UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An open-label randomized controlled trial to assess the efficacy and safety of chronic hepatitis C and compensated cirrhosis patients with the prescribing pattern of vitaminD plus peginterferon alpha-2a /ribavirin.
Title of the study (Brief title)	The prescribing pattern of vitaminD plus peginterferon alfa-2a/ribavirin for treatment of chronic hepatitis C and compensated cirrhosis patients.
Region	Japan

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

Objectives
Narrative objectives1	An open-label randomized controlled trial to assess the efficacy and safety of chronic hepatitis C and compensated cirrhosis patients with the prescribing pattern of vitaminD plus peginterferon alpha-2a and ribavirin. To assess the 25-OH-D serum concentration and efficacy.
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 terminating therapy.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	VitaminD (2000IU/day) for 4 weeks,vitaminD plus PegIFN alfa-2a(180microgram)weekly plus ribavirin(600-1000mg/day)for 48weeks.Negative result of HCVRNA test at 12-36 weeks for 72weeks treatment(groupA)
Interventions/Control_2	VitaminD (2000IU/day) plus PegIFN alfa-2a(180microgram)weekly plus ribavirin(600-1000mg/day) for 48weeks.Negative results of HCVRNA test at 12-36weeks for 72 weeks treatment (groupB)
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)The following chronic hepatitis C patients were eligible to enter the trial 1) From 18 years old or over 2)Chronic hepatitis C 3)The presence of the liver biopsy is not asked 4) Genotype1a/1b first time treatment is HCV RNA>=5LogIU/mL 5)Genotype2a/2b retreatment 6)Platelet count >=90,000/micro L 7)WBC count>=3,000/micro L. Neutrophil count >=1,500/micro L. Hemoglobin concentration >=12g/dL. 8)Patients who provided written informed consents to participate the study prior to enrollment (2) The following hepatitis C and compensated cirrhosis patients were eligible to enter the trial 1) From 18 years old or over 2)hepatitis C and compensated cirrhosis 3)The presence of the liver biopsy is not asked 4)Platelet count >=75,000/micro L 5)WBC count>=3,000/micro L. Neutrophil count >=1,500/micro L. Hemoglobin concentration >=12g/dL. 6)The presence of the IFN treatment history is not asked 7)Patients who provided written informed consents to participate the study prior to enrollment
Key exclusion criteria	The following patients were excluded 1)Women of childbearing potential and pregnancy, lactating woman 2) allergic to ribavirin or nucleoside analogues 3)an uncontrollable heart trouble (myocardial infarction, heart failure, or arrhythmia) 4)hemoglobinopathy(thalassemia, sickle cell disease) 5) severe renal disease, Ccr <50ml/min 6) severe depression or psychosomatic disorders 7)severe liver disease 8) autoimmune hepatitis or HBV 9) drug allergy against interferon 10) Allergic to vaccine or biological preparations 11) Concomitant herbal medication of Sho-saikoto 12) history of interstitial pneumonia 13) high-dose lipid soluble vitamin agents using patients. 14)Other conditions considered inappropriate by attending physician
Target sample size	80

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-cho,Iruma-gun,Saitama,Japan
TEL	049-276-1198
Email	smochida@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-cho,Iruma-gun,Saitama,Japan
TEL	049-276-1198
Homepage URL
Email	nobunaka@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University
Institute
Department

Funding Source
Organization	None
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	2012 Year 07 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 12 Day
Anticipated trial start date	2012 Year 05 Month 01 Day
Last follow-up date	2016 Year 03 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	2012 Year 07 Month 04 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=R000008946