UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of efficacy and safety of administration of vitamin D3 with the PEG-IFN alpha 2a/Ribavirin therapy to hepatitis C patients with osteoporosis.
Title of the study (Brief title)	Vitamin D3 with the PEG-IFN alpha 2a/RBV therapy to hepatitis C patients with osteoporosis.
Region	Japan

Condition
Condition	hepatitis C
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the efficacy and safety of administration of vitamin D3 with the PEG-IFN alpha 2a/RBV therapy to hepatitis C patients with osteoporosis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Virological response: the rate of patients negative for serum HCV-RNA after 24 weeks of the end of therapy (SVR: sustained virological response)
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Vitamin D3 (Alfacalcidol) is administered to the patient with osteoporosis in addition to standard treatment of hepatitis C.
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	1.Patient diagnosed as chronic hepatitis C or compensated liver cirrhosis due to HCV 2.Genotype 1 type with high viral load (HCV-RNA 100KIU or more) in chronic hepatitis C 3.No the treatment history are asked. 4.Osteoporosis or the bone mass decreased patient. 3.Patient who obtains agreement for participation in present study.
Key exclusion criteria	1.Pregnant woman or woman who has possibility of pregnancy or woman while suckling 2.Patient who has previous history of hypersensitivity for element of ribavirin or other nucleosides analog (aciclovir, ganciclovir, and vidarabine, etc.) 3.Patient who has heart disease difficult to control (cardiac infarction, cardiac failure, and arrhythmia, etc.) 4.Patient with abnormal haemoglobin syndrome (thalassemia and drepanocytic anemia, etc.) 5.The chronic renal failure or a patient who has the renal dysfunction of CCr 50mL/min or less. 6.Patient who exists in serious state of mental disease of serious depression, thought of suicide or suicide plan, etc. or patient who has the previous history. 7.Patient with serious liver function trouble 8.Patient with autoimmune hepatitis 9.Patient who is administering the sho-sai-ko-to 10.Other chronic liver disease patients such as autoimmune hepatitis or alcoholic hepatitis. 11.Patient who has previous history of hypersensitivity for element of PEG-IFN alpha 2a or other interferon therapy. 12.Patient who has previous history of hypersensitivity for biological products such as vaccines. 13.Patient with cirrhosis, liver failure, and liver carcinoma. 14.Patient who is taking vitamin D3, bisphosphonate, SERM, and vitamin K preparation (Make it to the wash out period on one month or more, of six months or more, of one month or more, of one month or more respectively). 15.Additionally, patient judged by doctor that participation in this study is improper.
Target sample size	20

Research contact person
Name of lead principal investigator	Yasushi Seo
Organization	Kobe University Hospital
Division name	Gastroenterology
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
Email

Public contact
Name of contact person	Yoshihiko Yano
Organization	Kobe University Hospital
Division name	Gastroenterology
Address
TEL
Homepage URL
Email	yanoyo@med.kobe-u.ac.jp

Sponsor
Institute	Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
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	2010 Year 12 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 07 Month 04 Day
Anticipated trial start date	2011 Year 08 Month 01 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	2010 Year 11 Month 27 Day
Last modified on	2017 Year 11 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005522