A Study for G1b CHC Patients With CKD-3 Treated With Grazoprevir Plus Elbasvir
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|ClinicalTrials.gov Identifier: NCT03144635|
Recruitment Status : Completed
First Posted : May 9, 2017
Results First Posted : June 3, 2019
Last Update Posted : June 3, 2019
The regimen using grazoprevir plus elbasvir treatment is promising in Japan, because it may safely be used for the elderly patients with renal dysfunction. Grazoprevir and elbasvir are metabolized in the liver and do not require dose-adjustment for patients with renal dysfunction. However, no data related to efficacy and safety of the grazoprevir plus elbasvir treatment for Japanese elderly patients with renal dysfunction (eGFR<60 mL/min/1.73m2) have been reported. Therefore, physicians are at a loss whether or not to treat the patients with renal dysfunction due to no evidence.
The aim of this study is to investigate the improvement of serum endostatin level of Japanese patients with CKD stage 3 after grazoprevir (NS3/4A protease inhibitor) plus elbasvir (NS5A replication complex inhibitor) treatment by a prospective, multicenter cohort study.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Viral Chronic Kidney Disease stage3||Drug: Grazoprevir plus Elbasvir||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Multicenter Observational Study for Characterization of Renal Function G1b CHC Patients With CKD-3 Treated With Grazoprevir Plus Elbasvir|
|Actual Study Start Date :||April 1, 2017|
|Actual Primary Completion Date :||December 31, 2017|
|Actual Study Completion Date :||September 20, 2018|
Experimental: Grazoprevir plus Elbasvir
Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.
Drug: Grazoprevir plus Elbasvir
An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.
- Change of Serum Endostatin Level (ng/mL) From Baseline to 3 Months [ Time Frame: 3 months ]We evaluated the serum endostatin at baseline and 3 months after the treatment initiation.
- Change of eGFR Level (mL/Min/1.73m^2) From Baseline to 3 Months [ Time Frame: 3 months ]We evaluated eGFR level at baseline and 3 months after the treatment initiation.
- Sustained Virological Response-12 (SVR12) [ Time Frame: 3 months ]SVR12 was defined as undetectable HCV RNA at week 12 after the end of treatment.
- Change of Serum Alanine Aminotransferase (ALT) Level (U/L) From Baseline to 3 Months [ Time Frame: 3 months ]We evaluated the serum ALT levels at baseline and 3 months after the treatment initiation.
- Change of Serum Alpha-fetoprotein Level (ng/mL) From Baseline to 3 Months [ Time Frame: 3 months ]We evaluated the serum alpha-fetoprotein levels at baseline and 3 months after the treatment initiation.
- Count of Participants With NS3/4A or NS5A Muttations Who Achieved SVR12 [ Time Frame: 3 months ]We identified the NS3/4A or NS5A muttations by direct sequencing at baseline. Among participants who had mutations, we calcualted the rate of SVR12.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03144635
|Kyushu University Hospital|
|Fukuoka, Japan, 812-8582|
|Principal Investigator:||Norihiro Furusyo, MD, PhD||Kyushu University Hospital|