Trial Outcomes & Findings for A Proof-of-Mechanism Study to Determine the Effect of Danicopan on C3 Levels in Participants With C3G or IC-MPGN (NCT NCT03124368)
NCT ID: NCT03124368
Last Updated: 2021-11-04
Results Overview
Serum C3 levels were measured by conventional Roche immunoturbidimetric assay method. Change from Baseline = Serum C3 levels on Day 15 - Baseline Serum C3 levels
COMPLETED
PHASE2
6 participants
Baseline, Day 15
2021-11-04
Participant Flow
Participants were recruited from 5 study centers total in Australia, Belgium, and The Netherlands. Only 3 study centers, 1 in each country, treated participants.
Participant milestones
| Measure |
Group 1: Danicopan 100 mg TID (Sentinel)
Participants received 100 milligrams (mg) of danicopan three times daily (TID) during the Treatment Period.
|
Group 2: Danicopan up to 200 mg TID
Participants received not more than 200 mg of danicopan TID during the Treatment Period.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
4
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
2
|
4
|
|
Overall Study
COMPLETED
|
2
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Proof-of-Mechanism Study to Determine the Effect of Danicopan on C3 Levels in Participants With C3G or IC-MPGN
Baseline characteristics by cohort
| Measure |
Group 1: Danicopan 100 mg TID (Sentinel)
n=2 Participants
Participants received 100 mg of danicopan TID during the Treatment Period.
|
Group 2: Danicopan up to 200 mg TID
n=4 Participants
Participants received not more than 200 mg of danicopan TID during the Treatment Period.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.50 years
STANDARD_DEVIATION 7.85 • n=5 Participants
|
30.00 years
STANDARD_DEVIATION 12.68 • n=7 Participants
|
28.50 years
STANDARD_DEVIATION 10.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 15Population: All participants who received at least 1 dose of danicopan and who had a baseline measurement and at least 1 measurement during the treatment period.
Serum C3 levels were measured by conventional Roche immunoturbidimetric assay method. Change from Baseline = Serum C3 levels on Day 15 - Baseline Serum C3 levels
Outcome measures
| Measure |
Group 1: Danicopan 100 mg TID (Sentinel)
n=2 Participants
Participants received 100 mg of danicopan TID during the Treatment Period.
|
Group 2: Danicopan up to 200 mg TID
n=4 Participants
Participants received not more than 200 mg of danicopan TID during the Treatment Period.
|
Total
n=6 Participants
All participants who received at least 1 dose of danicopan.
|
|---|---|---|---|
|
Change From Baseline In Serum C3 Complement Protein (C3) Levels On Day 15
Baseline
|
0.32 g/L
Standard Deviation 0.060
|
0.56 g/L
Standard Deviation 0.230
|
0.48 g/L
Standard Deviation 0.220
|
|
Change From Baseline In Serum C3 Complement Protein (C3) Levels On Day 15
Day 15
|
0.35 g/L
Standard Deviation 0.060
|
0.70 g/L
Standard Deviation 0.350
|
0.58 g/L
Standard Deviation 0.330
|
|
Change From Baseline In Serum C3 Complement Protein (C3) Levels On Day 15
Change from Baseline
|
0.03 g/L
Standard Deviation 0.000
|
0.14 g/L
Standard Deviation 0.140
|
0.11 g/L
Standard Deviation 0.120
|
PRIMARY outcome
Timeframe: Baseline, Day 15Population: All participants who received at least 1 dose of danicopan and who had a baseline measurement and at least 1 measurement during the treatment period.
Plasma Intact C3 level were measured by a novel multiplex assay method. Change from Baseline = Plasma Intact C3 levels on Day 15 - Baseline Plasma Intact C3 levels
Outcome measures
| Measure |
Group 1: Danicopan 100 mg TID (Sentinel)
n=2 Participants
Participants received 100 mg of danicopan TID during the Treatment Period.
|
Group 2: Danicopan up to 200 mg TID
n=4 Participants
Participants received not more than 200 mg of danicopan TID during the Treatment Period.
|
Total
n=6 Participants
All participants who received at least 1 dose of danicopan.
|
|---|---|---|---|
|
Change From Baseline In Plasma Intact C3 Level On Day 15
Baseline
|
39.50 μg/mL
Standard Deviation 0.710
|
58.25 μg/mL
Standard Deviation 47.910
|
52.00 μg/mL
Standard Deviation 38.360
|
|
Change From Baseline In Plasma Intact C3 Level On Day 15
Day 15
|
54.30 μg/mL
Standard Deviation 17.390
|
33.50 μg/mL
Standard Deviation 9.040
|
40.43 μg/mL
Standard Deviation 15.000
|
|
Change From Baseline In Plasma Intact C3 Level On Day 15
Change from Baseline
|
14.80 μg/mL
Standard Deviation 18.100
|
-24.75 μg/mL
Standard Deviation 50.970
|
-11.57 μg/mL
Standard Deviation 45.180
|
SECONDARY outcome
Timeframe: Baseline, Day 14Population: All participants who received at least 1 dose of danicopan and who had a baseline measurement and at least 1 measurement during the treatment period.
