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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003135-35 | EudraCT Number |
Not provided
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Terminated for administrative reasons before enrollment was complete.
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This was a prospective, open-label study with no participant randomization. Treatment for aHUS was observational and at the discretion of the treating physician. The purpose of this study was to assess disease manifestations of complement-mediated thrombotic microangiopathy (TMA) and evaluate potential clinical predictors of disease manifestations and progression in participants with aHUS with or without eculizumab treatment in the clinical setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eculizumab | The targeted population consists of pediatric and adult participants with aHUS who received eculizumab at the discretion of the treating physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eculizumab | Other | This study was an observational study. Therefore, the study drug was not provided as part of this study, and the dosing regimen was based solely at the discretion of the treating physician. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate Of Thrombotic Microangiopathy (TMA) Manifestations During Eculizumab Treatment Compared To Off-Treatment | A TMA manifestation was defined as one of following: Hematologic or renal events due to aHUS; extra-renal clinical signs and symptoms of aHUS; tissue (for example, kidney transplant) biopsy demonstrating TMA due to aHUS. The study was terminated with only 20% of the planned enrollment and due to the subsequent loss of funding for the program, the samples collected for outcome measure assessment could not be analyzed to generate summary-level data. All participants enrolled in ECU-aHUS-403 were concurrently enrolled in protocol M11-001, and their data will be included in the analyses for M11-001. | Baseline, 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline To 24 Months In Estimated Glomerular Filtration Rate (eGFR) | Change in estimated eGFR over time using the chronic kidney disease-epidemiology (CKD-EPI) formula. The study was terminated with only 20% of the planned enrollment and due to the subsequent loss of funding for the program, the samples collected for outcome measure assessment could not be analyzed to generate summary-level data. All participants enrolled in ECU-aHUS-403 were concurrently enrolled in protocol M11-001, and their data will be included in the analyses for M11-001. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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Participants with aHUS enrolled in the M11-001 aHUS Registry and currently receiving eculizumab with no prior intentional eculizumab discontinuations at any time (for example, not occasional, unplanned, or temporary missed doses of eculizumab, but intended long-term discontinuation).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Washington D.C. | District of Columbia | 20007 | United States | ||
| Clinical Trial Site |
Sixty-seven participants were enrolled in this study (15 pediatric and 52 adults). Treatment information was missing for 1 adult participant.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pediatric | Participants with atypical hemolytic uremic syndrome (aHUS) who were less than 18 years at baseline and who initiated treatment with eculizumab prior to study entry. Dosing regimen changed solely at the discretion of the treating physician. |
| FG001 | Adult |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 5, 2015 |
Not provided
Not provided
Not provided
Not provided
|
| Baseline, 24 Months |
| Incidence Of Plasma Exchange And Plasma Infusion (PE/PI) | The number of occurrences of PE/PI per participant-years was calculated and summarized by treatment status. The study was terminated with only 20% of the planned enrollment and due to the subsequent loss of funding for the program, the samples collected for outcome measure assessment could not be analyzed to generate summary-level data. All participants enrolled in ECU-aHUS-403 were concurrently enrolled in protocol M11-001, and their data will be included in the analyses for M11-001. | Baseline, 24 Months |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Clinical Trial Site | Chicago | Illinois | 60611 | United States |
| Clinical Trial Site | Boston | Massachusetts | 02115 | United States |
| Clinical Trial Site | Hackensack | New Jersey | 07601 | United States |
| Clinical Trial Site | Charlotte | North Carolina | 28203 | United States |
| Clinical Trial Site | Columbus | Ohio | 43210 | United States |
| Clinical Trial Site | Houston | Texas | 77030 | United States |
| Clinical Trial Site | Adelaide | 5000 | Australia |
| Clinical Trial Site | Clayton | 3168 | Australia |
| Clinical Trial Site | Heidelberg | 3084 | Australia |
| Clinical Trial Site | Kingswood | 2747 | Australia |
| Clinical Trial Site | Liverpool | 2170 | Australia |
| Clinical Trial Site | Nedlands | 6109 | Australia |
| Clinical Trial Site | Parkville | 3050 | Australia |
| Clinical Trial Site | Parkville | 3052 | Australia |
| Clinical Trial Site | Perth | 6008 | Australia |
| Clinical Trial Site | Westmead | 2145 | Australia |
| Clinical Trial Site | Woolloongabba | 4102 | Australia |
| Clinical Trial Site | Hannover | 30625 | Germany |
| Clinical Trial Site | Hanover | 30625 | Germany |
| Clinical Trial Site | Kiel | 24105 | Germany |
| Clinical Trial Site | Lübeck | 23538 | Germany |
| Clinical Trial Site | London | NW3 2PF | United Kingdom |
Participants with aHUS who were 18 years or older at baseline and who initiated treatment with eculizumab prior to study entry. Dosing regimen changed solely at the discretion of the treating physician. |
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All enrolled participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pediatric | Participants with aHUS who were less than 18 years at baseline and who initiated treatment with eculizumab prior to study entry. Dosing regimen changed solely at the discretion of the treating physician. |
