Phase 4
Completed N=80
A Study for G1b CHC Patients With CKD-3 Treated With Grazoprevir Plus Elbasvir
Hepatitis C Viral · Chronic Kidney Disease stage3
Source: ClinicalTrials.gov NCT03144635 ↗
Enrolled (actual)
80
Serious AEs
3.8%
Results posted
Jun 2019
Primary outcomePrimary: Change of Serum Endostatin Level (ng/mL) From Baseline to 3 Months — 156; 176 ng/mL
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Serum Endostatin Level (ng/mL) From Baseline to 3 Months |
156; 176 | — |
| PRIMARY Change of eGFR Level (mL/Min/1.73m^2) From Baseline to 3 Months |
52; 53 | — |
| SECONDARY Sustained Virological Response-12 (SVR12) |
76; 76 | — |
| SECONDARY Change of Serum Alanine Aminotransferase (ALT) Level (U/L) From Baseline to 3 Months |
47; 21 | — |
| SECONDARY Change of Serum Alpha-fetoprotein Level (ng/mL) From Baseline to 3 Months |
10.7; 4.6 | — |
| SECONDARY Count of Participants With NS3/4A or NS5A Muttations Who Achieved SVR12 |
15 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03144635). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.