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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009057
Receipt No. R000010631
Scientific Title A study on appetite loss in chronic hepatitis C patients terated with telaprevir, ribavirin and PEG-IFN.
Date of disclosure of the study information 2012/10/26
Last modified on 2019/04/14

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Basic information
Public title A study on appetite loss in chronic hepatitis C patients terated with telaprevir, ribavirin and PEG-IFN.
Acronym A study on appetite loss in chronic hepatitis C patients during IFN treatment.
Scientific Title A study on appetite loss in chronic hepatitis C patients terated with telaprevir, ribavirin and PEG-IFN.
Scientific Title:Acronym A study on appetite loss in chronic hepatitis C patients during IFN treatment.
Region
Japan

Condition
Condition chronic hepatitis C
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to clarify the relationship between appetite loss and grelin
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes serum ghrelin level
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
Maneuver
Interventions/Control_1 blood collection
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria chronic hepatitis C patients treated with telaprevir, ribavirin and PEGIFN
Key exclusion criteria none
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Koji
Middle name
Last name Yakabi
Organization Saitama Medical University, Saitama Medical Center
Division name Dept. of Gastroenterology and Hepatology
Zip code 350-8550
Address 1981 Kamoda Kawagoe-shi
TEL 049-228-3564
Email kjyakabi@saitama-med.ac.jp

Public contact
Name of contact person
1st name Sumiko
Middle name
Last name Nagoshi
Organization Saitama Medical University, Saitama Medical Center
Division name Dept. of Gastroenterology and Hepatology
Zip code 350-8550
Address 1981 Kamoda Kawagoe-shi
TEL 049-228-3564
Homepage URL
Email snagoshi@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medical University, Saitama Medical center
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 Saitama Medical Center,
Address 1981 Kamoda, Kawagoe-shi, Saitama
Tel 049-228-3902
Email smcrinri@saitama-med.ac.jp

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 10 Month 26 Day

Related information
URL releasing protocol
Publication of results Partially 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 No longer recruiting
Date of protocol fixation
2012 Year 04 Month 01 Day
Date of IRB
2012 Year 10 Month 27 Day
Anticipated trial start date
2012 Year 10 Month 27 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
2015 Year 09 Month 30 Day
Date trial data considered complete
Date analysis concluded
2015 Year 10 Month 13 Day

Other
Other related information

Management information
Registered date
2012 Year 10 Month 06 Day
Last modified on
2019 Year 04 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010631

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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