UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026542 |
|---|---|
| Receipt number | 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 23:08:12 |
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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
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
eogawa@gim.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu 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 | 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030481
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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