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
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Tracking Information | |||||
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First Submitted Date ICMJE | April 28, 2017 | ||||
First Posted Date ICMJE | May 9, 2017 | ||||
Results First Submitted Date ICMJE | September 21, 2018 | ||||
Results First Posted Date ICMJE | June 3, 2019 | ||||
Last Update Posted Date | June 3, 2019 | ||||
Actual Study Start Date ICMJE | April 1, 2017 | ||||
Actual Primary Completion Date | December 31, 2017 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT03144635 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study for G1b CHC Patients With CKD-3 Treated With Grazoprevir Plus Elbasvir | ||||
Official Title ICMJE | A Prospective Multicenter Observational Study for Characterization of Renal Function G1b CHC Patients With CKD-3 Treated With Grazoprevir Plus Elbasvir | ||||
Brief Summary | 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. |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 4 | ||||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | 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.
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Study Arms ICMJE | Experimental: Grazoprevir plus Elbasvir
Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.
Intervention: Drug: Grazoprevir plus Elbasvir
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
80 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | September 20, 2018 | ||||
Actual Primary Completion Date | December 31, 2017 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Japan | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03144635 | ||||
Other Study ID Numbers ICMJE | KULDS-001 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Norihiro Furusyo, Kyushu University | ||||
Study Sponsor ICMJE | Kyushu University | ||||
Collaborators ICMJE | Merck Sharp & Dohme Corp. | ||||
Investigators ICMJE |
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PRS Account | Kyushu University | ||||
Verification Date | February 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |