Trial Outcomes & Findings for A Multiple-Dose Study of Bulevirtide in Participants With Normal and Impaired Renal Function (NCT NCT05760300)
NCT ID: NCT05760300
Last Updated: 2025-09-18
Results Overview
AUCtau is defined as the area under the concentration versus time curve over the dosing interval at steady state at Day 6.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
41 participants
Primary outcome timeframe
Day 6: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, and 24 hours postdose
Results posted on
2025-09-18
Participant Flow
Participants were enrolled at study sites in the United States.
98 participants were screened. The optional Groups C and D were not initiated and no participants were enrolled in these groups.
Participant milestones
| Measure |
Group A: BLV 2 mg (Severe RI Group)
Participants with severe renal impairment (RI) \[estimated glomerular filtration rate (eGFR) ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received bulevirtide (BLV) 2 mg, administered subcutaneously (SC), once daily (QD), for 6 days.
|
Group A: BLV 2 mg (Matched Control)
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Severe RI Group)
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Matched Control)
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
11
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group A: BLV 2 mg (Severe RI Group)
Participants with severe renal impairment (RI) \[estimated glomerular filtration rate (eGFR) ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received bulevirtide (BLV) 2 mg, administered subcutaneously (SC), once daily (QD), for 6 days.
|
Group A: BLV 2 mg (Matched Control)
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Severe RI Group)
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Matched Control)
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
|
Overall Study
Participant Decision
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Multiple-Dose Study of Bulevirtide in Participants With Normal and Impaired Renal Function
Baseline characteristics by cohort
| Measure |
Group A: BLV 2 mg (Severe RI Group)
n=10 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group A: BLV 2 mg (Matched Control)
n=10 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Severe RI Group)
n=11 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Matched Control)
n=10 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
55 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
63 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
57 years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
59 years
STANDARD_DEVIATION 11.9 • n=21 Participants
|
|
Age, Customized
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Age, Customized
>=65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 6: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, and 24 hours postdosePopulation: The plasma PK Analysis Set included all enrolled participants who received at least 1 dose of BLV and had at least 1 measurable plasma PK concentration data reported by PK laboratory for the respective analyte. Participants in the PK Analysis Set with available data were analyzed.
AUCtau is defined as the area under the concentration versus time curve over the dosing interval at steady state at Day 6.
Outcome measures
| Measure |
Group A: BLV 2 mg (Severe RI Group)
n=6 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group A: BLV 2 mg (Matched Control)
n=6 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Severe RI Group)
n=10 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Matched Control)
n=10 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter for Bulevirtide (BLV): AUCtau
|
94.6 hours(h)*nanograms per milliliter(ng/mL)
Standard Deviation 29.8
|
112 hours(h)*nanograms per milliliter(ng/mL)
Standard Deviation 32.6
|
1880 hours(h)*nanograms per milliliter(ng/mL)
Standard Deviation 642
|
1810 hours(h)*nanograms per milliliter(ng/mL)
Standard Deviation 560
|
PRIMARY outcome
Timeframe: Day 6: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, and 24 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed
Cmax is defined as the maximum observed concentration of drug at steady state at Day 6.
Outcome measures
| Measure |
Group A: BLV 2 mg (Severe RI Group)
n=9 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group A: BLV 2 mg (Matched Control)
n=10 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Severe RI Group)
n=10 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Matched Control)
n=10 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
|---|---|---|---|---|
|
PK Parameter for BLV: Cmax ss
|
15.0 ng/mL
Standard Deviation 8.11
|
14.6 ng/mL
Standard Deviation 9.35
|
311 ng/mL
Standard Deviation 110
|
307 ng/mL
Standard Deviation 156
|
SECONDARY outcome
Timeframe: Day 1: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, and 24 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
AUC0-24 is defined as the concentration of drug over time between time 0 hour and time 24 hours.
Outcome measures
| Measure |
Group A: BLV 2 mg (Severe RI Group)
n=9 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group A: BLV 2 mg (Matched Control)
n=9 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Severe RI Group)
n=10 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Matched Control)
n=8 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
|---|---|---|---|---|
|
PK Parameter for BLV: AUC0-24
|
46.5 h*ng/mL
Standard Deviation 13.3
|
53.4 h*ng/mL
Standard Deviation 6.77
|
843 h*ng/mL
Standard Deviation 480
|
876 h*ng/mL
Standard Deviation 458
|
SECONDARY outcome
Timeframe: Day 1: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, and 24 hours postdosePopulation: Participants in the PK Analysis Set were analyzed.
