UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003865 |
|---|---|
| Receipt number | R000004650 |
| Scientific Title | peginterferon plus ribavirin and glutamine therapy against chronic hepatitis C |
| Date of disclosure of the study information | 2010/08/01 |
| Last modified on | 2023/07/14 09:17:33 |
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Basic information
Public title
peginterferon plus ribavirin and glutamine therapy against chronic hepatitis C
Acronym
IFN + glutamine therapy
Scientific Title
peginterferon plus ribavirin and glutamine therapy against chronic hepatitis C
Scientific Title:Acronym
IFN + glutamine therapy
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of peginterferon plus ribavirin and glutamine therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Sustained virological response or non-response
Key secondary outcomes
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
peginterferon plus ribavirin and oral administration of glutamine
Interventions/Control_2
peginterferon plus ribavirin
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
| 15 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
genotype 1b and high viral load (greater than 5.0LogIU/mL)
Key exclusion criteria
liver cirrhosis
autoimmune hepatitis
primary biliary cirrhosis
malignancy
depression
drug abuse
pregnant or lactating woman
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshimichi Haruna |
Organization
Osaka Prefectural General Medical Center
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
3-1-56 Bandaihigashi, Sumiyoshiku, Osaka 558-8558
TEL
06-6692-1201
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshimichi Haruna |
Organization
Osaka Prefectural General Medical Center
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
TEL
Homepage URL
apple-123-grape@ab.auone-net.jp
Sponsor or person
Institute
Osaka Prefectural General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Osaka Prefectural General 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
Address
Tel
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
大阪府立急性期・総合医療センタ－（大阪府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 08 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2010 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 07 | Month | 03 | Day |
Last modified on
| 2023 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004650
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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