CP activity was measured in serum by the DiaSorin Complement Activation Enzyme (CAE) functional immunoassay method, which measures terminal complement complex formation following activation. Results are expressed in CAE units which are calculated relative to previously established CAE activity of a positive control serum. Change from Baseline = Total Complement CP Activity on Day 14 - Baseline Total Complement CP Activity
Outcome measures
| Measure |
Group 1: Danicopan 100 mg TID (Sentinel)
n=2 Participants
Participants received 100 mg of danicopan TID during the Treatment Period.
|
Group 2: Danicopan up to 200 mg TID
n=4 Participants
Participants received not more than 200 mg of danicopan TID during the Treatment Period.
|
Total
n=6 Participants
All participants who received at least 1 dose of danicopan.
|
|---|---|---|---|
|
Change From Baseline In Total Complement Classical Pathway (CP) Activity On Day 14
Day 14
|
41.50 CAE unit
Standard Deviation 23.330
|
96.75 CAE unit
Standard Deviation 23.680
|
78.33 CAE unit
Standard Deviation 35.490
|
|
Change From Baseline In Total Complement Classical Pathway (CP) Activity On Day 14
Change from Baseline
|
10.50 CAE unit
Standard Deviation 2.120
|
5.75 CAE unit
Standard Deviation 34.250
|
7.33 CAE unit
Standard Deviation 26.660
|
|
Change From Baseline In Total Complement Classical Pathway (CP) Activity On Day 14
Baseline
|
31.00 CAE unit
Standard Deviation 21.210
|
91.00 CAE unit
Standard Deviation 41.370
|
71.00 CAE unit
Standard Deviation 45.570
|
SECONDARY outcome
Timeframe: Baseline, Day 15Population: All participants who received at least 1 dose of danicopan and who had a baseline measurement and at least 1 measurement during the treatment period.
AP functional activity was measured in serum by the Wieslab functional immunoassay method, which measures terminal complement complex (TCC) formation following AP-specific activation. Results are expressed as percent TCC production relative to a positive control serum. Change from Baseline = Total Complement AP Functional Activity on Day 15 - Baseline Total Complement AP Functional Activity
Outcome measures
| Measure |
Group 1: Danicopan 100 mg TID (Sentinel)
n=2 Participants
Participants received 100 mg of danicopan TID during the Treatment Period.
|
Group 2: Danicopan up to 200 mg TID
n=4 Participants
Participants received not more than 200 mg of danicopan TID during the Treatment Period.
|
Total
n=6 Participants
All participants who received at least 1 dose of danicopan.
|
|---|---|---|---|
|
Change From Baseline In Total Complement Alternative Pathway (AP) Functional Activity (AP Wieslab) On Day 15
Day 15
|
1.635 percentage of activity
Standard Deviation 2.3122
|
0.993 percentage of activity
Standard Deviation 1.1101
|
1.207 percentage of activity
Standard Deviation 1.3852
|
|
Change From Baseline In Total Complement Alternative Pathway (AP) Functional Activity (AP Wieslab) On Day 15
Baseline
|
8.350 percentage of activity
Standard Deviation 10.508
|
31.073 percentage of activity
Standard Deviation 19.779
|
23.498 percentage of activity
Standard Deviation 19.862
|
|
Change From Baseline In Total Complement Alternative Pathway (AP) Functional Activity (AP Wieslab) On Day 15
Change from Baseline
|
-6.715 percentage of activity
Standard Deviation 8.1954
|
-30.08 percentage of activity
Standard Deviation 19.176
|
-22.29 percentage of activity
Standard Deviation 19.484
|
SECONDARY outcome
Timeframe: From The First Day Of Dosing through Day 14Population: All participants who received at least 1 dose of danicopan and who had a baseline measurement and at least 1 measurement during the treatment period.
Serial serum samples were collected on Days 1, 7, and 14.
