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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026542
Receipt No. R000030481
Scientific Title A prospective multicenter study for characterization of renal function G1b CHC patients with CKD-3 treated with elbasvir plus grazoprevir
Date of disclosure of the study information 2017/03/14
Last modified on 2019/03/01

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Basic information
Public title A prospective multicenter study for characterization of renal function G1b CHC patients with CKD-3 treated with elbasvir plus grazoprevir
Acronym Elbasvir plus grazoprevir treatment for patients with G1b CHC patients with CKD-3
Scientific Title A prospective multicenter study for characterization of renal function G1b CHC patients with CKD-3 treated with elbasvir plus grazoprevir
Scientific Title:Acronym Elbasvir plus grazoprevir treatment for patients with G1b CHC patients with CKD-3
Region
Japan

Condition
Condition Genotype 1b chrinic hepatitis C patients with CKD-3
Classification by specialty
Hepato-biliary-pancreatic medicine Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of elbasvir plus grazoprevir in patients infected with HCV genotype 1b.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of sustained viral response.
Key secondary outcomes (1)Transition of renal function
(2)Safety(the rate of discontinuation)
(3)Biochemical efficacy

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 Treatment of elbasvir plus grazoprevir
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 who are infected with HCV genotype 1b
2.Patients with moderate chronic kidney disease (CKD stage 3)
Key exclusion criteria 1.Decompensated liver cirrhosis (Child Pugh B/C)
2.Patients with co-infection with HBV or HIV
3.Patients who are pregnant females, or females who may become pregnant
4.Patients who are under medication with drugs listed as contraindication in a package insert
5.Patients judged to be inappropriate as subjects for the study
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiro Furusyo
Organization Kyushu University Hospital
Division name Department of General Internal Medicine
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL 092-642-5909
Email furusyo@gim.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiichi Ogawa
Organization Kyushu University Hospital
Division name Department of General Internal Medicine
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL 092-642-5909
Homepage URL
Email eogawa@gim.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University
Institute
Department

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
Email

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 03 Month 14 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
The overall sustained viral response (SVR) rates in the per protocol populations were 98.7% (76/77). High SVR12 rates were observed in almost all subgroups, including older age (over 75 years), cirrhosis, and history of HCC. There was no significant change during treatment or follow-up period in estimated glomerular filtration rate and endostatin level. In contrast, the serum complement level (C3 and C4) increased, with significance for C3. Serious adverse effects were very rare, and discontinuation was required for only two (2.5%) patients due to the ALT elevation during the second half of treatment.
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
2017 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 08 Month 15 Day

Other
Other related information We published the real-world cohort study consisted of 282 Japanese patients who were treated with elbasvir plus grazoprevir, including the data of 80 patients with CKD stage 3.

Management information
Registered date
2017 Year 03 Month 14 Day
Last modified on
2019 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030481

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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