UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of simeprevir/pegylated-interferon/ribavirin combination therapy with Vitamin D3 in chronic hepatitis C patients: multi-center, open label, randomized, controlled study
Title of the study (Brief title)	Simeprevir/peg-interferon/ribavirin combination therapy with or without Vitamin D3
Region	Japan

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

Objectives
Narrative objectives1	To confirm the efficacy and safety of simeprevir/peg-interferon/ribavirin combination therapy with Vitamin D3 in chronic hepatitis C patients with IL28B minor genotype.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Sustained virological response rate
Key secondary outcomes	Safety and HCV-RNA dynamics

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Food
Interventions/Control_1	Simeprevir/pegylated-interferon/ribavirin combination therapy with Vitamin D3 for 24weeks
Interventions/Control_2	Simeprevir/pegylated-interferon/ribavirin combination therapy without Vitamin D3 for 24weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	Patient with HCV RNA high viral load (>5.0 log IU/mL) as determined by quantitative analysis with real-time polymerase chain reaction (PCR), infection with HCV genotype 1b, IL28B (rs8099917) minor genotype (TG or GG), white blood cell (WBC) count > 2,000/mm3, neutrophil count > 1,500/mm3, platelet count > 80,000/mm3, and hemoglobin concentration > 11.0 g/dl.
Key exclusion criteria	1. other liver diseases, including autoimmune hepatitis, primary biliary cirrhosis, and alcoholic disease 2. positive result for hepatitis B surface antigen and antibody to human immunodeficiency virus type-1 3. decompensated liver cirrhosis 4. severe renal disorder 5. pregnant woman or lactating mother 6. allergy to IFN, ribavirin, protease inhibitor or biological preparations such as vaccines. 7. poorly controlled diabetes; poorly controlled heart failure;poorly controlled hypertension 8. medication with Chinese herbal medicine 9. medical history of interstitial pneumonia 10. severe depression 11. hyperparathyroidism 12. hypercarcemia 13. medication with other vitamin D preparations
Target sample size	150

Research contact person
Name of lead principal investigator	Masanori Atsukawa
Organization	Nippon Medical School Chiba Hokusoh Hospital
Division name	Division of Gastroenterology
Address	1715 Kamakari, Inzai, Chiba, 270-1694, Japan
TEL	0476-99-1111
Email	atsukawa-nms@umin.ac.jp

Public contact
Name of contact person	Masanori Atsukawa
Organization	Nippon Medical School Chiba Hokusoh Hospital
Division name	Division of Gastroenterology
Address	1715 Kamakari, Inzai, Chiba, 270-1694, Japan
TEL	0476-99-1111
Homepage URL
Email	atsukawa-nms@umin.ac.jp

Sponsor
Institute	Nippon Medical School Chiba Hokusoh Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	None

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	2014 Year 01 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 09 Day
Anticipated trial start date	2013 Year 12 Month 09 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 01 Month 30 Day
Last modified on	2016 Year 07 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015196