A Phase 3 interventional study of Ravulizumab in Atypical Hemolytic Uremic Syndrome (aHUS), sponsored by Alexion Pharmaceuticals, Inc.. Completed at 18 sites in 7 countries. Per ClinicalTrials.gov, last updated 2024-03-15.
Sponsored by Alexion Pharmaceuticals, Inc. (part of AstraZeneca) · Phase 3, Interventional, and Treatment
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Among 19 studies in Atypical Hemolytic Uremic Syndrome by AstraZeneca — 4 open to participants now, 5 under way, none of them phase 3. Atypical Hemolytic Uremic Syndrome · AstraZeneca.
Among the 19 studies in Atypical Hemolytic Uremic Syndrome by AstraZeneca, this one is the 3rd largest by enrollment of the 10 interventional ones that give a count, is one of 2 that started in 2017, is one of 2 in phase 3, and was the 14th registered.
45 studies on the registry are indexed under Atypical Hemolytic Uremic Syndrome; 14 are open to participants now.
Browse Atypical Hemolytic Uremic Syndrome studies →4 of the 19 studies in Atypical Hemolytic Uremic Syndrome by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in Poland
Ages 18+
Alexion Pharmaceuticals, Inc. · Sites in Japan
Ages 18+
Alexion Pharmaceuticals, Inc. · Sites in United States, Australia, France and 4 more countries
Women only
Alexion Pharmaceuticals, Inc. · Sites in United States, Australia, Belgium and 14 more countries
By country, each count listing its studies:
Of the 12 Atypical Hemolytic Uremic Syndrome studies recruiting now, 10 (83%) set no upper age limit and none (0%) stop at 75 or younger; 6 take children under 18; 2 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
19 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 2 started in 2017.
This study's enrollment of 34 is close to the median of 34 across 26 interventional studies indexed under Atypical Hemolytic Uremic Syndrome.
Median enrollment 18 across the 10 interventional studies, 80 across the 9 observational. Of the 14 that completed or were terminated, 9 (64%) have results posted.
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This study is registered under Alexion Pharmaceuticals, Inc., one of the names counted as AstraZeneca. Under that name alone:
Alexion Pharmaceuticals, Inc. is the lead sponsor of 255 studies on the registry; 23 are open to participants now.
Of its 101 completed or terminated interventional studies of FDA-regulated products, 75 (74%) have results posted.
1 of the studies in Atypical Hemolytic Uremic Syndrome by AstraZeneca that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07308574Alexion Pharmaceuticals, Inc.Post-Marketing Clinical Study of Ravulizumab in Participants With Clinical aHUS | 2027-06-25 |
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Among the 19 studies in Atypical Hemolytic Uremic Syndrome by AstraZeneca, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of the study is to assess the efficacy of ravulizumab to control disease activity in children and adolescents with aHUS who have not previously used a complement inhibitor (complement inhibitor treatment-naïve), as well as in complement inhibitor-experienced (eculizumab-experienced) adolescent participants.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Complement Inhibitor Treatment Naïve:
Eculizumab Experienced:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants were administered weight-based doses of ravulizumab every 8 weeks thereafter for participants weighing ≥ 20 kg, or once every 4 weeks for participant weighing \< 20 kg, for a total of 26 weeks of study treatment in the initial Evaluation Period. After the Initial Evaluation Period, participants rolled over into an Extension Period in which all participant continued their weight-based maintenance dose until the product was registered or approved (in accordance with country specific regulation) or for up to 4.5 years, whichever occurred first.
Biological: Ravulizumab
Participant received weight-based dosages for 26 weeks during the Initial Evaluation Period. Participants received a loading dose on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter for participants weighing ≥ 20 kg, or once every 4 weeks for participant weighing \< 20 kg.
Also known as: ALXN1210, Ultomiris
Percentage Of Complement Inhibitor Treatment-naïve Participants With Complete Thrombotic Microangiopathy (TMA) Response at Week 26
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. Percentage based on the responders among treated participants. Confidence interval (CI) based on exact confidence limits using the Clopper Pearson method.
Time frame: Week 26
Time To Complete TMA Response In Complement Inhibitor Treatment-naïve Participants
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. Participants had to meet all complete TMA response criteria at 2 separate assessments obtained at least 4 weeks (28 days) apart, and any measurement in between.
Time frame: Baseline through at least Week 52 and up to Week 111
Proportion Of Complement Inhibitor Treatment-naïve Participants With Complete TMA Response At Week 52
The proportion of participants considered responders, along with a 2-sided 95% CI based on exact confidence limits using the Clopper Pearson method is reported.
