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
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
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
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
