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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000004210
Receipt No. R000005058
Scientific Title 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.
Date of disclosure of the study information 2010/09/17
Last modified on 2018/09/21

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Basic information
Public title 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.
Acronym Vitamin D or Alfacalcidol with peginterferon alfa-2a plus ribavirin for treatment of chronic hepatitis C patients
Scientific Title 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.
Scientific Title:Acronym 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
1st name
Middle name
Last name Satoshi Mochida
Organization Saitama Medical University
Division name Division of Gastroenterology and Hepatology,internal Medicine
Zip code
Address 38,Morohongou,Moroyama-cho,Iruma-gun,Saitama,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Nobuaki Nakayama
Organization Saitama Medical University
Division name Division of Gastroenterology and Hepatology,internal Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://onlinelibrary.wiley.com/doi/epdf/10.1111/jgh.12949
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2010 Year 09 Month 15 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000005058

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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