Outcome measures
| Measure |
Group 1: Danicopan 100 mg TID (Sentinel)
n=2 Participants
Participants received 100 mg of danicopan TID during the Treatment Period.
|
Group 2: Danicopan up to 200 mg TID
n=4 Participants
Participants received not more than 200 mg of danicopan TID during the Treatment Period.
|
Total
n=6 Participants
All participants who received at least 1 dose of danicopan.
|
|---|---|---|---|
|
Time To Achieving Peak Serum C3 Levels
|
2.5 days
Standard Deviation 2.12
|
10.5 days
Standard Deviation 4.43
|
7.8 days
Standard Deviation 5.46
|
SECONDARY outcome
Timeframe: Up to Day 49Population: All participants who received at least 1 dose of danicopan and who had a baseline measurement and at least 1 measurement during the treatment period.
An AE was as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An SAE was an AE that met at least 1 of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization for the AE, persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug), important medical event or reaction. The intensity of an AE was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) Adverse Event Severity Grading Table. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Group 1: Danicopan 100 mg TID (Sentinel)
n=2 Participants
Participants received 100 mg of danicopan TID during the Treatment Period.
|
Group 2: Danicopan up to 200 mg TID
n=4 Participants
Participants received not more than 200 mg of danicopan TID during the Treatment Period.
|
Total
n=6 Participants
All participants who received at least 1 dose of danicopan.
|
|---|---|---|---|
|
Number Of Participants With Serious Adverse Events (SAEs), Grade 3 And Grade 4 Treatment-emergent Adverse Events (TEAEs), And Adverse Events (AEs) Leading To Discontinuation
TEAEs
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Number Of Participants With Serious Adverse Events (SAEs), Grade 3 And Grade 4 Treatment-emergent Adverse Events (TEAEs), And Adverse Events (AEs) Leading To Discontinuation
SAEs
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number Of Participants With Serious Adverse Events (SAEs), Grade 3 And Grade 4 Treatment-emergent Adverse Events (TEAEs), And Adverse Events (AEs) Leading To Discontinuation
TEAEs ≥Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number Of Participants With Serious Adverse Events (SAEs), Grade 3 And Grade 4 Treatment-emergent Adverse Events (TEAEs), And Adverse Events (AEs) Leading To Discontinuation
TEAEs leading to discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 1 and 7Population: All participants receiving at least 1 dose of danicopan who had a baseline measurement and at least 1 measurement during the treatment period.
Serial blood samples were collected at 0, 1, 1.5, 2, 2.5, 3, 4, 6, and 8 hours post-dose on Days 1 and 7.
Outcome measures
| Measure |
Group 1: Danicopan 100 mg TID (Sentinel)
n=2 Participants
Participants received 100 mg of danicopan TID during the Treatment Period.
|
Group 2: Danicopan up to 200 mg TID
n=1 Participants
Participants received not more than 200 mg of danicopan TID during the Treatment Period.
|
Total
n=3 Participants
All participants who received at least 1 dose of danicopan.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Area Under The Plasma Concentration-time Curve From Time Of Administration To 8 Hours Postdose (AUC0-8)
Day 1
|
871 h*ng/mL
Geometric Coefficient of Variation 38.1
|
2060 h*ng/mL
|
1640 h*ng/mL
Geometric Coefficient of Variation 42.8
|
|
Pharmacokinetics (PK): Area Under The Plasma Concentration-time Curve From Time Of Administration To 8 Hours Postdose (AUC0-8)
Day 7
|
1120 h*ng/mL
Geometric Coefficient of Variation 44.4
|
2470 h*ng/mL
|
1760 h*ng/mL
Geometric Coefficient of Variation 24.2
|
SECONDARY outcome
Timeframe: Days 1 and 7Population: All participants receiving at least 1 dose of danicopan who had a baseline measurement and at least 1 measurement during the treatment period.
Serial blood samples were collected at 0, 1, 1.5, 2, 2.5, 3, 4, 6, and 8 hours post-dose on Days 1 and 7.
Outcome measures
| Measure |
Group 1: Danicopan 100 mg TID (Sentinel)
n=2 Participants
Participants received 100 mg of danicopan TID during the Treatment Period.
|
Group 2: Danicopan up to 200 mg TID
n=1 Participants
Participants received not more than 200 mg of danicopan TID during the Treatment Period.
|
Total
n=3 Participants
All participants who received at least 1 dose of danicopan.
|
|---|---|---|---|
|
PK: Maximum Plasma Concentration (Cmax)
Day 1
|
199 ng/mL
Geometric Coefficient of Variation 6.75
|
563 ng/mL
|
427 ng/mL
Geometric Coefficient of Variation 46.3
|
|
PK: Maximum Plasma Concentration (Cmax)
Day 7
|
270 ng/mL
Geometric Coefficient of Variation 41.2
|
579 ng/mL
|
385 ng/mL
Geometric Coefficient of Variation 39.1
|
SECONDARY outcome
Timeframe: Days 1 and 7Population: All participants receiving at least 1 dose of danicopan who had a baseline measurement and at least 1 measurement during the treatment period.
