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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 Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hepatitis C Viral
Chronic Kidney Disease stage3
Intervention Drug: Grazoprevir plus Elbasvir
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Grazoprevir Plus Elbasvir
Hide Arm/Group Description

Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.

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.

Period Title: Overall Study
Started 80
Completed 0
Not Completed 80
Arm/Group Title Grazoprevir Plus Elbasvir
Hide Arm/Group Description

Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.

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.

Overall Number of Baseline Participants 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 80 participants
77
(69 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants
Female 48
Male 32
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants
American Indian or Alaska Native
0
   0.0%
Asian
80
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Japan Number Analyzed 80 participants
80
 100.0%
Body mass index  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 80 participants
23.3
(20.7 to 25.2)
Albumin  
Median (Inter-Quartile Range)
Unit of measure:  g/dL
Number Analyzed 80 participants
4.0
(3.6 to 4.2)
Aspartate aminotransferase  
Median (Inter-Quartile Range)
Unit of measure:  U/L
Number Analyzed 80 participants
43
(31 to 65)
Alanine aminotransferase  
Median (Inter-Quartile Range)
Unit of measure:  U/L
Number Analyzed 80 participants
34
(24 to 56)
Gamma-glutamyl transpeptidase  
Median (Inter-Quartile Range)
Unit of measure:  U/L
Number Analyzed 80 participants
35
(19 to 71)
alpha-fetoprotein  
Median (Inter-Quartile Range)
Unit of measure:  ng/mL
Number Analyzed 80 participants
4.3
(3.0 to 12.0)
Cirrhosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants
31
  38.8%
HCV RNA level  
Median (Inter-Quartile Range)
Unit of measure:  logIU/mL
Number Analyzed 80 participants
6.2
(5.9 to 6.6)
Treatment Naive  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants
69
  86.3%
HCV NS5A RAS   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants
16
  20.0%
[1]
Measure Description: We identified the following as amino-acid resistance-associated substitutions (RAS) to non-structual 5A (NS5A) inhibitor by direct sequencing: NS5A gene amino acid positions 30, 31, and 93 for patients infected with HCV were examined at baseline.
1.Primary Outcome
Title Change of Serum Endostatin Level (ng/mL) From Baseline to 3 Months
Hide Description We evaluated the serum endostatin at baseline and 3 months after the treatment initiation.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Grazoprevir Plus Elbasvir
Hide Arm/Group Description:

Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.

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.

Overall Number of Participants Analyzed 80
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline 156  (58)
3 months 176  (65)
2.Primary Outcome
Title Change of eGFR Level (mL/Min/1.73m^2) From Baseline to 3 Months
Hide Description We evaluated eGFR level at baseline and 3 months after the treatment initiation.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Grazoprevir Plus Elbasvir
Hide Arm/Group Description:

Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.

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.

Overall Number of Participants Analyzed 80
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73m^2
Baseline 52  (8)
3 months 53  (9)
3.Secondary Outcome
Title Sustained Virological Response-12 (SVR12)
Hide Description SVR12 was defined as undetectable HCV RNA at week 12 after the end of treatment.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Three patients discontinued treatment due to adverse effects.
Arm/Group Title Intention-to-treat Populations Per-protocol Populations
Hide Arm/Group Description:

Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.

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.

Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.

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.

Overall Number of Participants Analyzed 80 77
Measure Type: Count of Participants
Unit of Measure: Participants
76
  95.0%
76
  98.7%
4.Secondary Outcome
Title Change of Serum Alanine Aminotransferase (ALT) Level (U/L) From Baseline to 3 Months
Hide Description We evaluated the serum ALT levels at baseline and 3 months after the treatment initiation.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Grazoprevir Plus Elbasvir
Hide Arm/Group Description:

Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.

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.

Overall Number of Participants Analyzed 80
Mean (Standard Deviation)
Unit of Measure: U/L
Baseline 47  (41)
3 months 21  (29)
5.Secondary Outcome
Title Change of Serum Alpha-fetoprotein Level (ng/mL) From Baseline to 3 Months
Hide Description We evaluated the serum alpha-fetoprotein levels at baseline and 3 months after the treatment initiation.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Grazoprevir Plus Elbasvir
Hide Arm/Group Description:

Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.

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.

Overall Number of Participants Analyzed 80
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline 10.7  (17)
3 months 4.6  (3.7)
6.Secondary Outcome
Title Count of Participants With NS3/4A or NS5A Muttations Who Achieved SVR12
Hide Description We identified the NS3/4A or NS5A muttations by direct sequencing at baseline. Among participants who had mutations, we calcualted the rate of SVR12.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Grazoprevir Plus Elbasvir
Hide Arm/Group Description:

Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.

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.

Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
15
  93.8%
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Grazoprevir Plus Elbasvir
Hide Arm/Group Description

Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.

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.

All-Cause Mortality
Grazoprevir Plus Elbasvir
Affected / at Risk (%)
Total   0/80 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Grazoprevir Plus Elbasvir
Affected / at Risk (%)
Total   3/80 (3.75%) 
Hepatobiliary disorders   
Serious ALT elevation * [1]  3/80 (3.75%) 
*
Indicates events were collected by non-systematic assessment
[1]
ALT>300 U/L during treatment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Grazoprevir Plus Elbasvir
Affected / at Risk (%)
Total   0/80 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Eiichi Ogawa / Assistant Professor
Organization: Kyushu University Hospital
Phone: 81926425909
EMail: eogawa@gim.med.kyushu-u.ac.jp
Layout table for additonal information
Responsible Party: Norihiro Furusyo, Kyushu University
ClinicalTrials.gov Identifier: NCT03144635     History of Changes
Other Study ID Numbers: KULDS-001
First Submitted: April 28, 2017
First Posted: May 9, 2017
Results First Submitted: September 21, 2018
Results First Posted: June 3, 2019
Last Update Posted: June 3, 2019