Trial Outcomes & Findings for A Study for G1b CHC Patients With CKD-3 Treated With Grazoprevir Plus Elbasvir (NCT NCT03144635)
NCT ID: NCT03144635
Last Updated: 2019-06-03
Results Overview
We evaluated the serum endostatin at baseline and 3 months after the treatment initiation.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
80 participants
Primary outcome timeframe
3 months
Results posted on
2019-06-03
Participant Flow
Participant milestones
| Measure |
Grazoprevir Plus Elbasvir
Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.
Grazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.
|
|---|---|
|
Overall Study
STARTED
|
80
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
80
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study for G1b CHC Patients With CKD-3 Treated With Grazoprevir Plus Elbasvir
Baseline characteristics by cohort
| Measure |
Grazoprevir Plus Elbasvir
n=80 Participants
Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.
Grazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.
|
|---|---|
|
Age, Continuous
|
77 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
80 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Japan
|
80 Participants
n=99 Participants
|
|
Body mass index
|
23.3 kg/m^2
n=99 Participants
|
|
Albumin
|
4.0 g/dL
n=99 Participants
|
|
Aspartate aminotransferase
|
43 U/L
n=99 Participants
|
|
Alanine aminotransferase
|
34 U/L
n=99 Participants
|
|
Gamma-glutamyl transpeptidase
|
35 U/L
n=99 Participants
|
|
alpha-fetoprotein
|
4.3 ng/mL
n=99 Participants
|
|
Cirrhosis
|
31 Participants
n=99 Participants
|
|
HCV RNA level
|
6.2 logIU/mL
n=99 Participants
|
|
Treatment Naive
|
69 Participants
n=99 Participants
|
|
HCV NS5A RAS
|
16 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 monthsWe evaluated the serum endostatin at baseline and 3 months after the treatment initiation.
Outcome measures
| Measure |
Grazoprevir Plus Elbasvir
n=80 Participants
Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.
Grazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.
|
Per-protocol Populations
Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.
Grazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.
|
|---|---|---|
|
Change of Serum Endostatin Level (ng/mL) From Baseline to 3 Months
Baseline
|
156 ng/mL
Standard Deviation 58
|
—
|
|
Change of Serum Endostatin Level (ng/mL) From Baseline to 3 Months
3 months
|
176 ng/mL
Standard Deviation 65
|
—
|
PRIMARY outcome
Timeframe: 3 monthsWe evaluated eGFR level at baseline and 3 months after the treatment initiation.
Outcome measures
| Measure |
Grazoprevir Plus Elbasvir
n=80 Participants
Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.
Grazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.
|
Per-protocol Populations
Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.
Grazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.
|
|---|---|---|
|
Change of eGFR Level (mL/Min/1.73m^2) From Baseline to 3 Months
Baseline
|
52 mL/min/1.73m^2
Standard Deviation 8
|
—
|
|
Change of eGFR Level (mL/Min/1.73m^2) From Baseline to 3 Months
3 months
|
53 mL/min/1.73m^2
Standard Deviation 9
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Three patients discontinued treatment due to adverse effects.
SVR12 was defined as undetectable HCV RNA at week 12 after the end of treatment.
Outcome measures
| Measure |
Grazoprevir Plus Elbasvir
n=80 Participants
Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.
Grazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.
|
Per-protocol Populations
n=77 Participants
Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.
Grazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.
|
|---|---|---|
|
Sustained Virological Response-12 (SVR12)
|
76 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: 3 monthsWe evaluated the serum ALT levels at baseline and 3 months after the treatment initiation.
Outcome measures
| Measure |
Grazoprevir Plus Elbasvir
n=80 Participants
Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.
Grazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.
|
Per-protocol Populations
Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.
Grazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.
|
|---|---|---|
|
Change of Serum Alanine Aminotransferase (ALT) Level (U/L) From Baseline to 3 Months
Baseline
|
47 U/L
Standard Deviation 41
|
—
|
|
Change of Serum Alanine Aminotransferase (ALT) Level (U/L) From Baseline to 3 Months
3 months
|
21 U/L
Standard Deviation 29
|
—
|
SECONDARY outcome
Timeframe: 3 monthsWe evaluated the serum alpha-fetoprotein levels at baseline and 3 months after the treatment initiation.
Outcome measures
| Measure |
Grazoprevir Plus Elbasvir
n=80 Participants
Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.
Grazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.
|
Per-protocol Populations
Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.
Grazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.
|
|---|---|---|
|
Change of Serum Alpha-fetoprotein Level (ng/mL) From Baseline to 3 Months
Baseline
|
10.7 ng/mL
Standard Deviation 17
|
—
|
|
Change of Serum Alpha-fetoprotein Level (ng/mL) From Baseline to 3 Months
3 months
|
4.6 ng/mL
Standard Deviation 3.7
|
—
|
SECONDARY outcome
Timeframe: 3 monthsWe identified the NS3/4A or NS5A muttations by direct sequencing at baseline. Among participants who had mutations, we calcualted the rate of SVR12.
Outcome measures
| Measure |
Grazoprevir Plus Elbasvir
n=16 Participants
Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.
Grazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.
|
Per-protocol Populations
Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.
Grazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.
|
|---|---|---|
|
Count of Participants With NS3/4A or NS5A Muttations Who Achieved SVR12
|
15 Participants
|
—
|
Adverse Events
Grazoprevir Plus Elbasvir
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Grazoprevir Plus Elbasvir
n=80 participants at risk
Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.
Grazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.
|
|---|---|
|
Hepatobiliary disorders
Serious ALT elevation
|
3.8%
3/80 • 3 months
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Eiichi Ogawa / Assistant Professor
Kyushu University Hospital
Phone: 81926425909
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place