UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Yoichi Hiasa
Organization	Ehime University Graduate School of Medicine
Division name	Department of Gastroenterology and Metabology
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	Yoichi Hiasa
Organization	Ehime University Graduate School of Medicine
Division name	Department of Gastroenterology and Metabology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 09 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000003156