Time frame: Week 52
Participants Who Do Not Require Dialysis at Weeks 26 and 52
For participants requiring dialysis within 5 days prior to ALXN1210 treatment initiation, the number of participants no longer requiring dialysis is reported.
Time frame: Week 26 and Week 52
Change From Baseline In eGFR At Weeks 26 and 52
Kidney function evaluated by eGFR was summarized at baseline and the Week 26 and Week 52 time points 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 mL/min/1.73 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 and Week 52
Participants With Change From Baseline In CKD Stage At Weeks 26 and 52
The CKD stage is presented as the change from baseline in the 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, and Week 52
Change From Baseline In Platelet Count At Weeks 26 and 52
The hematologic TMA parameter of platelet count was summarized at baseline and at Week 26 and Week 52 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 and Week 52
Change From Baseline In LDH At Weeks 26 and 52
The hematologic TMA parameter of serum LDH was summarized at baseline and at Week 26 and Week 52 using descriptive statistics for continuous variables for the change from baseline. Results are reported in units (U)/L serum.
Time frame: Baseline, Week 26 and Week 52
Change From Baseline In Hemoglobin At Weeks 26 and 52
The hematologic TMA parameter of hemoglobin level was summarized at baseline and at Week 26 and Week 52 using descriptive statistics for continuous variables for the change from baseline. Results are reported in grams (g)/L blood.
Time frame: Baseline, Week 26 and Week 52
Percentage Of Complement Inhibitor Treatment-naïve Participants With An Increase From Baseline In Hemoglobin ≥20 g/L Through Week 26 and Week 52
The percentage 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 Week 52 and is presented as the percentage of responders, along with a 2-sided 95% CI. The 95% CIs are based on exact confidence limits using the Clopper-Pearson method. To be considered a responder during the 26-week and 52-week Extension Periods, the latest time point a participant could first meet the response criteria was 28 days before the respective Week 26 and Week 52 assessments (components of the response maintained for at least 28 days).
Time frame: Baseline through Week 26 and through Week 52
Change From Baseline In Quality Of Life As Measured By The Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Version 4 Questionnaire (Participants ≥5 Years Of Age) At Weeks 26 and 52
Quality of life was assessed in participants \>5 years of age by the Pediatric FACIT-Fatigue Questionnaire (reported by participants who were ≥8 years of age at the time of enrollment; caregiver reported or caregiver assistance for participants who were 5 to \<8 years of age at the time of enrollment). The FACIT Fatigue data were summarized at baseline and each post baseline time point using descriptive statistics for continuous variables for the observed value as well as the change from baseline. The FACIT Fatigue Version 4 questionnaire at baseline and each post-infusion time point was scored using standard scoring algorithms. The score ranges from 0 to 52, with a higher score indicating less fatigue. An increase in score indicated an improvement in quality of life.
Time frame: Baseline, Week 26 and Week 52
| Milestone | Complement Inhibitor Treatment Naïve | Eculizumab Experienced |
|---|---|---|
| Started | 24 | 10 |
| Received at least 1 dose of study drug | 24 | 10 |
| Completed | 17 | 10 |
| Not completed | 7 | 0 |
| Withdrew: Adverse event | 2 | 0 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Deemed ineligible post treatment | 3 | 0 |
| Withdrew: Physician decision | 1 | 0 |
| Milestone | Complement Inhibitor Treatment Naïve | Eculizumab Experienced |
|---|---|---|
| Started | 17 | 10 |
| Received at least 1 dose of study drug | 17 | 10 |
| Completed | 16 | 10 |
| Not completed | 1 | 0 |
| Withdrew: Physician decision | 1 | 0 |
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. Percentage based on the responders among treated participants. Confidence interval (CI) based on exact confidence limits using the Clopper Pearson method.
| percentage of participants | Complement Inhibitor Treatment Naïve |
|---|---|
| Complete TMA response | 77.8 (52.4 to 93.6) |
| Platelet count normalization | 94.4 (72.7 to 99.9) |
| LDH normalization | 88.9 (65.3 to 98.6) |
| ≥ 25% improvement in serum creatinine from baseline | 83.3 (58.6 to 96.4) |
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. Participants had to meet all complete TMA response criteria at 2 separate assessments obtained at least 4 weeks (28 days) apart, and any measurement in between.