Cmax is defined as the maximum observed concentration of drug.
Outcome measures
| Measure |
Group A: BLV 2 mg (Severe RI Group)
n=10 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group A: BLV 2 mg (Matched Control)
n=10 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Severe RI Group)
n=11 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Matched Control)
n=10 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
|---|---|---|---|---|
|
PK Parameter for BLV: Cmax
|
12.3 ng/mL
Standard Deviation 4.91
|
13.1 ng/mL
Standard Deviation 6.49
|
121 ng/mL
Standard Deviation 86.2
|
146 ng/mL
Standard Deviation 83.9
|
SECONDARY outcome
Timeframe: Day 1: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, and 24 hours postdose; Day 6: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, and 48 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Tmax is defined as the time (observed time point) of Cmax.
Outcome measures
| Measure |
Group A: BLV 2 mg (Severe RI Group)
n=10 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group A: BLV 2 mg (Matched Control)
n=10 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Severe RI Group)
n=11 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Matched Control)
n=10 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
|---|---|---|---|---|
|
PK Parameter for BLV: Tmax
Tmax (Day 1)
|
1.00 h
Interval 1.0 to 2.0
|
1.00 h
Interval 0.5 to 2.0
|
4.00 h
Interval 1.5 to 6.0
|
4.00 h
Interval 1.5 to 9.0
|
|
PK Parameter for BLV: Tmax
Tmax (Day 6)
|
1.00 h
Interval 1.0 to 3.0
|
1.50 h
Interval 1.0 to 6.0
|
3.00 h
Interval 2.0 to 4.03
|
3.00 h
Interval 3.0 to 6.0
|
SECONDARY outcome
Timeframe: Day 1: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, and 24 hours postdose; Day 6: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, and 48 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
t1/2 is defined as the estimate of the terminal elimination half-life of the drug.
Outcome measures
| Measure |
Group A: BLV 2 mg (Severe RI Group)
n=10 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group A: BLV 2 mg (Matched Control)
n=10 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Severe RI Group)
n=11 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Matched Control)
n=10 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
|---|---|---|---|---|
|
PK Parameter for BLV: t1/2
t1/2 (Day 1)
|
2.47 h
Interval 1.32 to 4.34
|
3.95 h
Interval 1.2 to 6.66
|
2.86 h
Interval 1.44 to 14.5
|
3.03 h
Interval 1.53 to 8.23
|
|
PK Parameter for BLV: t1/2
t1/2 (Day 6)
|
3.98 h
Interval 2.84 to 8.72
|
4.60 h
Interval 2.31 to 7.87
|
2.79 h
Interval 1.46 to 7.47
|
2.75 h
Interval 1.44 to 3.78
|
SECONDARY outcome
Timeframe: Day 6: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, and 48 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
CLss/F is defined as the apparent clearance at steady state at Day 6. CLss/F = Dose/AUCtau, where "Dose" is the dose of the drug per interval.
Outcome measures
| Measure |
Group A: BLV 2 mg (Severe RI Group)
n=9 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group A: BLV 2 mg (Matched Control)
n=7 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Severe RI Group)
n=10 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Matched Control)
n=10 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
|---|---|---|---|---|
|
PK Parameter for BLV: CLss/F
|
29.9 milliliters per hour (mL/h)
Standard Deviation 13.4
|
19.1 milliliters per hour (mL/h)
Standard Deviation 7.54
|
5.80 milliliters per hour (mL/h)
Standard Deviation 1.69
|
6.09 milliliters per hour (mL/h)
Standard Deviation 2.22
|
SECONDARY outcome
Timeframe: Day 6: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, and 48 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Vss/F is defined as the apparent volume of distribution at steady state at Day 6.