| BG001 | Adult | Participants with aHUS who were 18 years or older at baseline and who initiated treatment with eculizumab prior to study entry. Dosing regimen changed solely at the discretion of the treating physician. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate Of Thrombotic Microangiopathy (TMA) Manifestations During Eculizumab Treatment Compared To Off-Treatment | A TMA manifestation was defined as one of following: Hematologic or renal events due to aHUS; extra-renal clinical signs and symptoms of aHUS; tissue (for example, kidney transplant) biopsy demonstrating TMA due to aHUS. The study was terminated with only 20% of the planned enrollment and due to the subsequent loss of funding for the program, the samples collected for outcome measure assessment could not be analyzed to generate summary-level data. All participants enrolled in ECU-aHUS-403 were concurrently enrolled in protocol M11-001, and their data will be included in the analyses for M11-001. | All enrolled participants. The study was terminated with only 20% of the planned enrollment; because the program lost funding, samples collected could not be analyzed to generate summary-level data. All participants enrolled in ECU-aHUS-403 were concurrently enrolled in protocol M11-001, and their data will be included in the analyses for M11-001. | Posted | Baseline, 24 Months |
|
| ||||||||||||||||||||||
| Secondary | Change From Baseline To 24 Months In Estimated Glomerular Filtration Rate (eGFR) | Change in estimated eGFR over time using the chronic kidney disease-epidemiology (CKD-EPI) formula. The study was terminated with only 20% of the planned enrollment and due to the subsequent loss of funding for the program, the samples collected for outcome measure assessment could not be analyzed to generate summary-level data. All participants enrolled in ECU-aHUS-403 were concurrently enrolled in protocol M11-001, and their data will be included in the analyses for M11-001. | All enrolled participants. The study was terminated with only 20% of the planned enrollment; because the program lost funding, samples collected could not be analyzed to generate summary-level data. All participants enrolled in ECU-aHUS-403 were concurrently enrolled in protocol M11-001, and their data will be included in the analyses for M11-001. | Posted | Baseline, 24 Months |
| |||||||||||||||||||||||
| Secondary | Incidence Of Plasma Exchange And Plasma Infusion (PE/PI) | The number of occurrences of PE/PI per participant-years was calculated and summarized by treatment status. The study was terminated with only 20% of the planned enrollment and due to the subsequent loss of funding for the program, the samples collected for outcome measure assessment could not be analyzed to generate summary-level data. All participants enrolled in ECU-aHUS-403 were concurrently enrolled in protocol M11-001, and their data will be included in the analyses for M11-001. | All enrolled participants. The study was terminated with only 20% of the planned enrollment; because the program lost funding, samples collected could not be analyzed to generate summary-level data. All participants enrolled in ECU-aHUS-403 were concurrently enrolled in protocol M11-001, and their data will be included in the analyses for M11-001. | Posted | Baseline, 24 Months |
|
Day 0 through Month 24
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pediatric | Participants with aHUS who were less than 18 years at baseline and who initiated treatment with eculizumab prior to study entry. Dosing regimen changed solely at the discretion of the treating physician. | 0 | 15 | 1 | 15 | 6 | 15 |
| EG001 | Adult | Participants with aHUS who were 18 years or older at baseline and who initiated treatment with eculizumab prior to study entry. Dosing regimen changed solely at the discretion of the treating physician. | 0 | 52 | 14 | 52 | 31 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Cellulitis streptococcal | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Metapneumovirus infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Arteriovenous fistula occlusion | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Drug abuse | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Acute lung injury | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Increased tendency to bruise | Blood and lymphatic system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Nephrogenic anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Inner ear inflammation | Ear and labyrinth disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Blindness unilateral | Eye disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Eye colour change | Eye disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Ocular icterus | Eye disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Orbital oedema | Eye disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Anorectal discomfort | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Bowel movement irregularity | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Gastrointestinal erosion | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Malabsorption | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Catheter site erythema | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Extravasation | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Temperature intolerance | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Aeromonas infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Varicella zoster virus infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Anal injury | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Bone density decreased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Faecal calprotectin increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Faecal elastase concentration decreased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Haptoglobin decreased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Red blood cell schistocytes present | Investigations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Angiolipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
| |
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hypotonia | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Poor quality sleep | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Renal tubular acidosis | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Amenorrhoea | Reproductive system and breast disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Breast cyst | Reproductive system and breast disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
As the study was terminated for administrative reasons, before enrollment was complete, and the program subsequently lost funding, all collected data could not be analyzed to generate summary-level data.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexion Pharmaceuticals, Inc. | Alexion Pharmaceuticals, Inc. | 475-230-2596 | clinicaltrials@alexion.com |
| May 14, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D065766 | Atypical Hemolytic Uremic Syndrome |
| ID | Term |
|---|---|
| D006463 | Hemolytic-Uremic Syndrome |
| D014511 | Uremia |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
Not provided
Not provided
| ID | Term |
|---|---|
| C481642 | eculizumab |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Black |
|
| Other |
|
| Units | Counts |
|---|---|
| Participants |
|
| Units | Counts |
|---|---|
| Participants |
|