UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009057 |
|---|---|
| Receipt number | 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 | 2023/04/15 12:45:09 |
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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
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
snagoshi@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
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
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
http://www.kawagoe.saitama-med.ac.jp/
Publication of results
Unpublished
Result
URL related to results and publications
http://www.kawagoe.saitama-med.ac.jp/
Number of participants that the trial has enrolled
10
Results
In patients on telaprevir-based therapy, appetite and plasma acyl ghrelin levels decreased significantly on day 1 or 2 compared with those before therapy.
Results date posted
| 2023 | Year | 04 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients with hepatitis C virus
Participant flow
The subjects were 20 Japanese chronic hepatitis patients with HCV genotype 1b infection who were recruited at Saitama Medical Center, Saitama Medical University, between October 2012 and April 2014.
Adverse events
none
Outcome measures
appetite and plasma acyl ghrelin level
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
| 2023 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010631
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
