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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004309
Receipt No. R000005167
Scientific Title The influence of nucleoside transporter on pharmacokinetics, effect and adverse events of ribavirin
Date of disclosure of the study information 2010/10/02
Last modified on 2016/04/01

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Basic information
Public title The influence of nucleoside transporter on pharmacokinetics, effect and adverse events of ribavirin
Acronym The influence of nucleoside transporter on pharmacokinetics, effect and adverse events of ribavirin
Scientific Title The influence of nucleoside transporter on pharmacokinetics, effect and adverse events of ribavirin
Scientific Title:Acronym The influence of nucleoside transporter on pharmacokinetics, effect and adverse events of ribavirin
Region
Japan

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

Objectives
Narrative objectives1 The Investigation of drug interaction between ribavirin and nucleoside transporter inhibitor
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pharmacokinetics of ribavirin
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-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
Interventions/Control_1 Administration of ribavirin without nucleoside transporter inhibitor
Interventions/Control_2 Administration of ribavirin with nucleoside transporter inhibitor
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
50 years-old >=
Gender Male
Key inclusion criteria 1) Healthy male subjects
2) Older than 20 years, younger than 50 years
3) Weight less than 90 kg, and body mass index(BMI) of 18.5-25.0
4) Written informed consent
Key exclusion criteria 1) Anemia
2) Virus infection last 4 weeks prior to the study
3) Medication last 2 weeks prior to the study
4) Participation in a clinical trial last 3 months prior to the study
5) Intake of alcohol last 48 hours prior to the study
6) Blood donation more than 400 mL last 6 months prior to the study
7) Possible the autoimmune disease
8) Allergic reaction
9) Alcohol or drug abuse
10) Positive for HBs antigen, HCV antibody, and syphilis
11) Other inappropriate cases
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato Homma
Organization Tsukuba University Hospital
Division name Pharmacy Department
Zip code
Address 2-1-1 Amakubo, Tsukuba, Ibaraki
TEL 029-853-3843
Email masatoh@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiharu Suzuki
Organization Tsukuba University Hospital
Division name Pharmacy Department
Zip code
Address 2-1-1 Amakubo, Tsukuba, Ibaraki
TEL 02-853-3843
Homepage URL
Email suzukiyo@hosp.tsukuba.ac.jp

Sponsor
Institute Tsukuba University Hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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
2010 Year 10 Month 02 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
2010 Year 05 Month 14 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 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
2010 Year 10 Month 01 Day
Last modified on
2016 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005167

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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