Outcome measures
| Measure |
Group A: BLV 2 mg (Severe RI Group)
n=9 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group A: BLV 2 mg (Matched Control)
n=7 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Severe RI Group)
n=10 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Matched Control)
n=10 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
|---|---|---|---|---|
|
PK Parameter for BLV: Vss/F
|
222 mL
Standard Deviation 175
|
121 mL
Standard Deviation 69.4
|
24.4 mL
Standard Deviation 10.7
|
25.0 mL
Standard Deviation 14.2
|
SECONDARY outcome
Timeframe: Day 1: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, and 24 hours postdose; Day 6: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, and 48 hours postdosePopulation: The plasma PD Biomarker Analysis Set included all enrolled participants who received at least 1 dose of study drug BLV and had at least 1 measurable plasma PD concentration value reported for each respective analyte. Participants in the PD Biomarker Analysis Set with available data were analyzed.
The PD effect of BLV was evaluated on plasma BA in participants with RI compared to matched control participants with normal renal function. Cmax is defined as the maximum observed concentration of total BA. The plasma bile acid panel includes 15 individual bile acids, and total BA is the sum of these 15 components.
Outcome measures
| Measure |
Group A: BLV 2 mg (Severe RI Group)
n=10 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group A: BLV 2 mg (Matched Control)
n=10 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Severe RI Group)
n=11 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Matched Control)
n=10 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
|---|---|---|---|---|
|
Pharmacodynamic (PD) Parameter for Total Bile Acids (BA): Cmax
Cmax (Day 1)
|
13.5 micromoles per liter (µmol/L)
Standard Deviation 8.58
|
8.54 micromoles per liter (µmol/L)
Standard Deviation 7.02
|
110 micromoles per liter (µmol/L)
Standard Deviation 50.6
|
121 micromoles per liter (µmol/L)
Standard Deviation 53.6
|
|
Pharmacodynamic (PD) Parameter for Total Bile Acids (BA): Cmax
Cmax (Day 6)
|
48.1 micromoles per liter (µmol/L)
Standard Deviation 35.4
|
58.2 micromoles per liter (µmol/L)
Standard Deviation 24.5
|
168 micromoles per liter (µmol/L)
Standard Deviation 83.4
|
207 micromoles per liter (µmol/L)
Standard Deviation 52.1
|
SECONDARY outcome
Timeframe: Days 1 and 6: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, and 24 hours postdosePopulation: Participants in the PD Biomarker Analysis Set with available data were analyzed.
The PD effect of BLV was evaluated on plasma BA in participants with RI compared to matched control participants with normal renal function. AUC0-24 is defined as the concentration of total BA over time between time 0 hour and time 24 hours. The plasma bile acid panel includes 15 individual bile acids, and total BA is the sum of these 15 components.
Outcome measures
| Measure |
Group A: BLV 2 mg (Severe RI Group)
n=10 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group A: BLV 2 mg (Matched Control)
n=10 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Severe RI Group)
n=11 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Matched Control)
n=10 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
|---|---|---|---|---|
|
PD Parameter for Total BA: AUC0-24
AUC0-24 (Day 1)
|
166 h*µmol/L
Standard Deviation 109
|
108 h*µmol/L
Standard Deviation 58.8
|
1290 h*µmol/L
Standard Deviation 613
|
1450 h*µmol/L
Standard Deviation 573
|
|
PD Parameter for Total BA: AUC0-24
AUC0-24 (Day 6)
|
581 h*µmol/L
Standard Deviation 442
|
705 h*µmol/L
Standard Deviation 324
|
2120 h*µmol/L
Standard Deviation 1050
|
2710 h*µmol/L
Standard Deviation 669
|
SECONDARY outcome
Timeframe: Day 1: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, and 24 hours postdose; Day 6: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, and 48 hours postdosePopulation: Participants in the PD Biomarker Analysis Set with available data were analyzed.
The PD effect of BLV was evaluated on plasma BA in participants with RI compared to matched control participants with normal renal function. NetAUC is defined as positive portion of area under the baseline-adjusted biomarker concentration versus time curve over the dosing interval. The plasma bile acid panel includes 15 individual bile acids, and total BA is the sum of these 15 components.
