UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004210 |
|---|---|
| Receipt number | 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 09:50:05 |
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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
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
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005058
