CClinicalTrials.gg
Sign In
CompletedNCT03144635Updated Jun 3, 2019Results posted

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

A Phase 4 interventional study of Grazoprevir plus Elbasvir in Hepatitis C Viral and Chronic Kidney Disease stage3, sponsored by Kyushu University. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-06-03.

Sponsored by Kyushu University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hepatitis C Viral
  • Chronic Kidney Disease stage3

Keywords

  • Direct Acting Antivirals
  • Grazoprevir
  • Elbasvir
03

In context

Hepatitis C

2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.

This study's enrollment of 80 is close to the median of 79 across 1,633 interventional studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

Kyushu University is the lead sponsor of 13 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Grazoprevir plus Elbasvir

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

    Drug: Grazoprevir plus Elbasvir

Interventions

  • DrugGrazoprevir 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

  2. 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.

    Time frame: 3 months

Secondary outcomes

  1. Sustained Virological Response-12 (SVR12)

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

    Time frame: 3 months

  2. 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.

    Time frame: 3 months

  3. 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.

    Time frame: 3 months

  4. 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.

    Time frame: 3 months

07

Results

Posted Jun 3, 2019

Participant flow

Participant flow — Overall Study
MilestoneGrazoprevir Plus Elbasvir
Started80
Completed0
Not completed80

Outcome measures

PrimaryChange 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.

Time frame:
3 months
Reported as:
Mean · ng/mL
Change of Serum Endostatin Level (ng/mL) From Baseline to 3 Months
ng/mLGrazoprevir Plus Elbasvir
Baseline156 ± 58
3 months176 ± 65
PrimaryChange 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.

Time frame:
3 months
Reported as:
Mean · mL/min/1.73m^2
Change of eGFR Level (mL/Min/1.73m^2) From Baseline to 3 Months
mL/min/1.73m^2Grazoprevir Plus Elbasvir
Baseline52 ± 8
3 months53 ± 9
SecondarySustained Virological Response-12 (SVR12)

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

Time frame:
3 months
Reported as:
Count of participants · Participants
Sustained Virological Response-12 (SVR12)
ParticipantsIntention-to-treat PopulationsPer-protocol Populations
Sustained Virological Response-12 (SVR12)7676
SecondaryChange 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.

Time frame:
3 months
Reported as:
Mean · U/L
Change of Serum Alanine Aminotransferase (ALT) Level (U/L) From Baseline to 3 Months
U/LGrazoprevir Plus Elbasvir
Baseline47 ± 41
3 months21 ± 29
SecondaryChange 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.

Time frame:
3 months
Reported as:
Mean · ng/mL
Change of Serum Alpha-fetoprotein Level (ng/mL) From Baseline to 3 Months
ng/mLGrazoprevir Plus Elbasvir
Baseline10.7 ± 17
3 months4.6 ± 3.7
SecondaryCount 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.

Time frame:
3 months
Reported as:
Count of participants · Participants
Count of Participants With NS3/4A or NS5A Muttations Who Achieved SVR12
ParticipantsGrazoprevir Plus Elbasvir
Count of Participants With NS3/4A or NS5A Muttations Who Achieved SVR1215

Adverse events

Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Grazoprevir Plus Elbasvir0/80 (0%)3/80 (3.8%)0/80 (0%)
Most frequent serious events
Most frequent serious events
EventGrazoprevir Plus Elbasvir
Serious ALT elevationHepatobiliary disorders3/80

Baseline characteristics

Age, Continuous
Age, Continuous(years)Grazoprevir Plus Elbasvir
Median77 (69 to 80)
Sex: Female, Male
Sex: Female, Male(Participants)Grazoprevir Plus Elbasvir
Female48
Male32
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Grazoprevir Plus Elbasvir
American Indian or Alaska Native0
Asian80
Native Hawaiian or Other Pacific Islander0
Black or African American0
White0
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)Grazoprevir Plus Elbasvir
Japan80
Body mass index
Body mass index(kg/m^2)Grazoprevir Plus Elbasvir
Median23.3 (20.7 to 25.2)
Albumin
Albumin(g/dL)Grazoprevir Plus Elbasvir
Median4.0 (3.6 to 4.2)
Aspartate aminotransferase
Aspartate aminotransferase(U/L)Grazoprevir Plus Elbasvir
Median43 (31 to 65)
Alanine aminotransferase
Alanine aminotransferase(U/L)Grazoprevir Plus Elbasvir
Median34 (24 to 56)

6 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Kyushu University Hospital
    Fukuoka, 812-8582, Japan
09

References and documents

Publications

  • 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. PubMed 23542346 ↗
  • 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. PubMed 27142311 ↗
  • 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. PubMed 26095167 ↗

Study documents

  • Protocol and statistical analysis plan · Sep 20, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03144635
Lead sponsor
Kyushu University
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Norihiro Furusyo (Associate Professor, Department of General Internal Medicine, Kyushu University) — Principal investigator
First posted
May 9, 2017
Start date
Apr 1, 2017
Primary completion
Dec 31, 2017
Completion
Sep 20, 2018
Results posted
Jun 3, 2019
Last update
Jun 3, 2019

Study contacts

Norihiro Furusyo, MD, PhD
principal investigator · Kyushu University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hepatitis C→

Other studies from this sponsor

Kyushu University

Start the discussion