Hepatitis C ViralPhase 4NCT03144635

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

A Phase 4 study testing Grazoprevir plus Elbasvir in people with Hepatitis C Viral and Chronic Kidney Disease stage3, run by Kyushu University at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 years and older
Conditions the study is for: Hepatitis C Viral, Chronic Kidney Disease stage3
What is being tested?: Grazoprevir plus Elbasvir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteJapan
Study dates: 1 Apr 2017to 20 Sep 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 9Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Kyushu University Hospital
Fukuoka, 812-8582

Other trials in Japan

About this study

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

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.

Conditions: Hepatitis C Viral, Chronic Kidney Disease stage3
Being tested: Grazoprevir plus Elbasvir
Keywords: Direct Acting Antivirals, Grazoprevir, Elbasvir
Medical subject headings: Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Grazoprevir plus ElbasvirDrug
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 groups in NCT03144635
Study group	Role	What they receive
Grazoprevir plus Elbasvir	Experimental	Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks. Receives: Drug: Grazoprevir plus Elbasvir

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 months
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.
Measured: 3 months

Secondary outcomes (4)

Sustained Virological Response-12 (SVR12)
SVR12 was defined as undetectable HCV RNA at week 12 after the end of treatment.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201720 Sep 2018

First posted9 May 2017
Study start1 Apr 2017
Primary completion31 Dec 2017
Study completion20 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Hepatitis C ViralStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03144635
Sponsor's protocol ID: KULDS-001
Status last verified: Feb 2019
First submitted: 28 Apr 2017
Last updated: 3 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Not yet recruitingPhase 4
Combating Related Epidemics in HCV
HIV - Human Immunodeficiency Virus, Hepatitis B Virus (HBV)

All Hepatitis C Viral trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Multicenter Observational Study for Characterization of Renal Function G1b CHC Patients With CKD-3 Treated With Grazoprevir Plus Elbasvir
ClinicalTrials.gov ID: NCT03144635
Acronym / sponsor ID: KULDS-001
Conditions: Hepatitis C Viral, Chronic Kidney Disease stage3
Keywords: Direct Acting Antivirals, Grazoprevir, Elbasvir
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Kyushu UniversityUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: 1 Apr 2017 (actual)
Primary completion: 31 Dec 2017 (actual)
Study completion: 20 Sep 2018 (actual)
First posted: 9 May 2017 (actual)
Results: Posted 3 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Grazoprevir plus Elbasvir	Experimental	Drug: Grazoprevir plus ElbasvirGrazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Grazoprevir plus ElbasvirAn oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.	Drug	Grazoprevir plus Elbasvir

Primary outcome

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.

4 secondary outcomes

Sustained Virological Response-12 (SVR12)
Time frame: 3 months
Change of Serum Alanine Aminotransferase (ALT) Level (U/L) From Baseline to 3 Months
Time frame: 3 months
Change of Serum Alpha-fetoprotein Level (ng/mL) From Baseline to 3 Months
Time frame: 3 months
Count of Participants With NS3/4A or NS5A Muttations Who Achieved SVR12
Time frame: 3 months

Results and safety

Results posted to the registry on 3 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Grazoprevir Plus Elbasvir	80	0

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

Time frame: 3 months. Mean (Standard Deviation). Unit: ng/mL

Measure	Grazoprevir Plus Elbasvir n = 80
Baseline	156 (58)
3 months	176 (65)

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

Time frame: 3 months. Mean (Standard Deviation). Unit: mL/min/1.73m^2

Measure	Grazoprevir Plus Elbasvir n = 80
Baseline	52 (8)
3 months	53 (9)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Grazoprevir Plus Elbasvir	3 of 80 (3.8%)	0 of 80 (0%)	0 of 80

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23542346Furusyo 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.
Background: PubMed 27142311Ogawa 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.
Background: PubMed 26095167Ogawa 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.
Individual participant dataSharing planned: No

Related trials for Hepatitis C Viral

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Not yet recruitingPhase 4
Combating Related Epidemics in HCV
HIV - Human Immunodeficiency Virus, Hepatitis B Virus (HBV)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Norihiro Furusyo, MD, PhD principal investigator

Kyushu University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Grazoprevir plus Elbasvir in people with Hepatitis C Viral and Chronic Kidney Disease stage3, run by Kyushu University at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Serum Endostatin Level (ng/mL) From Baseline to 3 Months (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03144635, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019.