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Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02949128
Recruitment Status : Active, not recruiting
First Posted : October 31, 2016
Results First Posted : February 10, 2020
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Atypical Hemolytic Uremic Syndrome (aHUS)
Intervention Biological: Ravulizumab
Enrollment 58
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ravulizumab
Hide Arm/Group Description

Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.

After the Initial Evaluation Period, participants could enter an Extension Period and receive ravulizumab until the product registration or approval (in accordance with country-specific regulations) or for up to 4.5 years, whichever occurs first.

Period Title: Initial Evaluation Period
Started 58
Received At Least 1 Dose of Study Drug 58
Completed [1] 49
Not Completed 9
Reason Not Completed
Failed to Meet Eligibility Criteria             2
Adverse Event             3
Death             2
Physician Decision             1
Protocol Violation             1
[1]
Completed the Initial Evaluation Period
Period Title: Extension Period
Started 49
Received At Least 1 Dose of Study Drug 47
Completed [1] 47
Not Completed 2
Reason Not Completed
Physician Decision             1
Withdrawal by Subject             1
[1]
Ongoing in Extension Period as of 10/18/2018
Arm/Group Title Ravulizumab
Hide Arm/Group Description

Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.

After the Initial Evaluation Period, participants could enter an Extension Period and receive ravulizumab until the product registration or approval (in accordance with country-specific regulations) or for up to 4.5 years, whichever occurs first.