| days | Complement Inhibitor Treatment Naïve |
|---|---|
| Time To Complete TMA Response In Complement Inhibitor Treatment-naïve Participants | 30.0 (22.0 to 88.0) |
The proportion of participants considered responders, along with a 2-sided 95% CI based on exact confidence limits using the Clopper Pearson method is reported.
| proportion of participants | Complement Inhibitor Treatment Naïve |
|---|---|
| Complete TMA responder | 0.882 (0.636 to 0.985) |
| Platelet count normalization | 0.882 (0.636 to 0.985) |
| LDH normalization | 1.000 (0.805 to 1.000) |
| ≥25% improvement in serum creatinine from baseline | 1.000 (0.805 to 1.000) |
For participants requiring dialysis within 5 days prior to ALXN1210 treatment initiation, the number of participants no longer requiring dialysis is reported.
| Participants | Complement Inhibitor Treatment Naïve | Eculizumab Experienced |
|---|---|---|
| Week 26 | 5 | 0 |
| Week 52 | 6 | 0 |
Kidney function evaluated by eGFR was summarized at baseline and the Week 26 and Week 52 time points 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 mL/min/1.73 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.
| mL/min/1.73 m^2 | Complement Inhibitor Treatment Naïve | Eculizumab Experienced |
|---|---|---|
| Baseline | 22.0 (10 to 84) | 99.75 (54 to 136.5) |
| Change From Baseline at Week 26 | 80.0 (0 to 222) | -2.00 (-94 to 18) |
| Change From Baseline at Week 52 | 94.0 (10 to 230) | -3.00 (-20 to 9) |
The CKD stage is presented as the change from baseline in the 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.
| Participants | Complement Inhibitor Treatment Naïve | Eculizumab Experienced |
|---|---|---|
| Week 26, Improved | 15 | 0 |
| Week 26, Worsened | 0 | 3 |
| Week 26, Stayed the Same | 2 | 7 |
| Week 52, Improved | 16 | 0 |
| Week 52, Worsened | 0 | 0 |
| Week 52, Stayed the Same | 0 | 10 |
The hematologic TMA parameter of platelet count was summarized at baseline and at Week 26 and Week 52 using descriptive statistics for continuous variables for the change from baseline. Results are reported in platelets\*10\^9/liter (L) blood.
| platelets*10^9/L | Complement Inhibitor Treatment Naïve | Eculizumab Experienced |
|---|---|---|
| Baseline | 51.25 (14 to 125) | 281.75 (207 to 415.5) |
| Change from Baseline at Week 26 | 247.00 (57.5 to 368.5) | -2.25 (-74.5 to 123.5) |
| Change from Baseline at Week 52 | 213.00 (19.5 to 471.5) | -34.75 (-109 to 109) |
The hematologic TMA parameter of serum LDH was summarized at baseline and at Week 26 and Week 52 using descriptive statistics for continuous variables for the change from baseline. Results are reported in units (U)/L serum.
| U/L | Complement Inhibitor Treatment Naïve | Eculizumab Experienced |
|---|---|---|
| Baseline | 1963.00 (772 to 4985) | 206.50 (138.5 to 356) |
| Change From Baseline at Week 26 | -1851.50 (-4713 to -513) | -8.50 (-50.5 to 50.5) |
| Change From Baseline at Week 52 | -1825.50 (-4724 to -579) | -17.50 (-34.5 to 29.5) |
The hematologic TMA parameter of hemoglobin level was summarized at baseline and at Week 26 and Week 52 using descriptive statistics for continuous variables for the change from baseline. Results are reported in grams (g)/L blood.
| g/L | Complement Inhibitor Treatment Naïve | Eculizumab Experienced |
|---|---|---|
| Baseline | 74.25 (32 to 106) | 132.00 (114.5 to 148) |
| Change From Baseline at Week 26 | 46.50 (26.5 to 86) | -3.50 (-19.5 to 8) |
| Change From Baseline at Week 52 | 51.50 (-19 to 80) | 5.50 (-7.5 to 13.5) |
The percentage 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 Week 52 and is presented as the percentage of responders, along with a 2-sided 95% CI. The 95% CIs are based on exact confidence limits using the Clopper-Pearson method. To be considered a responder during the 26-week and 52-week Extension Periods, the latest time point a participant could first meet the response criteria was 28 days before the respective Week 26 and Week 52 assessments (components of the response maintained for at least 28 days).
