UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of interferon beta/ ribavirin plus non-activated vitamin D combination therapy for chronic hepatitis C and decompensated cirrhosis patients.
Title of the study (Brief title)	Interferon beta with/without ribavirin plus non-activated vitamin D combination therapy for chronic hepatitis C and decompensated cirrhosis patients.
Region	Japan

Condition
Condition	Chronic hepatitis C patients and compensated cirrhosis patients
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To verify whether can be improved therapeutic effect by the combined use of non-activated vitamin D to IFN beta or IFN beta / RBV, for chronic hepatitis C and compensated cirrhosis patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Negative result of HCV RNA test at 24 weeks after therapy.
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	Treatment
Type of intervention	Medicine Food
Interventions/Control_1	Chronic hepatitis C with high viral load: Vitamin D(2000IU/day)for 4 weeks, vitamin D, IFN-beta(6 MIU)and ribavirin(600-1000mg/day)for 48 weeks. Negative result of HCV RNA test at 12-36 weeks for 72 weeks treatment. HCV serogroup 2 patients were treatment for 24 weeks. Chronic hepatitis C with low viral load :retreatment patients: Vitamin D(2000IU/day)for 4 weeks, vitamin D, IFN-beta(6 MIU) and ribavirin(600-1000mg/day)for 24 weeks. Chronic hepatitis C with low viral load:naive patients: Vitamin D(2000IU/day)for 4 weeks, vitamin D and IFN-beta(6 MIU) for 8-24 weeks. Compensated cirrhosis patients: Vitamin D(2000IU/day)for 4 weeks, vitamin D and IFN-beta(6 MIU) for 36 weeks.
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 and compensated cirrhosis patients with serogroup 1 and low viral load, with serogroup 2.
Key exclusion criteria	pregnant women and nursing mothers
Target sample size	60

Research contact person
Name of lead principal investigator	Satoshi Mochida
Organization	Saitama Medical University
Division name	Division of Gastroenterology and Hepatology ,internal Medicine
Address	38,Morohongou,Moroyama-machi,Iruma-gun,Saitama,Japan
TEL	049-276-1111
Email	hirb@saitama-med.ac.jp

Public contact
Name of contact person	Nobuaki Nakayama
Organization	Saitama Medical University
Division name	Division of Gastroenterology and Hepatology ,internal Medicine
Address	38,Morohongou,Moroyama-machi,Iruma-gun,Saitama,Japan
TEL	049-276-1111
Homepage URL
Email	hirb@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University
Institute
Department

Funding Source
Organization	Saitama Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	2013 Year 05 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 13 Day
Anticipated trial start date	2013 Year 05 Month 13 Day
Last follow-up date
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	2013 Year 05 Month 27 Day
Last modified on	2018 Year 09 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012080