Overall Number of Baseline Participants 56
Hide Baseline Analysis Population Description
Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, and met pre-specified eligibility criteria.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants
42.2  (14.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants
Female
37
  66.1%
Male
19
  33.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants
Hispanic or Latino
3
   5.4%
Not Hispanic or Latino
41
  73.2%
Unknown or Not Reported
12
  21.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants
American Indian or Alaska Native
1
   1.8%
Asian
15
  26.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   3.6%
White
29
  51.8%
More than one race
0
   0.0%
Unknown or Not Reported
9
  16.1%
1.Primary Outcome
Title Proportion Of Participants With Complete Thrombotic Microangiopathy (TMA) Response
Hide Description Complete TMA response during the 26-week Initial Evaluation Period is a composite outcome measure that required normalization of hematological parameters (platelet count and lactate dehydrogenase [LDH]) and improvement in kidney function (≥25% reduction in serum creatinine from baseline); for participants on dialysis, baseline was established at least 6 days after the end of dialysis. Participants had to meet these criteria for 2 separate assessments obtained at least 4 weeks (28 days) apart, and any measurement in between. To be considered a responder during the 26-week Initial Evaluation Period, the latest time point a participant could first meet the response criteria was 28 days before the Week 26 (Day 183) assessment. Formal statistical comparison analyses were not planned for this study. The proportion was based on the responders among treated participants. The 95% confidence interval (CI) was based on the asymptotic Gaussian approximation method with a continuity correction.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, and met pre-specified eligibility criteria.
Arm/Group Title Ravulizumab
Hide Arm/Group Description:
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.
Overall Number of Participants Analyzed 56
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.54
(0.40 to 0.67)
2.Secondary Outcome
Title Time To Complete TMA Response
Hide Description Participants that did not have a response were censored at the date of last visit or study discontinuation at the time when the analysis was performed. The time to complete TMA Response is reported in days. The time of the event of a confirmed complete TMA response was considered the first time point at which all the criteria for complete TMA response were met.
Time Frame Baseline through Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, and met pre-specified eligibility criteria.
Arm/Group Title Ravulizumab
Hide Arm/Group Description:
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.
Overall Number of Participants Analyzed 56
Median (Inter-Quartile Range)
Unit of Measure: days
86.0 [1] 
(42.0 to NA)
[1]
Participants who did not have a response were censored at the date of last visit or study discontinuation.
3.Secondary Outcome
Title Proportion Of Participants With Complete TMA Response At Week 26
Hide Description The proportion of participants considered responders, along with a 2-sided 95% CI for the Week 26 time point, is reported. To be considered a responder during the 26-week Initial Evaluation Period, the latest time point a participant could first meet the response criteria was 28 days before the Week 26 (Day 183) assessment (components of the response maintained for at least 28 days).
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at specified timepoint (Week 26).
Arm/Group Title Ravulizumab
Hide Arm/Group Description:
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.
Overall Number of Participants Analyzed 49
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.531
(0.383 to 0.675)
4.Secondary Outcome
Title Observed Value And Change From Baseline In Estimated Glomerular Filtration Rate (eGFR) At Week 26
Hide Description Kidney function evaluated by eGFR was summarized at baseline and the Week 26 time point using descriptive statistics for continuous variables for the observed value, as well as the change from baseline. The baseline value was defined as the average of the values from the assessments performed prior to the first study drug infusion (these could include results from Screening and the Day 1 visit). A value of 10 milliliters (mL)/minute (min)/1.73 meters squared (m^2) for eGFR was imputed for participants requiring dialysis for acute kidney injury. The observed value and change from baseline are reported in mL/min/1.73 m^2. An increase indicated improvement in kidney function.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at specified timepoint (Week 26).
Arm/Group Title Ravulizumab
Hide Arm/Group Description:
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.
Overall Number of Participants Analyzed 56
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73 m^2
Observed Value Number Analyzed 48 participants
51.83  (39.162)
Change From Baseline Number Analyzed 47 participants
34.80  (35.454)
5.Secondary Outcome
Title Proportion Of Participants With Change From Baseline In Chronic Kidney Disease (CKD) Stage At Week 26
Hide Description The CKD stage is presented as the change from baseline in the proportion of participants that Improved (excluding those with Stage 1 [normal renal function] at baseline as they cannot improve), Worsened (excluding those with Stage 5 at baseline as they cannot worsen), and Stayed the Same, compared to the CKD stage at baseline. Baseline was derived based on the last available eGFR before starting treatment. Stage 5 was considered the worst category, while Stage 1 was considered the best category. A 2-sided 95% CI for the proportion, based on exact confidence limits using the Clopper-Pearson method, was provided for each category. The CKD stage was classified based on the National Kidney Foundation Chronic Kidney Disease Stage.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at specified timepoint (Week 26).
