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 patients with vitaminD plus peginterferon alpha-2a /ribavirin.versus alfacalcidol plus peginterferon alpha-2a /ribavirin.
Title of the study (Brief title)	Vitamin D or Alfacalcidol with peginterferon alfa-2a plus ribavirin for treatment of chronic hepatitis C patients
Region	Japan

Condition
Condition	Chronic hepatitis C patients with genotype 1 and high viral load (>= 5 Log IU/mL)
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy and safety of chronic hepatitis C patients treatment with vitaminD plus peginterferon alpha-2a /ribavirin versus alfacalcidol plus peginterferon alpha-2a /ribavirin.
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
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

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	Alfacalcidol(0.5microgram/day) for 4weeks,alfacalcidol(0.5microgram/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	The following chronic hepatitis C patients with serogroup 1 and high viral load 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)HCV RNA>=5LogIU/mL 5)Platelet count >=90,000/micro L 6)WBC count>=3,000/micro L. Neutrophil count >=1,500/micro L. Hemoglobin concentration >=12g/dL. 7)The presence of the IFN treatment history is not asked 8)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)Other conditions considered inappropriate by attending physician
Target sample size	40

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
Email

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
Homepage URL
Email

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	さいたま赤十字病院（埼玉県）、秩父病院（埼玉県）、上尾中央総合病院（埼玉県）、埼玉医科大学総合医療センター（埼玉県）、済生会栗橋病院（埼玉県）、青木病院（埼玉県）、済生会川口総合病院（埼玉県）、国立病院機構埼玉病院（埼玉県）、朝霞台中央総合病院（埼玉県）、戸田中央総合病院（埼玉県）自治医科大学付属さいたま医療センター（埼玉県）、関越病院（埼玉県）

Other administrative information
Date of disclosure of the study information	2010 Year 09 Month 17 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2010 Year 09 Month 15 Day
Anticipated trial start date	2010 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2014 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://onlinelibrary.wiley.com/doi/epdf/10.1111/jgh.12949
Results
Other related information

Management information
Registered date	2010 Year 09 Month 15 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=R000005058