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Trial record 3 of 82 for:    GRAZOPREVIR ANHYDROUS AND ELBASVIR

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

Tracking Information
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
 (submitted: February 18, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 4, 2017)
  • Renal function at 12 weeks after the treatment [ Time Frame: 3 months ]
    Change of serum endostatin level (ng/mL) from baseline
  • Renal function at 12 weeks after the treatment [ Time Frame: 3 months ]
    Change of serum eGFR level (mL/min/1.73m^2) from baseline
Change History Complete list of historical versions of study NCT03144635 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2017)
  • Sustained Virological Response-12 (SVR12) [ Time Frame: 3 months ]
    Serum HCV RNA (logIU/mL) at 12 weeks after the completion of administration
  • Biochemical effect [ Time Frame: 6 months ]
    Change of serum alanine aminotransferase (ALT) level (U/L) from baseline
  • Biochemical effect [ Time Frame: 6 months ]
    Change of serum alpha-fetoprotein level (ng/mL) from baseline
  • Biochemical effect [ Time Frame: 6 months ]
    Change of total cholesterol level (mg/dL) from baseline
  • Adverse effects [ Time Frame: 6 months ]
    Rate of discontinuation (%)
  • Adverse effects [ Time Frame: 6 months ]
    Rate of ALT abnormality (%)
  • Adverse effects [ Time Frame: 6 months ]
    Other important medical events
  • Relationship between SVR12 and drug resistance mutations in NS3/4A and NS5A regions of HCV genome [ Time Frame: 3 months ]
    Drug resistance of HCV genome
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.

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
Condition  ICMJE
  • Hepatitis C Viral
  • Chronic Kidney Disease stage3
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.
Study Arms  ICMJE Experimental: Grazoprevir plus Elbasvir
Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.
Intervention: Drug: Grazoprevir plus Elbasvir
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 4, 2017)
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:

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Norihiro Furusyo, Kyushu University
Study Sponsor  ICMJE Kyushu University
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Principal Investigator: Norihiro Furusyo, MD, PhD Kyushu University Hospital
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