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A Study for G1b CHC Patients With CKD-3 Treated With Grazoprevir Plus Elbasvir

Primary Purpose

Hepatitis C Viral, Chronic Kidney Disease stage3

Status

Completed

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

Grazoprevir plus Elbasvir

About this trial

This is an interventional treatment trial for Hepatitis C Viral focused on measuring Direct Acting Antivirals, Grazoprevir, Elbasvir

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects aged 20 years or older.
Patients positive for HCV RNA for over 6 months and infected with genotype 1b chronic hepatitis C, including compensated cirrhosis.
Patients without co-infection of hepatitis B virus.
Patients without co-infection of human immunodeficiency virus
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:

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

Sites / Locations

Kyushu University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Grazoprevir plus Elbasvir

Arm Description

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

Outcomes

Primary Outcome Measures

Change of Serum Endostatin Level (ng/mL) From Baseline to 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

We evaluated eGFR level at baseline and 3 months after the treatment initiation.

Secondary Outcome Measures

Sustained Virological Response-12 (SVR12)

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

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

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

We identified the NS3/4A or NS5A muttations by direct sequencing at baseline. Among participants who had mutations, we calcualted the rate of SVR12.

Full Information

NCT ID

NCT03144635

First Posted

April 28, 2017

Last Updated

February 18, 2019

Sponsor

Kyushu University

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT03144635

Brief Title

A Study for G1b CHC Patients With CKD-3 Treated With Grazoprevir Plus Elbasvir

Official Title

A Prospective Multicenter Observational Study for Characterization of Renal Function G1b CHC Patients With CKD-3 Treated With Grazoprevir Plus Elbasvir

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

April 1, 2017 (Actual)

Primary Completion Date

December 31, 2017 (Actual)

Study Completion Date

September 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kyushu University

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C Viral, Chronic Kidney Disease stage3

Keywords

Direct Acting Antivirals, Grazoprevir, Elbasvir

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Grazoprevir plus Elbasvir

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Grazoprevir plus Elbasvir

Intervention Description

An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.

Primary Outcome Measure Information:

Title

Change of Serum Endostatin Level (ng/mL) From Baseline to 3 Months

Description

We evaluated the serum endostatin at baseline and 3 months after the treatment initiation.

Time Frame

3 months

Title

Change of eGFR Level (mL/Min/1.73m^2) From Baseline to 3 Months

Description

We evaluated eGFR level at baseline and 3 months after the treatment initiation.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Sustained Virological Response-12 (SVR12)

Description

SVR12 was defined as undetectable HCV RNA at week 12 after the end of treatment.

Time Frame

3 months

Title

Change of Serum Alanine Aminotransferase (ALT) Level (U/L) From Baseline to 3 Months

Description

We evaluated the serum ALT levels at baseline and 3 months after the treatment initiation.

Time Frame

3 months

Title

Change of Serum Alpha-fetoprotein Level (ng/mL) From Baseline to 3 Months

Description

We evaluated the serum alpha-fetoprotein levels at baseline and 3 months after the treatment initiation.

Time Frame

3 months

Title

Count of Participants With NS3/4A or NS5A Muttations Who Achieved SVR12

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects aged 20 years or older. Patients positive for HCV RNA for over 6 months and infected with genotype 1b chronic hepatitis C, including compensated cirrhosis. Patients without co-infection of hepatitis B virus. Patients without co-infection of human immunodeficiency virus 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: Patients with decompensated cirrhosis (Child Pugh B and C) Patients with albumin <3.0 g/dL and platelets <75,000 /μL Patients with autoimmune hepatitis Constant heavy alcohol drinkers (converted to ethanol ≥60 g/day) Patients who have a history of hypersensitivity to grazoprevir and elbasvir Patients who are pregnant females, or females who may become pregnant, or females who are breastfeeding Patients with heart disease that is hard to control (e.g., very recent cardiac infarction, severe heart failure, unstable arrhythmia) Patients who are under medication with drugs listed as contraindication in a package insert of grazoprevir plus elbasvir treatment Patients judged (by the physician in charge of research) to be inappropriate as subjects for the study for any other reasons.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Norihiro Furusyo, MD, PhD

Organizational Affiliation

Kyushu University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kyushu University Hospital

City

Fukuoka

ZIP/Postal Code

812-8582

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23542346

Citation

Furusyo N, Ogawa E, Nakamuta M, Kajiwara E, Nomura H, Dohmen K, Takahashi K, Satoh T, Azuma K, Kawano A, Tanabe Y, Kotoh K, Shimoda S, Hayashi J; Kyushu University Liver Disease Study (KULDS) Group. Telaprevir can be successfully and safely used to treat older patients with genotype 1b chronic hepatitis C. J Hepatol. 2013 Aug;59(2):205-12. doi: 10.1016/j.jhep.2013.03.020. Epub 2013 Mar 28.

Results Reference

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PubMed Identifier

27142311

Citation

Ogawa E, Furusyo N, Yamashita N, Kawano A, Takahashi K, Dohmen K, Nakamuta M, Satoh T, Nomura H, Azuma K, Koyanagi T, Kotoh K, Shimoda S, Kajiwara E, Hayashi J; Kyushu University Liver Disease Study(KULDS) Group. Effectiveness and safety of daclatasvir plus asunaprevir for patients with hepatitis C virus genotype 1b aged 75 years and over with or without cirrhosis. Hepatol Res. 2017 Mar;47(3):E120-E131. doi: 10.1111/hepr.12738. Epub 2016 Jun 10.

Results Reference

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PubMed Identifier

26095167

Citation

Ogawa E, Furusyo N, Kajiwara E, Nomura H, Kawano A, Takahashi K, Dohmen K, Satoh T, Azuma K, Nakamuta M, Koyanagi T, Kotoh K, Shimoda S, Hayashi J. Comparative effectiveness and safety study of triple therapy with simeprevir or telaprevir for non-cirrhotic patients with chronic hepatitis C virus genotype 1b infection. J Gastroenterol Hepatol. 2015 Dec;30(12):1759-67. doi: 10.1111/jgh.13016.

Results Reference

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A Study for G1b CHC Patients With CKD-3 Treated With Grazoprevir Plus Elbasvir

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