UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007070 |
|---|---|
| Receipt number | R000007303 |
| Scientific Title | The beneficial effect and safety Eldecalcitol with combined peginterferon alpha-2a plus ribavirin for chronic hepatitis C patients with osteoporosis |
| Date of disclosure of the study information | 2015/03/31 |
| Last modified on | 2014/01/17 19:50:08 |
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Basic information
Public title
The beneficial effect and safety Eldecalcitol with combined peginterferon alpha-2a plus ribavirin for chronic hepatitis C patients with osteoporosis
Acronym
CHALLENGE A plus trial
Scientific Title
The beneficial effect and safety Eldecalcitol with combined peginterferon alpha-2a plus ribavirin for chronic hepatitis C patients with osteoporosis
Scientific Title:Acronym
CHALLENGE A plus trial
Region
| Japan |
Condition
Condition
Chronic hepatitis C with osteoporosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of efficacy and safety of administration of Eldecalcitol with the Peginterferon alpha 2a/Ribavirin therapy to chronic hepatitis C patients with osteoporosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sustained Virological Response ( SVR )
Key secondary outcomes
ALT normalization
Safety
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 |
Interventions/Control_1
Peginterferon alpha 2a
Ribavirin
Eldecalcitol
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The following chronic hepatitis C patients with Genotype 1 and high viral lord were eligible to enter the trial
1. Osteoporosis
2. HCV-RNA>=5.0 LogIU/mL
3. WBC counts>=3,000/microL
4. Neutrophil counts>=1,500/microL
5. Hemoglobin concentration>=12g/dL
6. Platelet counts>=90,000/microL
7. the presense of liver biopsy is not asked
8. the presense of the IFN treatment history is not asked patients who provided written informed consent to participate the study prior to enrollment
Key exclusion criteria
The following patients were excluded
1. women of childbearing potential and pregnancy, lactating women
2. allergic to ribavirin or other nucleoside analoges
3. an uncontrollable heart trouble( myocardial infarction, heart failure, or arrhythmia)
4. hemoglobibopathy ( thalassemia, sickle cell disease)
5. severe renal disease or Ccr<50mL/min
6. severe depression or psychosomatic disorders
7. severe liver diseases
8. autoimmune hepatitis or HBV
9. drug allegy against interferon
10. allergic to vaccine or biological preperations
11. concomitant herbal medication of Sho-saiko-to
13. history of interstitial pneumonia
14. patients who take active vitamin D3 other than Eldecalcitol
15. other conditions considerd
inappropriate by attending physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiro Tamori |
Organization
Osaka City University, Graduate School of Medicine,
Division name
Dept. of Hepatology
Zip code
Address
1-4-3, Asahimachi, Abeno-ku, Osaka
TEL
06-6645-3811
atamori@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Tamori |
Organization
Osaka City University, Graduate School of Medicine,
Division name
Dept. of Hepatology
Zip code
Address
1-4-3, Asahimachi, Abeno-ku, Osaka 545-8585, JAPAN
TEL
06-6645-3435
Homepage URL
webmaster@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Hepatology, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka City 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
大阪市立大学医学部付属病院、大阪市立総合医療センター、大阪市立十三市民病院、
和泉市立病院、大野記念病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 31 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 07 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 30 | 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 | 01 | Month | 16 | Day |
Last modified on
| 2014 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007303
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
