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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
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Norihiro Furusyo, Kyushu University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hepatitis C Viral Chronic Kidney Disease stage3 Drug: Grazoprevir plus Elbasvir Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Sustained Virological Response-12 (SVR12) [ Time Frame: 3 months ]
    SVR12 was defined as undetectable HCV RNA at week 12 after the end of treatment.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects aged 20 years or older.
  2. Patients positive for HCV RNA for over 6 months and infected with genotype 1b chronic hepatitis C, including compensated cirrhosis.
  3. Patients without co-infection of hepatitis B virus.
  4. Patients without co-infection of human immunodeficiency virus
  5. Patients with moderate chronic kidney disease (CKD stage 3) (eGFR: 30-59 mL/min/1.73m2). A diagnosis of CKD is only confirmed if repeated eGFR tests for at least 90 days.

Exclusion Criteria:

  1. Patients with decompensated cirrhosis (Child Pugh B and C)
  2. Patients with albumin <3.0 g/dL and platelets <75,000 /μL
  3. Patients with autoimmune hepatitis
  4. Constant heavy alcohol drinkers (converted to ethanol ≥60 g/day)
  5. Patients who have a history of hypersensitivity to grazoprevir and elbasvir
  6. Patients who are pregnant females, or females who may become pregnant, or females who are breastfeeding
  7. Patients with heart disease that is hard to control (e.g., very recent cardiac infarction, severe heart failure, unstable arrhythmia)
  8. Patients who are under medication with drugs listed as contraindication in a package insert of grazoprevir plus elbasvir treatment
  9. Patients judged (by the physician in charge of research) to be inappropriate as subjects for the study for any other reasons.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Japan
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Sponsors and Collaborators
Kyushu University
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Norihiro Furusyo, MD, PhD Kyushu University Hospital
  Study Documents (Full-Text)

Documents provided by Norihiro Furusyo, Kyushu University:
Study Protocol and Statistical Analysis Plan  [PDF] September 20, 2018

More Information
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Publications:

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Responsible Party: Norihiro Furusyo, Associate Professor, Department of General Internal Medicine, Kyushu University
ClinicalTrials.gov Identifier: NCT03144635     History of Changes
Other Study ID Numbers: KULDS-001
First Posted: May 9, 2017    Key Record Dates
Results First Posted: June 3, 2019
Last Update Posted: June 3, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norihiro Furusyo, Kyushu University:
Direct Acting Antivirals
Grazoprevir
Elbasvir
Additional relevant MeSH terms:
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Hepatitis C
Kidney Diseases
Renal Insufficiency, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Flaviviridae Infections
RNA Virus Infections
Urologic Diseases
Renal Insufficiency
MK-5172
Antiviral Agents
Anti-Infective Agents