Outcome measures
| Measure |
Group A: BLV 2 mg (Severe RI Group)
n=10 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group A: BLV 2 mg (Matched Control)
n=10 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Severe RI Group)
n=11 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Matched Control)
n=10 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
|---|---|---|---|---|
|
PD Parameter for Total BA: NetAUC
NetAUC (Day 1)
|
54.9 h*µmol/L
Standard Deviation 40.4
|
66.1 h*µmol/L
Standard Deviation 57.6
|
1240 h*µmol/L
Standard Deviation 598
|
1400 h*µmol/L
Standard Deviation 572
|
|
PD Parameter for Total BA: NetAUC
NetAUC (Day 6)
|
496 h*µmol/L
Standard Deviation 433
|
662 h*µmol/L
Standard Deviation 330
|
2060 h*µmol/L
Standard Deviation 1020
|
2660 h*µmol/L
Standard Deviation 666
|
SECONDARY outcome
Timeframe: Up to 36 daysPopulation: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug BLV.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or if the AE onset date was the same as the date of study drug start date then the AE onset time must have been on or after the study drug start time. If the AE onset time was missing when the start dates was the same, the AE was considered treatment emergent.and/or any AEs leading to premature discontinuation of study drug.
Outcome measures
| Measure |
Group A: BLV 2 mg (Severe RI Group)
n=10 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group A: BLV 2 mg (Matched Control)
n=10 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Severe RI Group)
n=11 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Matched Control)
n=10 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
|---|---|---|---|---|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
40.0 percentage of participants
|
20.0 percentage of participants
|
27.3 percentage of participants
|
30.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 36 daysPopulation: Participants in the Safety Analysis Set were analyzed.
A treatment-emergent laboratory abnormality was any value that was outside the reference range at any time post baseline up to and including the date of last study drug dose plus 30 days. Grading categories are determined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening; Grade 5: Death. Participants with at least a 1 grade increased from baseline for an individual laboratory test where the maximum post baseline laboratory abnormality was grade 1 or higher and grade 3 or higher were reported. The maximum post baseline toxicity grade across all tests for an individual participant was used in analysis.
Outcome measures
| Measure |
Group A: BLV 2 mg (Severe RI Group)
n=10 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group A: BLV 2 mg (Matched Control)
n=10 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Severe RI Group)
n=11 Participants
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Matched Control)
n=10 Participants
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
|---|---|---|---|---|
|
Percentage of Participants Experiencing Laboratory Abnormalities
Grade 1 or Higher
|
100 percentage of participants
|
90.0 percentage of participants
|
100 percentage of participants
|
90.0 percentage of participants
|
|
Percentage of Participants Experiencing Laboratory Abnormalities
Grade 3 or Higher
|
50.0 percentage of participants
|
0 percentage of participants
|
45.5 percentage of participants
|
0 percentage of participants
|
Adverse Events
Group A: BLV 2 mg (Severe RI Group)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group A: BLV 2 mg (Matched Control)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group B: BLV 10 mg (Severe RI Group)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Group B: BLV 10 mg (Matched Control)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A: BLV 2 mg (Severe RI Group)
n=10 participants at risk
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group A: BLV 2 mg (Matched Control)
n=10 participants at risk
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Severe RI Group)
n=11 participants at risk
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Matched Control)
n=10 participants at risk
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
9.1%
1/11 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
Other adverse events
| Measure |
Group A: BLV 2 mg (Severe RI Group)
n=10 participants at risk
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group A: BLV 2 mg (Matched Control)
n=10 participants at risk
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 2 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Severe RI Group)
n=11 participants at risk
Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
Group B: BLV 10 mg (Matched Control)
n=10 participants at risk
Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] received BLV 10 mg, administered SC, QD, for 6 days.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Eosinophilia
|
10.0%
1/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/11 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.0%
1/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/11 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
9.1%
1/11 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
|
General disorders
Vessel puncture site haemorrhage
|
10.0%
1/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/11 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/11 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/11 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
10.0%
1/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
|
Investigations
Lipase increased
|
10.0%
1/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/11 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
10.0%
1/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/11 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
10.0%
1/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
10.0%
1/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/11 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
9.1%
1/11 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
10.0%
1/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
9.1%
1/11 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
10.0%
1/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/11 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
10.0%
1/10 • All-Cause Mortality: Up to 420 days; Adverse Events: Up to 36 days
All-Cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification (ID) number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER