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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005328-13 | EudraCT Number |
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Recruitment Challenges
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This study will investigate the efficacy and safety of ravulizumab compared to placebo in adult participants with thrombotic microangiopathy (TMA) associated with a trigger. Participants will be randomized to receive either ravulizumab plus best supportive care or placebo plus best supportive care. The treatment period is 26 weeks followed by a 26-week off-treatment follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ravulizumab | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ravulizumab | Biological | Body weight-based doses of ravulizumab will be administered intravenously as loading dose regimen followed by maintenance dosing every 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete Thrombotic Microangiopathy (TMA) Response at Week 26 | TMA response required the following: 1) Normalization of platelet count without transfusion support during the prior 7 days. 2) Normalization of LDH. 3) Improvement in glomerular filtration rate (eGFR) of >= 30% compared to baseline. Participants must meet each TMA criterion at 2 separate assessments obtained at least 24 hours apart, and any measurement in between. | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Complete TMA Response | The Kaplan-Meier estimate of time to event of complete TMA response is reported. TMA response required the following: 1) Normalization of platelet count without transfusion support during the prior 7 days. 2) Normalization of LDH. 3) Improvement in eGFR of >= 30% compared to baseline. Participants must meet each TMA criterion at 2 separate assessments obtained at least 24 hours apart, and any measurement in between. Participants who did not have a response were censored at the date of last visit or study discontinuation at the time when the analysis was performed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Tucson | Arizona | 85724 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37094330 | Derived | Werion A, Storms P, Zizi Y, Beguin C, Bernards J, Cambier JF, Dahan K, Dierickx D, Godefroid N, Hilbert P, Lambert C, Levtchenko E, Meyskens T, Poire X, van den Heuvel L, Claes KJ, Morelle J; UCLouvain TMA/HUS Network and KU Leuven TMA/HUS Network. Epidemiology, Outcomes, and Complement Gene Variants in Secondary Thrombotic Microangiopathies. Clin J Am Soc Nephrol. 2023 Jul 1;18(7):881-891. doi: 10.2215/CJN.0000000000000182. Epub 2023 Apr 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ravulizumab | Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Treatment 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. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 10, 2021 | Nov 21, 2023 |
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|
| Placebo | Other | Matching placebo |
|
| Best Supportive Care | Other | Participants will receive medications, therapies, and interventions per standard hospital treatment protocols (unless specifically prohibited by the protocol). |
|
| Baseline through Week 26 |
| Number of Participants With Hematologic Response at Week 26 | Hematologic response required the following: (1) Normalization of platelet count without transfusion support during the prior 7 days, and (2) normalization of LDH. | Week 26 |
| Number of Participants With Renal Response at Week 26 | Renal response is improvement in eGFR of >= 30% compared to baseline. If a participant is on dialysis ≤5 days prior to the date of eGFR assessment, the eGFR will be set to 10 milliliter/minute/1.73 meter square (mL/min/1.73 m^2) for that assessment. If a participant is on dialysis during the entire 26 week randomized Treatment Period, or through early discontinuation of study drug, then the change in eGFR was not calculated. | Week 26 |
| Number of Participants On Dialysis at Week 26 | Week 26 |
| Change From Baseline in eGFR at Week 26 | If a participant is on dialysis during the entire 26 week randomized Treatment Period, or through early discontinuation of study drug, then the change in eGFR was not calculated. | Baseline, Week 26 |
| Orange |
| California |
| 92868 |
| United States |
| Research Site | Washington D.C. | District of Columbia | 20007 | United States |
| Research Site | Gainesville | Florida | 32610 | United States |
| Research Site | Lexington | Kentucky | 40536 | United States |
| Research Site | Louisville | Kentucky | 40202 | United States |
| Research Site | Boston | Massachusetts | 02111 | United States |
| Research Site | Boston | Massachusetts | 02115 | United States |
| Research Site | Boston | Massachusetts | 02118 | United States |
| Research Site | Rochester | Minnesota | 55905 | United States |
| Research Site | New York | New York | 10032 | United States |
| Research Site | Valhalla | New York | 10595 | United States |
| Research Site | Winston-Salem | North Carolina | 27103 | United States |
| Research Site | Cleveland | Ohio | 44106 | United States |
| Research Site | Cleveland | Ohio | 44195 | United States |
| Research Site | Columbus | Ohio | 43203 | United States |
| Research Site | Philadelphia | Pennsylvania | 19107 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15212 | United States |
| Research Site | Salt Lake City | Utah | 84115 | United States |
| Research Site | Morgantown | West Virginia | 26505 | United States |
| Research Site | Belgium | 1200 | Belgium |
| Research Site | Brussels | 1070 | Belgium |
| Research Site | Edegem | 2650 | Belgium |
| Research Site | Leuven | 3000 | Belgium |
| Research Site | Liège | 4000 | Belgium |
| Research Site | Belo Horizonte | 30150-221 | Brazil |
| Research Site | Botucatu | 18618-687 | Brazil |
| Research Site | Campinas | 13083-894 | Brazil |
| Research Site | Fortaleza | 60430-375 | Brazil |
| Research Site | Porto Alegre | 90110-270 | Brazil |
| Research Site | Ribeirão Preto | 14051-040 | Brazil |
| Research Site | Salvador | 41253-190 | Brazil |
| Research Site | São Paulo | 04036-002 | Brazil |
| Research Site | São Paulo | 05403-000 | Brazil |
| Research Site | Kingston | Ontario | K7L 3N6 | Canada |
| Research Site | Toronto | Ontario | M5B 1W8 | Canada |
| Research Site | Montreal | Quebec | H2X 3E4 | Canada |
| Research Site | Québec | Quebec | G1R 3S1 | Canada |
| Research Site | Bordeaux | 33076 | France |
| Research Site | Chambéry | 73011 | France |
| Research Site | Lille | 59037 | France |
| Research Site | Montpellier | France |
| Research Site | Paris | 75020 | France |
| Research Site | Paris | 75571 | France |
| Research Site | Tours | 37044 | France |
| Research Site | Essen | 45147 | Germany |
| Research Site | Hanover | 30625 | Germany |
| Research Site | Bergamo | 24127 | Italy |
| Research Site | Roma | 00168 | Italy |
| Research Site | Bunkyō City | 113-8431 | Japan |
| Research Site | Iruma-Gun | 350-0495 | Japan |
| Research Site | Mitaka-shi | 181-8611 | Japan |
| Research Site | Miyazaki | 889-1692 | Japan |
| Research Site | Nagoya | 466-8560 | Japan |
| Research Site | Nagoya | 466-8650 | Japan |
| Research Site | Osaka | 565-0871 | Japan |
| Research Site | Sapporo | 060-8648 | Japan |
| Research Site | Sendai | 980-8574 | Japan |
| Research Site | Shinjuku-ku | 162-8666 | Japan |
| Research Site | Amsterdam | 1100 DD | Netherlands |
| Research Site | Groningen | 9713 GZ | Netherlands |
| Research Site | Maastricht | 6229 HX | Netherlands |
| Research Site | Nijmegen | 6500 HB | Netherlands |
| Research Site | Daegu | 42415 | South Korea |
| Research Site | Gwangju | 61469 | South Korea |
| Research Site | Seoul | 02841 | South Korea |
| Research Site | Seoul | 03080 | South Korea |
| Research Site | Seoul | 04401 | South Korea |
| Research Site | Seoul | 06973 | South Korea |
| Research Site | Seoul | 134-727 | South Korea |
| Research Site | Seoul | 6591 | South Korea |
| Research Site | Barcelona | 08036 | Spain |
| Research Site | Granada | 18014 | Spain |
| Research Site | Las Palmas de Gran Canaria | 35016 | Spain |
| Research Site | Madrid | 28040 | Spain |
| Research Site | Kaohsiung City | 81362 | Taiwan |
| Research Site | Kaohsiung City | 833401 | Taiwan |
| Research Site | New Taipei City | 23561 | Taiwan |
| Research Site | Taichung | 40447 | Taiwan |
| Research Site | Taichung | 40705 | Taiwan |
| Research Site | Taipei | 11217 | Taiwan |
| Research Site | Bristol | BS10 5NB | United Kingdom |
| Research Site | Carshalton | SM5 1AA | United Kingdom |
| Research Site | Exeter | EX2 5DW | United Kingdom |
| Research Site | Leicester | LE3 9QP | United Kingdom |
| Research Site | Liverpool | L7 8XP | United Kingdom |
| Research Site | London | NW1 2BH | United Kingdom |
| Research Site | London | NW3 2QG | United Kingdom |
| Research Site | London | SE1 9RT | United Kingdom |
| Research Site | London | SE5 9RS | United Kingdom |
| Research Site | London | SW17 0QT | United Kingdom |
| Research Site | Manchester | M13 9WL | United Kingdom |
| Research Site | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Research Site | Nottingham | NG5 1PB | United Kingdom |
| Research Site | Oxford | OX3 9DU | United Kingdom |
| Research Site | Salford | M6 8HD | United Kingdom |
| Research Site | Stevenage | SG1 4AB | United Kingdom |
Participants received weight-based dosages of placebo matched to ravulizumab for 26 weeks during the Initial Treatment Period. Participants received a loading dose of placebo matched to ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter. |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Modified Intent-to-Treat Analysis Set included all randomized participants, excluding participants who enrolled prior to availability of ST-HUS and ADAMTS13 central laboratory results and were subsequently found to be ineligible after randomization.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ravulizumab | Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Treatment 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. |
| BG001 | Placebo | Participants received weight-based dosages of placebo matched to ravulizumab for 26 weeks during the Initial Treatment Period. Participants received a loading dose of placebo matched to ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter. |
| 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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 | Number of Participants With Complete Thrombotic Microangiopathy (TMA) Response at Week 26 | TMA response required the following: 1) Normalization of platelet count without transfusion support during the prior 7 days. 2) Normalization of LDH. 3) Improvement in glomerular filtration rate (eGFR) of >= 30% compared to baseline. Participants must meet each TMA criterion at 2 separate assessments obtained at least 24 hours apart, and any measurement in between. | The Modified Intent-to-Treat Analysis Set included all randomized participants, excluding participants who enrolled prior to availability of ST-HUS and ADAMTS13 central laboratory results and were subsequently found to be ineligible after randomization. | Posted | Count of Participants | Participants | Week 26 |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Complete TMA Response | The Kaplan-Meier estimate of time to event of complete TMA response is reported. TMA response required the following: 1) Normalization of platelet count without transfusion support during the prior 7 days. 2) Normalization of LDH. 3) Improvement in eGFR of >= 30% compared to baseline. Participants must meet each TMA criterion at 2 separate assessments obtained at least 24 hours apart, and any measurement in between. Participants who 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 Modified Intent-to-Treat Analysis Set