Trial Outcomes & Findings for EBR/GZR for HCV-1b Patients Receiving Hemodialysis (NCT NCT03420300)
NCT ID: NCT03420300
Last Updated: 2020-03-11
Results Overview
Proportion of patients who had undetectable serum HCV RNA 12 weeks after the completion of elbasvir/grazoprevir (EBR/GZR)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
24 weeks
Results posted on
2020-03-11
Participant Flow
The study was conducted at 6 medical center in Taiwan to evaluate the tolerability and efficacy of elbasvir/grazoprevir (EBR/GZR) for patients with hepatitis C virus genotype 1 infection and receiving hemodialysis. The recruitment period was from 05 June, 2018 to 30 April, 2019
The study was an one-arm, open label, multi-center study. Patients were checked for inclusion and exclusion criteria to assess the eligibility. There was no pre-assignment criteria in the study.
Participant milestones
| Measure |
EBR/GZR
Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination \[FDC\]): 1 table per os per day for 12 weeks
EBR/GZR: Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination \[FDC\]): 1 table per os per day for 12 weeks
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
EBR/GZR
Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination \[FDC\]): 1 table per os per day for 12 weeks
EBR/GZR: Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination \[FDC\]): 1 table per os per day for 12 weeks
|
|---|---|
|
Overall Study
Death
|
2
|
Baseline Characteristics
EBR/GZR for HCV-1b Patients Receiving Hemodialysis
Baseline characteristics by cohort
| Measure |
EBR/GZR
n=40 Participants
Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination \[FDC\]): 1 table per os per day for 12 weeks
EBR/GZR: Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination \[FDC\]): 1 table per os per day for 12 weeks
|
|---|---|
|
Age, Customized
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
40 participants
n=5 Participants
|
|
Treatment-naive
|
35 Participants
n=5 Participants
|
|
History of renal transplantation
|
5 Participants
n=5 Participants
|
|
Diabetes mellitus
|
13 Participants
n=5 Participants
|
|
Hypertension
|
23 Participants
n=5 Participants
|
|
Dyslipidemia
|
8 Participants
n=5 Participants
|
|
Hemoglobin
|
11.8 g/dL
n=5 Participants
|
|
Absolute neutrophil count
|
3.7 10^9 cells/L
n=5 Participants
|
|
Platelet count
|
196 10^9 cells/L
n=5 Participants
|
|
International normalized ratio (INR)
|
1.01 ratio
n=5 Participants
|
|
Albumin
|
4.3 g/dL
n=5 Participants
|
|
Total bilirubin
|
0.5 mg/dL
n=5 Participants
|
|
Alanine aminotransferase
|
28 IU/L
n=5 Participants
|
|
Creatinine
|
7.3 mg/dL
n=5 Participants
|
|
eGFR
|
7 mL/min/1.73m^2
n=5 Participants
|
|
IL28B rs2979860 non-CC genotype
|
6 Participants
n=5 Participants
|
|
HCV RNA
|
5.60 Log10 IU/mL
n=5 Participants
|
|
HCV RNA > 800,000 IU/mL
|
11 Participants
n=5 Participants
|
|
Liver stiffness measurement (LSM)
|
7.1 kPa
n=5 Participants
|
|
Fibrosis stage
F0-1
|
20 Participants
n=5 Participants
|
|
Fibrosis stage
F2
|
14 Participants
n=5 Participants
|
|
Fibrosis stage
F3
|
2 Participants
n=5 Participants
|
|
Fibrosis stage
F4
|
4 Participants
n=5 Participants
|
|
Resistance associate substitution (RAS)
NS3
|
33 Participants
n=5 Participants
|
|
Resistance associate substitution (RAS)
NS5A
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksProportion of patients who had undetectable serum HCV RNA 12 weeks after the completion of elbasvir/grazoprevir (EBR/GZR)
Outcome measures
| Measure |
EBR/GZR
n=40 Participants
Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination \[FDC\]): 1 table per os per day for 12 weeks
EBR/GZR: Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination \[FDC\]): 1 table per os per day for 12 weeks
|
|---|---|
|
Sustained Virologic Response (SVR12) Rate
|
38 Participants
|
SECONDARY outcome
Timeframe: 12 weeksProportion of participants who withdrew from the study due to any adverse events (AEs) which were judged related to elbasvir/grazoprevir (EBR/GZR)
