UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007919
Receipt No. R000009316
Scientific Title Administration of erythropoietin on telaprevir/PEG-IFN/RBV triple combination therapy in HCV patients with low pre-treatment hemoglobin levels.
Date of disclosure of the study information 2012/05/10
Last modified on 2015/05/12

* 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 Administration of erythropoietin on telaprevir/PEG-IFN/RBV triple combination therapy in HCV patients with low pre-treatment hemoglobin levels.
Acronym Administration of erythropoietin on telaprevir/PEG-IFN/RBV triple combination therapy in HCV patients with low pre-treatment hemoglobin levels.
Scientific Title Administration of erythropoietin on telaprevir/PEG-IFN/RBV triple combination therapy in HCV patients with low pre-treatment hemoglobin levels.
Scientific Title:Acronym Administration of erythropoietin on telaprevir/PEG-IFN/RBV triple combination therapy in HCV patients with low pre-treatment hemoglobin levels.
Region
Japan

Condition
Condition Chronic hepatitis C
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To clarify whether administration of erythropoietin and ITPA genotype affect the treatment response and adverse events in telaprevir/PEG-IFN/RBV triple combination therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adherence of telaprevir/PEG-IFN/RBV triple combination therapy up to 12 weeks
Key secondary outcomes 1) Change of hemoglobin level
2) Differences of treatment efficacy depending on IL28B or ITPA genotypes
3) Correlation between drug adherence of telaprevir/PEG-IFN/RBV and treatment efficacy
4) Ratio of discontinuation and treatment duration of telaprevir/PEG-IFN/RBV
5) Correlation between viral mutation and treatment efficacy
6) Correlation between drug adherence and telaprevir-resistant viral mutation
7) Correlation between telaprevir-resistant viral mutation and plasma concentration of telaprevir
8) Difference of treatment efficacy depending on administration of erythropoietin

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Gene
Interventions/Control_1 Administration of erythropoietin
Interventions/Control_2 ITPA genotype
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
70 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients over 20 years of age
2) Pre-treatment hemoglobin level is below 13 g/dl
3) HCV patients with serogroup 1 and high viral load
4) Patients with IL28B and ITPA genotypes determined
Key exclusion criteria 1) Patients over 70 years of age
2) Patients with liver cirrhosis
3) Patients with hepatocellular carcinoma or other malignancies
4) Patients co-infected with HIV or HBV
5) Patients judged by doctor that participation in the study is improper
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kei Fujiwara
Organization Nagoya City University, Graduate School of Medical Sciences
Division name Department of Gastroenterology and Metabolism
Zip code
Address 1 Kawasumi, Mizuho, Mizuho, Nagoya
TEL 052-853-8211
Email keifuji@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Matsuura
Organization Nagoya City University, Graduate School of Medical Sciences
Division name Department of Gastroenterology and Metabolism
Zip code
Address 1 Kawasumi, Mizuho, Mizuho, Nagoya
TEL 052-853-8211
Homepage URL
Email keifuji@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University, Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization Department of Virology,
Nagoya City University, Graduate School of Medical Sciences
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
2012 Year 05 Month 10 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
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
2012 Year 02 Month 06 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2014 Year 12 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 05 Month 09 Day
Last modified on
2015 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009316

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.