included all randomized participants, excluding participants who enrolled prior to availability of ST-HUS and ADAMTS13 central laboratory results and were subsequently found to be ineligible after randomization. | Posted | Median | 95% Confidence Interval | days | Baseline through Week 26 |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Hematologic Response at Week 26 | Hematologic response required the following: (1) Normalization of platelet count without transfusion support during the prior 7 days, and (2) normalization of LDH. | The Modified Intent-to-Treat Analysis Set included all randomized participants, excluding participants who enrolled prior to availability of ST-HUS and ADAMTS13 central laboratory results and were subsequently found to be ineligible after randomization. | Posted | Count of Participants | Participants | Week 26 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Renal Response at Week 26 | Renal response is improvement in eGFR of >= 30% compared to baseline. If a participant is on dialysis ≤5 days prior to the date of eGFR assessment, the eGFR will be set to 10 milliliter/minute/1.73 meter square (mL/min/1.73 m^2) for that assessment. If a participant is on dialysis during the entire 26 week randomized Treatment Period, or through early discontinuation of study drug, then the change in eGFR was not calculated. | The Modified Intent-to-Treat Analysis Set included all randomized participants, excluding participants who enrolled prior to availability of ST-HUS and ADAMTS13 central laboratory results and were subsequently found to be ineligible after randomization. | Posted | Count of Participants | Participants | Week 26 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants On Dialysis at Week 26 | The Modified Intent-to-Treat Analysis Set included all randomized participants, excluding participants who enrolled prior to availability of ST-HUS and ADAMTS13 central laboratory results and were subsequently found to be ineligible after randomization. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Week 26 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in eGFR at Week 26 | If a participant is on dialysis during the entire 26 week randomized Treatment Period, or through early discontinuation of study drug, then the change in eGFR was not calculated. | The Modified Intent-to-Treat Analysis Set included all randomized participants, excluding participants who enrolled prior to availability of ST-HUS and ADAMTS13 central laboratory results and were subsequently found to be ineligible after randomization. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | milliliter/minute/1.73 meter^2 | Baseline, Week 26 |
|
Baseline up to Week 34
The Safety Analysis Set included all participants who received at least 1 dose of study intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ravulizumab | Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Treatment 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. | 3 | 9 | 6 | 9 | 9 | 9 |
| EG001 | Placebo | Participants received weight-based dosages of placebo matched to ravulizumab for 26 weeks during the Initial Treatment Period. Participants received a loading dose of placebo matched to ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter. | 0 | 7 | 3 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 pneumonia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Epstein-Barr viraemia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Renal pseudoaneurysm | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Shunt thrombosis | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Toxic epidermal necrolysis | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Corynebacterium infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Steroid diabetes | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Device related thrombosis | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Extravasation | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Illness | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Joint instability | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| SLE arthritis | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Substance dependence | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Bicytopenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pruritus allergic | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cardiac contractility decreased | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Left ventricular hypertrophy | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Ventricular hypokinesia | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Drain site complication | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Euthyroid sick syndrome | Endocrine disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Penile dermatitis | Reproductive system and breast disorders | MedDRA (25.1) | Systematic Assessment |
|
Due to continued enrollment challenges, Alexion decided to terminate this study prematurely. There were no safety or efficacy concerns throughout the course of study. The planned interim analysis for sample size re-estimation and the planned primary analysis as specified in Protocol Amendment 2 were not conducted due to early termination of the study. No hypothesis testing or inferential statistical analysis for the purpose of treatment comparisons was performed due to small sample size.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexion Pharmaceuticals, Inc. | Alexion Pharmaceuticals, Inc. | 855-752-2356 | clinicaltrials@alexion.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 13, 2022 | Nov 21, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D057049 | Thrombotic Microangiopathies |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000629409 | ravulizumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Participants |
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|