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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023086
Receipt No. R000026606
Scientific Title ITPA polymorphism effects on decrease of hemoglobin during sofosbuvir and ribavirin combination treatment for chronic hepatitis C
Date of disclosure of the study information 2016/07/08
Last modified on 2017/01/07

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Basic information
Public title ITPA polymorphism effects on decrease of hemoglobin during sofosbuvir and ribavirin combination treatment for chronic hepatitis C
Acronym ITPA SNP and sofosbuvir plus RBV
Scientific Title ITPA polymorphism effects on decrease of hemoglobin during sofosbuvir and ribavirin combination treatment for chronic hepatitis C
Scientific Title:Acronym ITPA SNP and sofosbuvir plus RBV
Region
Japan

Condition
Condition chronic hepatitis C
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To analyze ITPA polymorphism effects on decrease of hemoglobin during sofosbuvir and ribavirin combination treatment for chronic hepatitis C
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes sustained virological response (negative for serum HCV RNA at 24 weeks after the treatment)
Key secondary outcomes Hemoglobin during the treatment period

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
90 years-old >=
Gender Male and Female
Key inclusion criteria genotype 2 HCV-infected patients
Key exclusion criteria Patients with decompensated cirrhosis
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuaki Chayama
Organization Applied Life Science, Institute of Biomedical & Health Science, Hiroshima University
Division name Department of Gastroenterology a nd Metabolism
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL 082-257-5190
Email chayama@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Michio Imamura
Organization Applied Life Science, Institute of Biomedical & Health Science, Hir oshima University
Division name Department of Gastroenterology a nd Metabolism
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL 082-257-5190
Homepage URL
Email mimamura@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

Funding Source
Organization none
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 07 Month 08 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
Overall, SVR12 was achieved in 231 (94.7%) patients, based on intention to treat analysis. During the therapy, reduction of hemoglobin levels was significantly greater in ITPA genotype CC patients than CA/AA patients. Therefore, the cumulative proportion of patients with RBV dose reduction was significantly higher and total dose of RBV was significantly lower in patients with CC genotype compared to CA/AA genotypes. SVR12 rates were similar between ITPA genotype CC and CA/AA (94.7% and 94.4%, respectively, P=0.933). Multivariate logistic regression analysis identified FIB4 index <3.25 (OR, 9.388 for >3.25; P=0.005) and low body weight (OR, 1.059, for high body weight; P=0.017) as independent predictors for SVR12.
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 08 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
2016 Year 08 Month 31 Day
Date of closure to data entry
2016 Year 08 Month 31 Day
Date trial data considered complete
2016 Year 08 Month 31 Day
Date analysis concluded
2016 Year 09 Month 30 Day

Other
Other related information Patients with chronic genotype 2 HCV infection who were treated with sofosbuvir and ribavirin combination treatment between June 2015 and February 2016 at Hiroshima University were enrolled. Patients were divided into ITPA CC and CA/AA. Hemoglobin levels, ribavirin dose reduction and effects (sustained virological response rate) were analyzed.

Management information
Registered date
2016 Year 07 Month 08 Day
Last modified on
2017 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026606

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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