UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024227 |
|---|---|
| Receipt number | R000027897 |
| Scientific Title | Safety and efficacy of Daclatasvir and Asunaprevir combination therapy for hemodialyzed patients with genotype 1 chronic hepatitis C infection |
| Date of disclosure of the study information | 2016/09/29 |
| Last modified on | 2022/10/06 09:55:21 |
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Basic information
Public title
Safety and efficacy of Daclatasvir and Asunaprevir combination therapy for hemodialyzed patients with genotype 1 chronic hepatitis C infection
Acronym
Daclatasvir and Asunaprevir therapy for hemodialyzed ptatients
Scientific Title
Safety and efficacy of Daclatasvir and Asunaprevir combination therapy for hemodialyzed patients with genotype 1 chronic hepatitis C infection
Scientific Title:Acronym
Daclatasvir and Asunaprevir therapy for hemodialyzed ptatients
Region
| Japan |
Condition
Condition
hemodialyzed patients with genotype 1
chronic hepatitis C infection
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze Safety and efficacy of Daclatasvir and Asunaprevir combination therapy for hemodialyzed patients with chronic hepatitis C infection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sustained virological response
adverse events
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
hemodialyzed patients with genotype 1 chronic hepatitis C, who initiated on dacalatasvir and asunaprevir between November 2014 and march 2016
Key exclusion criteria
1patients with heart failure
2patients with decompensated cirrhosis
3patients with allergic to NS5A inhibitor or HCV PI inhibitor
4 patients with HCC or other malignant disease
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Goki |
| Middle name | |
| Last name | Suda |
Organization
Graduate School of Medicine,Hokkaido University
Division name
Department of Gastroenterology and Hepatology, Graduate School of Medicine
Zip code
065-0010
Address
Kita 14-jo Nishi 5-jo, Kita-ku, Sapporo city, Hokkaid
TEL
011-716-1161
gsudgast@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Goki |
| Middle name | |
| Last name | Suda |
Organization
Hokkaido University
Division name
Department of Gastroenterology and Hepatology, Graduate School of Medicine,
Zip code
065-0010
Address
Kita 14-jo Nishi 5-jo, Kita-ku, Sapporo city, Hokkaid
TEL
011-716-1161
Homepage URL
gsudgast@pop.med.hokudai.ac.jp
Sponsor or person
Institute
others
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
IRB committee of Hokkaido University Hospital
Address
Sapporo city kita ku kita14zyou nishi 5
Tel
0117067061
crjimu@huhp.hokudai.ac.jp
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 | 09 | Month | 29 | 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 | 09 | Month | 29 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Safety and efficacy of Daclatasvir and Asunaprevir combination therapy
Observation and Test Parameters and Methods
The following items will be checked.
Patient characteristics: gender, age, height, liver histology, prior treatments, allergic history, medical history, and any complications Hematological parameters
1Viral factors: HCV NS5A/NS3 inhibitor resistant mutations
2Peripheral blood tests: WBC, differential WBC, Hb, and Plt
3Liver function tests: AST, ALT, GTP, and ALP
4Biochemistry: LDH, BUN, total bilirubin, direct bilirubin, ALP, total protein, albumin, creatinine, Na, K, Cl, amylase, and lipase
5Fibrosis markers: hyaluronic acid, type IV collagen, and AFP
6Glucose tolerance tests:fasting glucose, insulin, and HbA1c; Lipid metabolism: TC, LDL-C, and TG; Blood coagulation: PT-INR
7Viral kinetics: serial measurement of viral load (Taqman-PCR assay)
8IL28B,
9Measurement of liver stiffness by liver biopsy/FibroScan
Management information
Registered date
| 2016 | Year | 09 | Month | 29 | Day |
Last modified on
| 2022 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027897
| 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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