| percentage of participants | Complement Inhibitor Treatment Naïve |
|---|---|
| Week 26 | 100 (80.5 to 100) |
| Week 52 | 94.1 (71.3 to 99.9) |
Quality of life was assessed in participants \>5 years of age by the Pediatric FACIT-Fatigue Questionnaire (reported by participants who were ≥8 years of age at the time of enrollment; caregiver reported or caregiver assistance for participants who were 5 to \<8 years of age at the time of enrollment). The FACIT Fatigue data were summarized at baseline and each post baseline time point using descriptive statistics for continuous variables for the observed value as well as the change from baseline. The FACIT Fatigue Version 4 questionnaire at baseline and each post-infusion time point was scored using standard scoring algorithms. The score ranges from 0 to 52, with a higher score indicating less fatigue. An increase in score indicated an improvement in quality of life.
| units on a scale | Complement Inhibitor Treatment Naïve | Eculizumab Experienced |
|---|---|---|
| Baseline | 35.00 (4 to 44) | 50.00 (42 to 52) |
| Change From Baseline at Week 26 | 10.00 (4 to 48) | 0.00 (-5 to 3) |
| Change From Baseline at Week 52 | 9.00 (3 to 47) | -1.00 (-7 to 2) |
Collected over From the beginning of the initial evaluation period (Day 1) through data cutoff (at least 52 weeks and up to a maximum of 111 weeks of treatment, representing 36.2 patient-years of exposure).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Complement Inhibitor Treatment Naïve | 0/24 (0%) | 16/24 (66.7%) | 21/24 (87.5%) |
| Eculizumab Experienced | 0/10 (0%) | 1/10 (10%) | 10/10 (100%) |
| Event | Complement Inhibitor Treatment Naïve | Eculizumab Experienced |
|---|---|---|
| PyrexiaGeneral disorders | 4/24 | 0/10 |
| DiarrhoeaGastrointestinal disorders | 3/24 | 0/10 |
| BronchitisInfections and infestations | 1/24 | 1/10 |
| PneumoniaInfections and infestations | 1/24 | 1/10 |
| Upper respiratory tract infectionInfections and infestations | 1/24 | 1/10 |
| Gastroenteritis viralInfections and infestations | 2/24 | 0/10 |
| Abdominal painGastrointestinal disorders | 2/24 | 0/10 |
| Cytomegalovirus enteritisInfections and infestations | 1/24 | 0/10 |
| Escherichia bacteraemiaInfections and infestations | 1/24 | 0/10 |
| Escherichia pyelonephritisInfections and infestations | 1/24 | 0/10 |
| Event | Complement Inhibitor Treatment Naïve | Eculizumab Experienced |
|---|---|---|
| PyrexiaGeneral disorders | 10/24 | 0/10 |
| Upper respiratory tract infectionInfections and infestations | 3/24 | 4/10 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 0/24 | 3/10 |
| NasopharyngitisInfections and infestations | 7/24 | 2/10 |
| VomitingGastrointestinal disorders | 7/24 | 1/10 |
| HeadacheNervous system disorders | 7/24 | 1/10 |
| DiarrhoeaGastrointestinal disorders | 6/24 | 1/10 |
| HypertensionVascular disorders | 6/24 | 1/10 |
| Abdominal painGastrointestinal disorders | 5/24 | 1/10 |
| CoughRespiratory, thoracic and mediastinal disorders | 5/24 | 1/10 |
Safety: All participants who received at least 1 dose of study drug.
| Age, Continuous(years) | Complement Inhibitor Treatment Naïve | Eculizumab Experienced | Total |
|---|---|---|---|
| Mean | 6.0 ± 4.79 | 11.0 ± 4.97 | 8.1 ± 5.17 |
| Sex: Female, Male(Participants) | Complement Inhibitor Treatment Naïve | Eculizumab Experienced | Total |
|---|---|---|---|
| Female | 14 | 1 | 15 |
| Male | 10 | 9 | 19 |
| Ethnicity (NIH/OMB)(Participants) | Complement Inhibitor Treatment Naïve | Eculizumab Experienced | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 3 |
| Not Hispanic or Latino | 22 | 9 | 31 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Baseline Estimated Glomerular Filtration Rate (eGFR)(mL/min/1.73 m^2) | Complement Inhibitor Treatment Naïve | Eculizumab Experienced | Total |
|---|---|---|---|
| Mean | 26.4 ± 21.17 | 104.90 ± 29.545 | NA ± NA |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Aug 2017 to primary completion in Dec 2022, 63 months.
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Studies of the drug tested here: Ravulizumab
Atypical Hemolytic Uremic Syndrome →
Alexion Pharmaceuticals, Inc. →