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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024227
Receipt No. 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 2020/04/02

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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
Email 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
Email gsudgast@pop.med.hokudai.ac.jp

Sponsor
Institute others
Institute
Department

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
Email 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 No longer recruiting
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
2020 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027897

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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