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

NCT03144635 | Completed Phase 4 Results DMC

• 1 other identifier: KULDS-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C Viral; Chronic Kidney Disease stage3

Keywords

Direct Acting Antivirals; Grazoprevir; Elbasvir

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  3 months

Secondary Outcomes (4)

• Sustained Virological Response-12 (SVR12)

  3 months

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

  3 months

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

  3 months

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

  3 months

Study Arms (1)

Grazoprevir plus Elbasvir

EXPERIMENTAL

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

Drug: Grazoprevir plus Elbasvir

Interventions

Grazoprevir plus Elbasvir DRUG

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 plus Elbasvir

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyushu University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Related Publications (3)

• 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.

  PMID: 23542346 BACKGROUND

• 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.

  PMID: 27142311 BACKGROUND

• 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.

  PMID: 26095167 BACKGROUND

MeSH Terms

Conditions

Hepatitis C

Interventions

grazoprevir; elbasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr. Eiichi Ogawa / Assistant Professor
• Organization: Kyushu University Hospital

eogawa@gim.med.kyushu-u.ac.jp

81926425909

Study Officials

• Norihiro Furusyo, MD, PhD

  Kyushu University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of General Internal Medicine

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 9, 2017
• Study Start: April 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: September 20, 2018
• Last Updated: June 3, 2019
• Results First Posted: June 3, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)