Serial blood samples were collected at 0, 1, 1.5, 2, 2.5, 3, 4, 6, and 8 hours post-dose on Days 1 and 7.
Outcome measures
| Measure |
Group 1: Danicopan 100 mg TID (Sentinel)
n=2 Participants
Participants received 100 mg of danicopan TID during the Treatment Period.
|
Group 2: Danicopan up to 200 mg TID
n=1 Participants
Participants received not more than 200 mg of danicopan TID during the Treatment Period.
|
Total
n=3 Participants
All participants who received at least 1 dose of danicopan.
|
|---|---|---|---|
|
PK: Time To Maximum Concentration (Tmax)
Day 1
|
1.00 hours
Interval 1.0 to 1.0
|
2.50 hours
Interval 2.5 to 2.5
|
2.00 hours
Interval 1.5 to 2.0
|
|
PK: Time To Maximum Concentration (Tmax)
Day 7
|
2.75 hours
Interval 1.5 to 4.0
|
2.50 hours
Interval 2.5 to 2.5
|
1.50 hours
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Baseline, Day 15Population: All participants who received at least 1 dose of danicopan and who had a baseline measurement and at least 1 measurement during the treatment period.
Plasma Bb was measured by enzyme-linked immunosorbent assay (ELISA). Change from Baseline = Complement Bb on Day 15 - Baseline
Outcome measures
| Measure |
Group 1: Danicopan 100 mg TID (Sentinel)
n=2 Participants
Participants received 100 mg of danicopan TID during the Treatment Period.
|
Group 2: Danicopan up to 200 mg TID
n=4 Participants
Participants received not more than 200 mg of danicopan TID during the Treatment Period.
|
Total
n=6 Participants
All participants who received at least 1 dose of danicopan.
|
|---|---|---|---|
|
Change From Baseline In Bb Fragment Of Complement Factor B (Bb) At Day 15
Baseline
|
1.789 µg/mL
Standard Deviation 1.2116
|
1.229 µg/mL
Standard Deviation 0.4729
|
1.416 µg/mL
Standard Deviation 0.7152
|
|
Change From Baseline In Bb Fragment Of Complement Factor B (Bb) At Day 15
Day 15
|
1.511 µg/mL
Standard Deviation 0.9781
|
0.622 µg/mL
Standard Deviation 0.3349
|
0.918 µg/mL
Standard Deviation 0.6854
|
|
Change From Baseline In Bb Fragment Of Complement Factor B (Bb) At Day 15
Change from baseline
|
-0.278 µg/mL
Standard Deviation 0.2335
|
-0.607 µg/mL
Standard Deviation 0.1790
|
-0.497 µg/mL
Standard Deviation 0.2430
|
SECONDARY outcome
Timeframe: Baseline, Day 15Population: All participants who received at least 1 dose of danicopan and who had a baseline measurement and at least 1 measurement during the treatment period.
Plasma sC5b-9 was measured by ELISA. Change from Baseline = sC5b-9 on Day 15 - Baseline sC5b-9
Outcome measures
| Measure |
Group 1: Danicopan 100 mg TID (Sentinel)
n=2 Participants
Participants received 100 mg of danicopan TID during the Treatment Period.
|
Group 2: Danicopan up to 200 mg TID
n=4 Participants
Participants received not more than 200 mg of danicopan TID during the Treatment Period.
|
Total
n=6 Participants
All participants who received at least 1 dose of danicopan.
|
|---|---|---|---|
|
Change From Baseline In Soluble Terminal Complement Complex (sC5b-9) At Day 15
Baseline
|
1002.0 ng/mL
Standard Deviation 684.4794
|
613.750 ng/mL
Standard Deviation 225.2397
|
743.167 ng/mL
Standard Deviation 405.3874
|
|
Change From Baseline In Soluble Terminal Complement Complex (sC5b-9) At Day 15
Day 15
|
1105.5 ng/mL
Standard Deviation 622.9611
|
563.850 ng/mL
Standard Deviation 302.4446
|
744.400 ng/mL
Standard Deviation 459.0596
|
|
Change From Baseline In Soluble Terminal Complement Complex (sC5b-9) At Day 15
Change from Baseline
|
103.500 ng/mL
Standard Deviation 61.5183
|
-49.900 ng/mL
Standard Deviation 237.1917
|
1.233 ng/mL
Standard Deviation 201.9602
|
Adverse Events
Group 1: Danicopan 100 mg TID (Sentinel)
Group 2: Danicopan up to 200 mg TID
Serious adverse events
| Measure |
Group 1: Danicopan 100 mg TID (Sentinel)
n=2 participants at risk
Participants received 100 mg of danicopan TID during the Treatment Period.
