UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017988
Receipt number R000020839
Scientific Title Efficacy and safety of peg-IFN+RBV combined therapy in failure of direct antiviral agents therapy for chronic hepatitis C and liver cirrhosis C
Date of disclosure of the study information 2015/06/20
Last modified on 2019/06/23 09:14:12

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Basic information

Public title

Efficacy and safety of peg-IFN+RBV combined therapy in failure of direct antiviral agents therapy for chronic hepatitis C and liver cirrhosis C

Acronym

Efficacy and safety of peg-IFN+RBV combined therapy in failure of direct antiviral agents therapy for chronic hepatitis C and liver cirrhosis C

Scientific Title

Efficacy and safety of peg-IFN+RBV combined therapy in failure of direct antiviral agents therapy for chronic hepatitis C and liver cirrhosis C

Scientific Title:Acronym

Efficacy and safety of peg-IFN+RBV combined therapy in failure of direct antiviral agents therapy for chronic hepatitis C and liver cirrhosis C

Region

Japan


Condition

Condition

Chronic hepatitis and compensated liver cirrhosis, type C

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of efficacy and safety for pegIFN plus RBV combined therapy against chronic hepatitis and compensated liver cirrhosis type C

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

PegIFN plus RBV

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

good informed patients

Key exclusion criteria

un-tolerable for combined therapy
de compensated liver cirrhosis

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Shinji Shimoda
Middle name
Last name Shinji Shimoda

Organization

Faculty of Medicine, Kyushu University

Division name

Dept. of Medicine and Biosystemic Science

Zip code

8128582

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka

TEL

092-642-5231

Email

sshimoda@intmed1.med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name Shinji Shimoda
Middle name
Last name Shinji Shimoda

Organization

Faculty of Medicine, Kyushu University

Division name

Dept. of Medicine and Biosystemic Science

Zip code

8128582

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka

TEL

092-642-5231

Homepage URL


Email

sshimoda@intmed1.med.kyushu-u.ac.jp


Sponsor or person

Institute

Faculty of Medicine, Kyushu University
Dept. of Medicine and Biosyste

Institute

Department

Personal name



Funding Source

Organization

Faculty of Medicine, Kyushu University
Dept. of Medicine and Biosyste

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

Kyushu University Hospital

Address

Fukuoka City, Higashi-Ku

Tel

092-642-5228

Email

sshimoda@intmed1.med.kyushu-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

2015 Year 06 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

0

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

Terminated

Date of protocol fixation

2015 Year 06 Month 18 Day

Date of IRB

2015 Year 06 Month 01 Day

Anticipated trial start date

2015 Year 06 Month 18 Day

Last follow-up date

2019 Year 05 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

2015 Year 06 Month 20 Day

Last modified on

2019 Year 06 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020839


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name