UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022491
Receipt number R000025918
Scientific Title Prediction of efficacy to simeprevir-based triple therapy in patients with genotype 1b and high viral load
Date of disclosure of the study information 2016/05/27
Last modified on 2017/05/29 08:48:17

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Basic information

Public title

Prediction of efficacy to simeprevir-based triple therapy in patients with genotype 1b and high viral load

Acronym

Prediction of efficacy to simeprevir-based triple therapy in patients with genotype 1b and high viral load

Scientific Title

Prediction of efficacy to simeprevir-based triple therapy in patients with genotype 1b and high viral load

Scientific Title:Acronym

Prediction of efficacy to simeprevir-based triple therapy in patients with genotype 1b and high viral load

Region

Japan


Condition

Condition

Patients with genotype 1b hepatitis C virus and high virus load

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify predictive factors of sustained virological response to simeprevir with pegylated interferon and ribavirin

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sustained virological response at 24 weeks after the end of therapy

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

Prevention

Type of intervention

Other

Interventions/Control_1

To evaluate virus variant and virus dynamics within 2 weeks, 5ml/time of blood sample are collected 3 times.

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

100 years-old >

Gender

Male and Female

Key inclusion criteria

Adult patients with genotype 1 high viral load

Key exclusion criteria

1) pregnant women, women who may have been pregnant, lactating women, men whose partners were pregnant, or men whose partners hoped to become pregnant; 2) patients who used shosaikoto (a Kampo medicine); 3) intractable heart disease; 4) renal failure or renal dysfunction with creatinine clearance <50 mL/min; 5) patients with uncontrollable psychoneurotic disorders; 6) hemoglobin (Hb) level <11 g/dL; 7) platelet count <70,000/mm3; 8) white blood cell count <1500/mm3 (or granulocyte count <1000/mm3); and 9) hepatic failure or all types of cancer.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideyuki Tamai

Organization

Wakayama Medical University

Division name

Second department of internal medicine

Zip code


Address

811-1, Kimidera, Wakayama City

TEL

073-447-2300

Email

tamahide@wakayama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideyuki Tamai

Organization

Wakayama Medical University

Division name

Second department of internal medicine

Zip code


Address

811-1, Kimidera, Wakayama City

TEL

073-447-2300

Homepage URL


Email

tamahide@wakayama-med.ac.jp


Sponsor or person

Institute

Wakayama Medical University

Institute

Department

Personal name



Funding Source

Organization

Wakayama Medical University

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

2016 Year 05 Month 27 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

2014 Year 01 Month 15 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 15 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

2016 Year 05 Month 27 Day

Last modified on

2017 Year 05 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025918


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name