UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prediction of efficacy to simeprevir-based triple therapy in patients with genotype 1b and high viral load
Title of the study (Brief title)	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	Hideyuki Tamai
Organization	Wakayama Medical University
Division name	Second department of internal medicine
Address	811-1, Kimidera, Wakayama City
TEL	073-447-2300
Email	tamahide@wakayama-med.ac.jp

Public contact
Name of contact person	Hideyuki Tamai
Organization	Wakayama Medical University
Division name	Second department of internal medicine
Address	811-1, Kimidera, Wakayama City
TEL	073-447-2300
Homepage URL
Email	tamahide@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025918