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NCT Number: NCT03144635

A Study for 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.

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Key information

Conditions

Hepatitis C Viral Blood-Borne Infections Chronic Kidney Disease stage3 Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Sustained Virological Response-12 (SVR12)

    Time frame: 3 months

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

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

    Time frame: 3 months

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

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

    Time frame: 3 months

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

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

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Kyushu University

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
May 9, 2017
Registry last updated
Jun 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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