UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015539 |
|---|---|
| Receipt number | R000017882 |
| Scientific Title | Bioanalysis , Effect and safety of DCV/ASV in hemodialysis patients infected with HCV: Pilot Study |
| Date of disclosure of the study information | 2014/10/28 |
| Last modified on | 2016/12/21 16:42:17 |
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Basic information
Public title
Bioanalysis , Effect and safety of DCV/ASV in hemodialysis patients infected with HCV: Pilot Study
Acronym
PK study of DCV/ASV in hemodialysis patients infected with HCV:
Scientific Title
Bioanalysis , Effect and safety of DCV/ASV in hemodialysis patients infected with HCV: Pilot Study
Scientific Title:Acronym
PK study of DCV/ASV in hemodialysis patients infected with HCV:
Region
| Japan |
Condition
Condition
Chronic hepatitis C in hemodialysis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate pharmacokinetic profile of DCV/ASV in hemodialysis patients infected with HCV.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Caluculated PK parameters such as Cmax, Cmin, Tmax, AUC at 1 week
Key secondary outcomes
sustend virologic response and
virologic response at 1,2,3,4weeks
Safety ( moniterd clinical and laboratory evaluation)
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 | Maneuver |
Interventions/Control_1
The DCV and ASV level in the blood during DCV/ASV dual treatment will be determined in hemodialysis patients infected with HCV.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Hemodialysis patients infected with HCV and expected to survive for more than 5 years
Key exclusion criteria
1) Autoimmune hepatitis
2) History of hypersensitivity to DCV and ASV
3) Decompenstated liver cirrhosis
4) HCC, malignat tumor
5) Pregnant or lactating women and women who may be pregnant
6) Judged by investigator not to be appropriate for inclusion in this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuaki Chayama |
Organization
graduate school of biomedical science, Hiroshima university.
Division name
Department and medicine and molecular science
Zip code
Address
1-2-3 kasumi, minami-ku, Hiroshima 734-8551
TEL
082-257-5190
chayama@mba.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiiku Kawakami |
Organization
graduate school of biomedical science, Hiroshima university
Division name
Department and medicine and molecular science
Zip code
Address
1-2-3 kasumi, minami-ku, Hiroshima 734-8551
TEL
082-257-5190
Homepage URL
kamy4419@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima liver study group
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
広島大学病院（広島県）、広島赤十字原爆病院（広島県）、土谷総合病院（広島県）、聖マリアンナ医科大学病院（神奈川県）、呉医療センター（広島県）、呉共済病院（広島県）、尾道総合病院（広島県）、柳井医療センター（山口県）、県立広島病院（広島県）、三次中央病院（広島県）、山陽病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2014 | Year | 09 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | 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
| 2014 | Year | 10 | Month | 27 | Day |
Last modified on
| 2016 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017882
