UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002601
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email hiasa@m.ehime-u.ac.jp

Sponsor
Institute Ehime University Graduate School of Medicine,
Department of Gastroenterology and Metabology
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003156

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.