UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015627
Receipt number R000018162
Scientific Title Effectiveness and safety of daclatasvir plus asunaprevir for chronic HCV genotype 1 infection
Date of disclosure of the study information 2014/11/07
Last modified on 2017/02/10 11:45:53

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effectiveness and safety of daclatasvir plus asunaprevir for chronic HCV genotype 1 infection

Acronym

Effectiveness and safety of daclatasvir plus asunaprevir

Scientific Title

Effectiveness and safety of daclatasvir plus asunaprevir for chronic HCV genotype 1 infection

Scientific Title:Acronym

Effectiveness and safety of daclatasvir plus asunaprevir

Region

Japan


Condition

Condition

Chronic HCV genotype 1b infection

Classification by specialty

Hepato-biliary-pancreatic medicine Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this prospective study is to evaluate the virological efficacy and safety of daclatasvir plus asunaprevir.

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 (SVR)

Key secondary outcomes

1. Efficacy and safety for patients with older or CKD (HD)
2. Predictive factor of SVR
3. Evaluation of adverse effects
4. Relationship between treatment outcome and HCV resistance-associated substitutions to daclatasvir


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

24-week course of daclatasvir (Daklinza; Bristol-Myers Squibb, Tokyo, Japan) (60 mg tablet once daily) and asunaprevir (Sunvepra; Bristol-Myers) (100 mg softgel capsule twice daily)

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Ineligible/Intolerance for interferon-based therapy
2. Non-virological response for the past interferon-based treatment
3. This study will be explained and informed consent needs to be obtained from all the patients.

Key exclusion criteria

1. Decompensated cirrhosis (Child B or C)
2. ALT level of more than five times the upper limit of normal range
3. Severe kidney damage (eGFR<30)
4. Coinfection with HBV or HIV
5. Women with pregnancy or breast feeding
6. Patients using contraindication drugs

Target sample size

400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Norihiro Furusyo

Organization

Kyushu University Hospital

Division name

Department of General Internal Medicine

Zip code


Address

3-1-1 Maidashi Higashi-ku, Fukuoka

TEL

+81926425909

Email

furusyo@gim.med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Eiichi Ogawa

Organization

Kyushu University Hospital

Division name

Department of General Internal Medicine

Zip code


Address

3-1-1 Maidashi Higashi-ku, Fukuoka

TEL

+81926425909

Homepage URL


Email

eogawa@gim.med.kyushu-u.ac.jp


Sponsor or person

Institute

Kyushu University 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


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

九州大学関連肝疾患治療研究会(KULDS)


Other administrative information

Date of disclosure of the study information

2014 Year 11 Month 07 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

* Daclatasvir plus asunaprevir for HCV genotype 1b was well tolerated and effective for patients without pre-existent NS5A RAVs or simeprevir failure, irrespective of fibrosis status.

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

2014 Year 11 Month 06 Day

Date of IRB


Anticipated trial start date

2014 Year 11 Month 06 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

2014 Year 11 Month 07 Day

Last modified on

2017 Year 02 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018162


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name