UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002601 |
|---|---|
| Receipt number | R000003156 |
| Scientific Title | Phase I/II clinical trials using hepatitis C virus peptide with the combination therapy of interferon and ribavirin for the patient with chronic hepatitis C |
| Date of disclosure of the study information | 2009/11/01 |
| Last modified on | 2017/10/15 10:50:13 |
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Basic information
Public title
Phase I/II clinical trials using hepatitis C virus peptide with the combination therapy of interferon and ribavirin for the patient with chronic hepatitis C
Acronym
Hepatitis C virus (HCV) peptide immune therapy for the patient with chronic hepatitis C
Scientific Title
Phase I/II clinical trials using hepatitis C virus peptide with the combination therapy of interferon and ribavirin for the patient with chronic hepatitis C
Scientific Title:Acronym
Hepatitis C virus (HCV) peptide immune therapy for the patient with chronic hepatitis C
Region
| Japan |
Condition
Condition
chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
THe aim of this trial is to identify the enhancing efficacy by the hepatitis C virus peptide with interferon and ribavirin for the patients with chronic hepatitis C.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
The ratio of sustained viral response for hepatitis C virus, the ratio of rapid viral response for hepatitis C virus, the ratio of early viral response for hepatitis C virus.
Key secondary outcomes
The frequency of adverse events.
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
Treatment
Type of intervention
| Medicine | Vaccine |
Interventions/Control_1
HCV peptide and its adjuvant are injected in subcutaneous, once per week, for 48 weeks. At the same time, the combination therapy of peg-interferon and ribavirin are treated.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
HLA typing is HLA-A*2402, 0201, 0206.
20-70 years old.
Hepatitis C virus carrier and suffered with chronic hepatitis C.
The patient who agreed to enter the trial with the written document.
The patients who are considered suitable to enter the trial by the responsible medical doctor.
Key exclusion criteria
The patient who has allergy for interferon or ribavirin or other vaccines.
Pregnant patients.
The patients with autoimmune diseases.
The patients with depression.
The patients with diabetes mellitus and hypertension.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoichi Hiasa |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
Address
Shitsukawa, Toon, Ehime 791-0295, Japan
TEL
+81-89-960-5308
hiasa@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoichi Hiasa |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
Address
Shitsukawa, Toon, Ehime 791-0295, Japan
TEL
+81-89-960-5308
Homepage URL
hiasa@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University Graduate School of Medicine,
Department of Gastroenterology and Metabology
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Ehime University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | 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
Completed
Date of protocol fixation
| 2009 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 08 | Day |
Last modified on
| 2017 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003156
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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