasvir and Asunaprevir combination therapy for genotype1b-infected chronic hepatitis C patients : multicenter study

Acronym

Predictive factors for virological response in Daclatasvir and Asunaprevir combination therapy

Scientific Title

Predictive factors associated with virological response in Daclatasvir and Asunaprevir combination therapy for genotype1b-infected chronic hepatitis C patients : multicenter study

Scientific Title:Acronym

Predictive factors for virological response in Daclatasvir and Asunaprevir combination therapy

Region

Japan


Condition

Condition

Chronic hepatitis C

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To confirm the Predictive factors associated with virological response in Daclatasvir and Asunaprevir combination therapy for genotype1b-infected chronic hepatitis C patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Sustained virological response rate

Key secondary outcomes

1. Change in serum HCV RNA during treatment and follow-up duration
2. Change in hematological and biochemical test during treatment and follow-up duration
3. Change in beta-hydroxycholesterol during treatment and follow-up duration
4. Safety and efficacy of treatment for patients with renal insufficiency or renal failure including hemodyalysis
5. Change in Mac-2 Binding Protein,hyaluronic acid, type IV collagen,gamma globulin during treatment and follow-up duration.


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

Patients were treated with Daclatasvir and Asunaprevir combination therapy

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

18 years-old <=

Age-upper limit

85 years-old >

Gender

Male and Female

Key inclusion criteria

Patients with chronic hepatitis C who treat with Daclatasvir/Asunaprevir combination therapy.

Key exclusion criteria

1.History of allergy to Daclatasvir, and Asunaprevir.
2.Decompensated liver cirrhosis
3.pregnant woman or lactating mother
4.Hepatocellular carcinoma, or other malignant tumor.
5.severe depression
6.Judged by investigator not to be appropriate for inclusion in this study

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masanori Atsukawa

Organization

Nippon Medical School Chiba Hokusoh Hospital

Division name

Division of Gastroenterology

Zip code


Address

1715,Kamakari,Inzai,Chiba, 270-1694, Japan

TEL

0476-99-1111

Email

atsukawa-nms@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masanori Atsukawa

Organization

Nippon Medical School Chiba Hokusoh Hospital

Division name

Division of Gastroenterology

Zip code


Address

1715,Kamakari,Inzai,Chiba, 270-1694, Japan

TEL

0476-99-1111

Homepage URL


Email

atsukawa-nms@umin.ac.jp


Sponsor or person

Institute

Nippon Medical School Chiba Hokusoh Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

None


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

日本医科大学付属病院(東京都)、東京慈恵会医科大学付属柏病院(千葉県)、東京慈恵会医科大学葛飾医療センター(東京都)、千葉徳洲会病院(千葉県)、博慈会記念病院(東京都)、東京都立墨東病院(東京都)、町田市民病院(東京都)、茨城県立中央病院・茨城地域がんセンター(茨城県)、東京医科大学茨城医療センター(茨城県)、我孫子聖仁会病院(千葉県)


Other administrative information

Date of disclosure of the study information

2015 Year 04 Month 17 Day


Related information

URL releasing protocol


Publication of results

Published


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

2015 Year 04 Month 17 Day

Date of IRB


Anticipated trial start date

2015 Year 04 Month 17 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 04 Month 16 Day

Last modified on

2017 Year 04 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019893


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name