UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010812 |
|---|---|
| Receipt number | R000012080 |
| Scientific Title | A study of interferon beta/ ribavirin plus non-activated vitamin D combination therapy for chronic hepatitis C and decompensated cirrhosis patients. |
| Date of disclosure of the study information | 2013/05/27 |
| Last modified on | 2018/09/21 09:48:45 |
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Basic information
Public title
A study of interferon beta/ ribavirin plus non-activated vitamin D combination therapy for chronic hepatitis C and decompensated cirrhosis patients.
Acronym
Interferon beta with/without ribavirin plus non-activated vitamin D combination therapy for chronic hepatitis C and decompensated cirrhosis patients.
Scientific Title
A study of interferon beta/ ribavirin plus non-activated vitamin D combination therapy for chronic hepatitis C and decompensated cirrhosis patients.
Scientific Title:Acronym
Interferon beta with/without ribavirin plus non-activated vitamin D combination therapy for chronic hepatitis C and decompensated cirrhosis patients.
Region
| Japan |
Condition
Condition
Chronic hepatitis C patients and compensated cirrhosis patients
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To verify whether can be improved therapeutic effect by the combined use of non-activated vitamin D to IFN beta or IFN beta / RBV, for chronic hepatitis C and compensated cirrhosis patients.
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 therapy.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
Chronic hepatitis C with high viral load:
Vitamin D(2000IU/day)for 4 weeks, vitamin D, IFN-beta(6 MIU)and ribavirin(600-1000mg/day)for 48 weeks. Negative result of HCV RNA test at 12-36 weeks for 72 weeks treatment.
HCV serogroup 2 patients were treatment for 24 weeks.
Chronic hepatitis C with low viral load :retreatment patients:
Vitamin D(2000IU/day)for 4 weeks, vitamin D, IFN-beta(6 MIU) and ribavirin(600-1000mg/day)for 24 weeks.
Chronic hepatitis C with low viral load:naive patients:
Vitamin D(2000IU/day)for 4 weeks, vitamin D and IFN-beta(6 MIU) for 8-24 weeks.
Compensated cirrhosis patients:
Vitamin D(2000IU/day)for 4 weeks, vitamin D and IFN-beta(6 MIU) for 36 weeks.
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Chronic hepatitis C and compensated cirrhosis patients with serogroup 1 and low viral load, with serogroup 2.
Key exclusion criteria
pregnant women and nursing mothers
Target sample size
60
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-machi,Iruma-gun,Saitama,Japan
TEL
049-276-1111
hirb@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-machi,Iruma-gun,Saitama,Japan
TEL
049-276-1111
Homepage URL
hirb@saitama-med.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 27 | 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
| 2013 | Year | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 27 | 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=R000012080