|
Group 2: Danicopan up to 200 mg TID
n=4 participants at risk
Participants received not more than 200 mg of danicopan TID during the Treatment Period.
|
|---|---|---|
|
Nervous system disorders
Presyncope
|
0.00%
0/2 • After the first dose of study medication (following Day 0) through the follow-up visit at Day 49.
\[Not specified\]
|
25.0%
1/4 • After the first dose of study medication (following Day 0) through the follow-up visit at Day 49.
\[Not specified\]
|
Other adverse events
| Measure |
Group 1: Danicopan 100 mg TID (Sentinel)
n=2 participants at risk
Participants received 100 mg of danicopan TID during the Treatment Period.
|
Group 2: Danicopan up to 200 mg TID
n=4 participants at risk
Participants received not more than 200 mg of danicopan TID during the Treatment Period.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
1/2 • After the first dose of study medication (following Day 0) through the follow-up visit at Day 49.
\[Not specified\]
|
25.0%
1/4 • After the first dose of study medication (following Day 0) through the follow-up visit at Day 49.
\[Not specified\]
|
|
Nervous system disorders
Dizziness
|
50.0%
1/2 • After the first dose of study medication (following Day 0) through the follow-up visit at Day 49.
\[Not specified\]
|
0.00%
0/4 • After the first dose of study medication (following Day 0) through the follow-up visit at Day 49.
\[Not specified\]
|
|
Infections and infestations
Upper respiratory tract infection
|
50.0%
1/2 • After the first dose of study medication (following Day 0) through the follow-up visit at Day 49.
\[Not specified\]
|
0.00%
0/4 • After the first dose of study medication (following Day 0) through the follow-up visit at Day 49.
\[Not specified\]
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
50.0%
1/2 • After the first dose of study medication (following Day 0) through the follow-up visit at Day 49.
\[Not specified\]
|
0.00%
0/4 • After the first dose of study medication (following Day 0) through the follow-up visit at Day 49.
\[Not specified\]
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
1/2 • After the first dose of study medication (following Day 0) through the follow-up visit at Day 49.
\[Not specified\]
|
0.00%
0/4 • After the first dose of study medication (following Day 0) through the follow-up visit at Day 49.
\[Not specified\]
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • After the first dose of study medication (following Day 0) through the follow-up visit at Day 49.
\[Not specified\]
|
25.0%
1/4 • After the first dose of study medication (following Day 0) through the follow-up visit at Day 49.
\[Not specified\]
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • After the first dose of study medication (following Day 0) through the follow-up visit at Day 49.
\[Not specified\]
|
25.0%
1/4 • After the first dose of study medication (following Day 0) through the follow-up visit at Day 49.
\[Not specified\]
|
|
General disorders
Pain
|
0.00%
0/2 • After the first dose of study medication (following Day 0) through the follow-up visit at Day 49.
\[Not specified\]
|
25.0%
1/4 • After the first dose of study medication (following Day 0) through the follow-up visit at Day 49.
\[Not specified\]
|
|
General disorders
Crepitations
|
0.00%
0/2 • After the first dose of study medication (following Day 0) through the follow-up visit at Day 49.
\[Not specified\]
|
25.0%
1/4 • After the first dose of study medication (following Day 0) through the follow-up visit at Day 49.
\[Not specified\]
|
|
Renal and urinary disorders
Prerenal failure
|
0.00%
0/2 • After the first dose of study medication (following Day 0) through the follow-up visit at Day 49.
\[Not specified\]
|
25.0%
1/4 • After the first dose of study medication (following Day 0) through the follow-up visit at Day 49.
\[Not specified\]
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/2 • After the first dose of study medication (following Day 0) through the follow-up visit at Day 49.
\[Not specified\]
|
25.0%
1/4 • After the first dose of study medication (following Day 0) through the follow-up visit at Day 49.
\[Not specified\]
|
Additional Information
Alexion Pharmaceuticals Inc.
Alexion Pharmaceuticals Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place