Arm/Group Title Ravulizumab
Hide Arm/Group Description:
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.
Overall Number of Participants Analyzed 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
Improved Number Analyzed 32 participants
0.681
(0.529 to 0.809)
Worsened Number Analyzed 2 participants
0.154
(0.019 to 0.454)
Stayed the Same Number Analyzed 13 participants
0.277
(0.156 to 0.426)
6.Secondary Outcome
Title Change From Baseline In Platelet Count At Week 26
Hide Description The hematologic TMA parameter of platelet count was summarized at baseline and at Week 26 using descriptive statistics for continuous variables for the change from baseline. Results are reported in platelets*10^9/liter (L) blood.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at specified timepoint (Week 26).
Arm/Group Title Ravulizumab
Hide Arm/Group Description:
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: platelets*10^9/L
114.79  (105.568)
7.Secondary Outcome
Title Change From Baseline In LDH At Week 26
Hide Description The hematologic TMA parameter of serum LDH was summarized at baseline and at Week 26 using descriptive statistics for continuous variables for the change from baseline. Results are reported in units (U)/L.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at specified timepoint (Week 26).
Arm/Group Title Ravulizumab
Hide Arm/Group Description:
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: U/L
-519.83  (572.467)
8.Secondary Outcome
Title Change From Baseline In Hemoglobin At Week 26
Hide Description The hematologic TMA parameter of hemoglobin level was summarized at baseline and at Week 26 using descriptive statistics for continuous variables for the change from baseline. Results are reported in grams (g)/L.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at specified timepoint (Week 26).
Arm/Group Title Ravulizumab
Hide Arm/Group Description:
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: g/L
34.64  (18.087)
9.Secondary Outcome
Title Proportion Of Participants With An Increase From Baseline In Hemoglobin ≥ 20 g/L Through Week 26
Hide Description The proportion of participants with an increase from baseline in hemoglobin ≥ 20 g/L, observed at 2 separate assessments obtained at least 4 weeks (28 days) apart, and any measurement in between, was assessed through Week 26 and is presented as the proportion of responders, along with a 2-sided 95% CI. The 95% CIs are based on the asymptotic Gaussian approximation method with a continuity correction. To be considered a responder during the 26-week Initial Evaluation Period, the latest time point a participant could first meet the response criteria was 28 days before the Week 26 (Day 183) assessment (components of the response maintained for at least 28 days).
Time Frame Up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at specified timepoint (Week 26).
Arm/Group Title Ravulizumab
Hide Arm/Group Description:
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.
Overall Number of Participants Analyzed 56
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.714
(0.587 to 0.842)
10.Secondary Outcome
Title Change From Baseline In Quality Of Life As Measured By The EuroQol 5-Dimension 3-Level (EQ-5D-3L) At Week 26
Hide Description The EQ-5D-3L is a participant-answered questionnaire that scores 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (scored as a 1, 2, or 3, with 3 being the worst health state), as well as health state on a visual analogue scale (0 to 100, with 100 representing the best health state). From these scores, a summary index score is derived using the time trade-off valuation set for the United States and ranges from -1 to 1, where a score above 0.94 indicates full health. An increase in score from baseline indicates improvement in quality of life.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at specified timepoint (Week 26).
Arm/Group Title Ravulizumab
Hide Arm/Group Description:
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.
Overall Number of Participants Analyzed 46
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.32  (0.324)
11.Secondary Outcome
Title Change From Baseline In Quality Of Life As Measured By The Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Version 4 Questionnaire At Week 26
Hide Description Quality of life was evaluated in part using FACIT Fatigue Version 4. The data were summarized at baseline and at the Week 26 time point using descriptive statistics for continuous variables. The FACIT Fatigue Version 4 questionnaire at baseline and the Week 26 timepoint was scored using standard scoring algorithms. The score ranges from 0-52, with a higher score indicating less Fatigue. An increase in score indicated an improvement in quality of life.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at specified timepoint (Week 26).
Arm/Group Title Ravulizumab
Hide Arm/Group Description:
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.
Overall Number of Participants Analyzed 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
19.15  (16.212)
Time Frame From the beginning of the initial evaluation period (Day1) through data cutoff (at least 26 weeks and up to a maximum of 81 weeks of treatment, representing 46.3 patient-years of exposure).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ravulizumab
Hide Arm/Group Description

Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.

After the Initial Evaluation Period, participants could enter an Extension Period and receive ravulizumab until the product registration or approval (in accordance with country-specific regulations) or for up to 4.5 years, whichever occurs first.

All-Cause Mortality
Ravulizumab
Affected / at Risk (%)
Total   4/58 (6.90%) 
Hide Serious Adverse Events
Ravulizumab
Affected / at Risk (%)
Total   30/58 (51.72%) 
Blood and lymphatic system disorders   
Atypical haemolytic uraemic syndrome  1  2/58 (3.45%) 
Autoimmune haemolytic anaemia  1  1/58 (1.72%) 
Febrile neutropenia  1  1/58 (1.72%) 
Immune thrombocytopenic purpura  1  1/58 (1.72%) 
Thrombocytopenia  1  1/58 (1.72%) 
Ear and labyrinth disorders   
Vertigo positional  1  1/58 (1.72%) 
Eye disorders   
Vitreous haemorrhage  1  1/58 (1.72%) 
Gastrointestinal disorders   
Abdominal pain  1  1/58 (1.72%) 
Diarrhoea  1  1/58 (1.72%) 
Lower gastrointestinal haemorrhage  1  1/58 (1.72%) 
Toothache  1  1/58 (1.72%) 
Immune system disorders   
Hypersensitivity  1  1/58 (1.72%) 
Kidney transplant rejection  1  1/58 (1.72%) 
Infections and infestations   
Pneumonia  1  3/58 (5.17%) 
Septic shock  1  2/58 (3.45%) 
Urinary tract infection  1  2/58 (3.45%) 
Device related infection  1  1/58 (1.72%) 
Escherichia pyelonephritis  1  1/58 (1.72%) 
Fungaemia  1  1/58 (1.72%) 
Gastrointestinal infection  1  1/58 (1.72%) 
Infectious colitis  1  1/58 (1.72%) 
Peritonitis bacterial  1  1/58 (1.72%) 
Pharyngitis  1  1/58 (1.72%) 
Sepsis  1  1/58 (1.72%) 
Sinusitis  1  1/58 (1.72%) 
Injury, poisoning and procedural complications   
Seroma  1  1/58 (1.72%) 
Shunt occlusion  1  1/58 (1.72%) 
Investigations   
Biopsy kidney  1  1/58 (1.72%) 
Troponin increased  1  1/58 (1.72%) 
Metabolism and nutrition disorders   
Hypervolaemia  1  1/58 (1.72%) 
Hypokalaemia  1  1/58 (1.72%) 
Nervous system disorders   
Haemorrhage intracranial  1  1/58 (1.72%) 
Lacunar infarction  1  1/58 (1.72%) 
Loss of consciousness  1  1/58 (1.72%) 
Seizure  1  1/58 (1.72%) 
Product Issues   
Device leakage  1  1/58 (1.72%) 
Renal and urinary disorders   
Acute kidney injury  1  1/58 (1.72%) 
Chronic kidney disease  1  1/58 (1.72%) 
Hydronephrosis  1  1/58 (1.72%) 
Nephrolithiasis  1  1/58 (1.72%) 
Renal failure  1  1/58 (1.72%) 
Renal haematoma  1  1/58 (1.72%) 
Renal impairment  1  1/58 (1.72%) 
Renal pseudoaneurysm  1  1/58 (1.72%) 
Respiratory, thoracic and mediastinal disorders   
Acute pulmonary oedema  1  1/58 (1.72%) 
Dyspnoea  1  1/58 (1.72%) 
Hypoxia  1  1/58 (1.72%) 
Pulmonary oedema  1  1/58 (1.72%) 
Respiratory disorder  1  1/58 (1.72%) 
Respiratory failure  1  1/58 (1.72%) 
Vascular disorders   
Hypertension  1  3/58 (5.17%) 
Malignant hypertension  1  2/58 (3.45%) 
Hypertensive crisis  1  1/58 (1.72%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ravulizumab
Affected / at Risk (%)
Total   56/58 (96.55%) 
Blood and lymphatic system disorders   
Anaemia  1  8/58 (13.79%) 
Thrombocytopenia  1  3/58 (5.17%) 
Cardiac disorders   
Palpitations  1  3/58 (5.17%) 
Eye disorders   
Vision blurred  1  4/58 (6.90%) 
Gastrointestinal disorders   
Diarrhoea  1  18/58 (31.03%) 
Vomiting  1  15/58 (25.86%) 
Nausea  1  13/58 (22.41%) 
Constipation  1  8/58 (13.79%) 
Abdominal pain  1  6/58 (10.34%) 
Dyspepsia  1  4/58 (6.90%) 
General disorders   
Pyrexia  1  10/58 (17.24%) 
Oedema peripheral  1  9/58 (15.52%) 
Fatigue  1  7/58 (12.07%) 
Pain  1  4/58 (6.90%) 
Asthenia  1  3/58 (5.17%) 
Face oedema  1  3/58 (5.17%) 
Immune system disorders   
Drug hypersensitivity  1  3/58 (5.17%) 
Infections and infestations   
Urinary tract infection  1  10/58 (17.24%) 
Nasopharyngitis  1  8/58 (13.79%) 
Oral herpes  1  3/58 (5.17%) 
Injury, poisoning and procedural complications   
Contusion  1  3/58 (5.17%) 
Investigations   
Alanine aminotransferase increased  1  5/58 (8.62%) 
Aspartate aminotransferase increased  1  4/58 (6.90%) 
C-reactive protein increased  1  3/58 (5.17%) 
Metabolism and nutrition disorders   
Hypokalaemia  1  9/58 (15.52%) 
Hyperkalaemia  1  4/58 (6.90%) 
Vitamin D deficiency  1  4/58 (6.90%) 
Decreased appetite  1  3/58 (5.17%) 
Hyperphosphataemia  1  3/58 (5.17%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  10/58 (17.24%) 
Back pain  1  6/58 (10.34%) 
Muscle spasms  1  5/58 (8.62%) 
Pain in extremity  1  5/58 (8.62%) 
Nervous system disorders   
Headache  1  21/58 (36.21%) 
Dizziness  1  4/58 (6.90%) 
Somnolence  1  3/58 (5.17%) 
Psychiatric disorders   
Anxiety  1  8/58 (13.79%) 
Insomnia  1  4/58 (6.90%) 
Renal and urinary disorders   
End stage renal disease  1  3/58 (5.17%) 
Haematuria  1  3/58 (5.17%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  10/58 (17.24%) 
Dyspnoea  1  9/58 (15.52%) 
Epistaxis  1  3/58 (5.17%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  6/58 (10.34%) 
Dry Skin  1  6/58 (10.34%) 
Rash  1  5/58 (8.62%) 
Pruritus  1  3/58 (5.17%) 
Vascular disorders   
Hypertension  1  11/58 (18.97%) 
Hypotension  1  4/58 (6.90%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alexion Pharmaceuticals Inc.
Organization: Alexion Pharmaceuticals Inc.
Phone: 855-752-2356
EMail: clinicaltrials@alexion.com
Layout table for additonal information
Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02949128    
Other Study ID Numbers: ALXN1210-aHUS-311
2016‐002027‐29 ( EudraCT Number )
First Submitted: October 25, 2016
First Posted: October 31, 2016
Results First Submitted: December 11, 2019
Results First Posted: February 10, 2020
Last Update Posted: May 5, 2020