UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008342 |
|---|---|
| Receipt number | R000008946 |
| Scientific Title | 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. |
| Date of disclosure of the study information | 2012/07/05 |
| Last modified on | 2018/09/21 09:47:14 |
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Basic information
Public title
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.
Acronym
The prescribing pattern of vitaminD plus peginterferon alfa-2a/ribavirin for treatment of chronic hepatitis C and compensated cirrhosis patients.
Scientific Title
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.
Scientific Title:Acronym
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
| 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
049-276-1198
smochida@saitama-med.ac.jp
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
049-276-1198
Homepage URL
nobunaka@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
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
Completed
Date of protocol fixation
| 2012 | Year | 04 | Month | 12 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008946
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