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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008342
Receipt No. 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

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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
Email 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
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)

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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008946

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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