UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024261 |
|---|---|
| Receipt number | R000027843 |
| Scientific Title | Comprehensive analysis of iron and mineral-bone metabolism after HCV clearance by daclatasvir and asunaprevir combination therapy in genotype 1 HCV-infected hemodialysis patients |
| Date of disclosure of the study information | 2016/10/03 |
| Last modified on | 2018/03/05 23:39:54 |
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Basic information
Public title
Comprehensive analysis of iron and mineral-bone metabolism after HCV clearance by daclatasvir and asunaprevir combination therapy in genotype 1 HCV-infected hemodialysis patients
Acronym
Comprehensive analysis of iron and mineral-bone metabolism after HCV clearance by daclatasvir and asunaprevir combination therapy in genotype 1 HCV-infected hemodialysis patients
Scientific Title
Comprehensive analysis of iron and mineral-bone metabolism after HCV clearance by daclatasvir and asunaprevir combination therapy in genotype 1 HCV-infected hemodialysis patients
Scientific Title:Acronym
Comprehensive analysis of iron and mineral-bone metabolism after HCV clearance by daclatasvir and asunaprevir combination therapy in genotype 1 HCV-infected hemodialysis patients
Region
| Japan |
Condition
Condition
genotype 1 HCV patients receiving hemodialysis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we aim at examining the effect on iron and mineral-bone metabolism after HCV clearance by daclatasvir and asunaprevir combination therapy in genotype 1 HCV-infected hemodialysis patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare erythropoietic resistance index change between pre and post of treatment in the early intervention group and waiting intervention group
Key secondary outcomes
To assess Iron metabolism kinetics
To assess mineral-bone metabolism kinetics
To assess antiviral activity, the proportion of subjects who achieve undetectable HCV RNA at post treatment week 12
To assess safety
To assess CLDQ-HCV, KDQOL-SF
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The subjects will be randomly assigned to the early intervention group and waiting intervention group. After entry in the study, the early intervention group will orally receive ASV 100 mg per dose twice daily and DCV 60 mg once daily for 24 weeks. After this treatment, the subjects will be observed for a further 24 week period.
Interventions/Control_2
The waiting intervention group will wait for the first 24 weeks and then receive the ASV/DCV combination therapy.
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
1)20 years old or older
2)Genotype 1 HCV -infected patients receiving hemodialysis
3)Patients who were provided with sufficient explanation before participating in this study and who provided written consent to participate in this study on their own free will.
Key exclusion criteria
1)Patients with decompensated cirrhosis
2)Patients complicated with hepatic cancer
3)Other patients whom the chief investigator or a sub-investigators considers inappropriate
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Arase |
Organization
Tokai University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
shimokasuya 143, Isehara, Kanagawa, Japan
TEL
0463-93-1121
arase@tokai-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Arase |
Organization
Tokai University Oiso Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Gakkyo 21-1, Oisotyo, Nakagun, Kanagawa, Japan
TEL
0463-72-3211
Homepage URL
arase@tokai-u.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Bristol-Myers Squibb
Organization
Division
Category of Funding Organization
Profit organization
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
東海大学医学部付属病院
東海大学医学部付属大磯病院
東海大学医学部付属八王子病院
東海大学医学部付属東京病院
帝京大学医学部付属病院
順天堂大学医学部付属順天堂医院
順天堂大学医学部付属練馬病院
医療法人社団 松和会 池上総合病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 03 | 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
| 2016 | Year | 06 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | 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
| 2016 | Year | 10 | Month | 03 | Day |
Last modified on
| 2018 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027843
