UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022563 |
|---|---|
| Receipt number | R000025872 |
| Scientific Title | The efficacy of paritaprevir and ombitasvir with a booster dose of ritonavir in genotype 1 HCV patients with hemodialysis |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2016/06/01 08:33:03 |
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Basic information
Public title
The efficacy of paritaprevir and ombitasvir with a booster dose of ritonavir in genotype 1 HCV patients with hemodialysis
Acronym
Viek-tory HD study
Scientific Title
The efficacy of paritaprevir and ombitasvir with a booster dose of ritonavir in genotype 1 HCV patients with hemodialysis
Scientific Title:Acronym
Viek-tory HD study
Region
| Japan |
Condition
Condition
hemodialysis patients chronically infected with genotype 1 hepatitis C virus
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of paritaprevir and ombitasvir with a booster dose of ritonavir in a prospective study of genotype 1 HCV patients with hemodialysis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
antiviral effect (24 weeks after end of administration)
Key secondary outcomes
1) antiviral effect (4 weeks after end of administration)
2) the improvement of liver function at the end of treatment
3) adverse events
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
administration of paritaprevir and ombitasvir with a booster of ritonavir for 12 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patients with written consent of this study
2) patients infected with HCV genotype 1 with chronic hepatitis or with compensated cirrhosis
3) patients without contraindications to paritaprevir, ombitasvir, or ritonavir.
Key exclusion criteria
1) patients who are allergic to paritaprevir, ombitasvir, or ritonavir.
2) patients with decompensated cirrhosis (Child-Pugh Class B or C)
3) pregnant women and women suspected of being pregnant
4) patients ineligible for some other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takamasa Ohki |
Organization
Mitsui Memorial Hospital
Division name
Department of Gastroenterology
Zip code
Address
1, Kandaizumi-cho, Chiyoda-ku, Tokyo
TEL
03-3862-9111
anb72547@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takamasa Ohki |
Organization
Mitsui Memorial Hospital
Division name
Department of Gastroenterology
Zip code
Address
1, Kandaizumi-cho, Chiyoda-ku, Tokyo
TEL
03-3862-9111
Homepage URL
anb72547@nifty.com
Sponsor or person
Institute
Mitsui Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2016 | Year | 06 | Month | 01 | 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
Date of protocol fixation
| 2016 | Year | 04 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | 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 | 06 | Month | 01 | Day |
Last modified on
| 2016 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025872