Outcome measures
| Measure |
EBR/GZR
n=40 Participants
Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination \[FDC\]): 1 table per os per day for 12 weeks
EBR/GZR: Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination \[FDC\]): 1 table per os per day for 12 weeks
|
|---|---|
|
Treatment-emergent Adverse Event (AE)-Related Withdrawal Rate
|
0 Participants
|
SECONDARY outcome
Timeframe: 36 weeksProportion of patients who had undetectable serum HCV RNA 24 weeks after the completion of elbasvir/grazoprevir (EBR/GZR)
Outcome measures
| Measure |
EBR/GZR
n=40 Participants
Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination \[FDC\]): 1 table per os per day for 12 weeks
EBR/GZR: Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination \[FDC\]): 1 table per os per day for 12 weeks
|
|---|---|
|
Sustained Virologic Response (SVR24) Rate
|
38 Participants
|
SECONDARY outcome
Timeframe: 4 weeksProportion of patients who had undetectable serum HCV RNA at week 4 of elbasvir/grazoprevir (EBR/GZR) treatment
Outcome measures
| Measure |
EBR/GZR
n=40 Participants
Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination \[FDC\]): 1 table per os per day for 12 weeks
EBR/GZR: Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination \[FDC\]): 1 table per os per day for 12 weeks
|
|---|---|
|
Rapid Virologic Response (RVR) Rate
|
39 Participants
|
SECONDARY outcome
Timeframe: 12 weeksProportion of patients who had undetectable serum HCV RNA at the time point of treatment completion for elbasvir/grazoprevir (EBR/GZR)
Outcome measures
| Measure |
EBR/GZR
n=40 Participants
Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination \[FDC\]): 1 table per os per day for 12 weeks
EBR/GZR: Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination \[FDC\]): 1 table per os per day for 12 weeks
|
|---|---|
|
End-of-treatment Virological Response (EOTVR) Rate
|
40 Participants
|
SECONDARY outcome
Timeframe: 12 weeksProportion of patients who completed 12 weeks of elbasvir/grazoprevir (EBR/GZR) treatment and who had undetectable serum HCV RNA at week 12 of treatment
Outcome measures
| Measure |
EBR/GZR
n=40 Participants
Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination \[FDC\]): 1 table per os per day for 12 weeks
EBR/GZR: Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination \[FDC\]): 1 table per os per day for 12 weeks
|
|---|---|
|
Week 12 Virologic Response (W12VR)
|
39 Participants
|
Adverse Events
EBR/GZR
Serious events: 5 serious events
Other events: 7 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
EBR/GZR
n=40 participants at risk
Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination \[FDC\]): 1 table per os per day for 12 weeks
EBR/GZR: Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination \[FDC\]): 1 table per os per day for 12 weeks
|
|---|---|
|
General disorders
Suicide
|
2.5%
1/40 • Number of events 1 • 6 months
|
|
Cardiac disorders
Acute myocardial infarction
|
2.5%
1/40 • Number of events 1 • 6 months
|
|
Cardiac disorders
Cardiac arrrythmia
|
2.5%
1/40 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Non-variceal gastrointestinal bleeding
|
2.5%
1/40 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Hepatocellular carcinoma
|
2.5%
1/40 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
EBR/GZR
n=40 participants at risk
Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination \[FDC\]): 1 table per os per day for 12 weeks
EBR/GZR: Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination \[FDC\]): 1 table per os per day for 12 weeks
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
7.5%
3/40 • Number of events 3 • 6 months
|
|
General disorders
Fatigue
|
5.0%
2/40 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Anorexia
|
5.0%
2/40 • Number of events 2 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place