UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025784 |
|---|---|
| Receipt number | R000029655 |
| Scientific Title | Safety and efficacy of Grazoprevir and Elbasvir combination therapy for hemodialyzed patients with genotype 1 chronic hepatitis C infection |
| Date of disclosure of the study information | 2017/01/21 |
| Last modified on | 2020/01/24 12:38:42 |
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Basic information
Public title
Safety and efficacy of Grazoprevir and Elbasvir combination therapy for hemodialyzed patients with genotype 1 chronic hepatitis C infection
Acronym
Grazoprevir/Elbasvir therapy for hemodialyzed patients
Scientific Title
Safety and efficacy of Grazoprevir and Elbasvir combination therapy for hemodialyzed patients with genotype 1 chronic hepatitis C infection
Scientific Title:Acronym
Grazoprevir/Elbasvir therapy for hemodialyzed patients
Region
| Japan |
Condition
Condition
hemodialyzed patients with 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 Grazoprevir/Elbasvir 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
Observational
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 Grazoprevir/Elbasvir and asunaprevir between January 2017 and march 2019
Key exclusion criteria
1 Patients with a past history of hypersensitivity to HCV protease inhibitors and NS5A inhibitors
2 Patients with serious liver dysfunction (Child-Pugh Class B or C)
3 Patients with difficult-to-control heart disease (e.g., myocardial infarction, heart failure, and arrhythmia)
4 Patients who have malignant tumors, including hepatoma, at the start of treatment
5 Patients on treatment with drugs listed in the contraindications for coadministration in the package insert (e.g., some antifungals, some antiepileptics, and human immunodeficiency virus (HIV) protease inhibitors)
6 Patients with albumin <3.0 g/dL
7 Other patients judged to be inappropriate to participate in the study by the primary physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Goki Suda |
Organization
Graduate School of Medicine,
Hokkaido University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
North 15, West 7, Kita-ku, Sapporo, Hokkaido
TEL
011-716-2111
gsudgast@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Goki Suda |
Organization
Graduate School of Medicine, Hokkaido University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
North 15, West 7, Kita-ku, Sapporo, Hokkaido
TEL
011-716-2111
Homepage URL
gsudgast@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Graduate School of Medicine,
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
MSD K.K
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 21 | 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 | 01 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1 Viral factors: HCV NS5A/NS3 inhibitor resistant mutations
2 Peripheral blood tests WBC, differential WBC, Hb, and Plt
3 Liver function tests AST, ALT, GTP, and ALP
4 Biochemistry LDH, BUN, total bilirubin, direct bilirubin, ALP, GTP, total protein, albumin, creatinine, Na, K, Cl, amylase, and lipase
5 Fibrosis markers hyaluronic acid, type collagen, and AFP
6 Glucose tolerance tests: fasting glucose, insulin, and HbA1c; Lipid metabolism: TC, LDL-C, and TG; Blood coagulation
7 Viral kinetics: serial measurement of viral load
8 IL28B
9 Measurement of liver stiffness by liver biopsy/FibroScan
Management information
Registered date
| 2017 | Year | 01 | Month | 21 | Day |
Last modified on
| 2020 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029655
