Clinical Trial Search

Primary: Change From Baseline in Lactate Dehydrogenase — 1845.1; 398.7; -1446.4 Units/Liter — p=<0.0001

Primary: Percentage Change From Baseline in LDH at Week 12 — -76.5 percentage change — p=<0.001

Primary: Measurement of Ratio of LDH to the Upper Limit of Normal (ULN) — 5.6; 1.9 Ratio of LDH:ULN (250 U/L)

Primary: Change From Baseline in LDH Level at Week 25 — -683.29 U/L

Primary: Percentage of Participants With Reduction in Serum Lactate Dehydrogenase (LDH) Levels Within the First 4 Weeks of LFG316 Treatment as Measured by Response Rate — 10; 0…

Primary: Maximum Observed Serum Concentration (Cmax) Of Ravulizumab — 725.40; 884.63; 1161.60; 1612.50 μg/mL

Primary: Incidence of Treatment-emergent Adverse Events — 182 Participants

Primary: Percentage of Participants Who Experienced Free C5-associated BTH — 0 percentage of participants

Primary: Least Squares (LS) Mean Change From Baseline to Week 16 in Hemoglobin (Hb) Level During the RCP — 2.37; -1.47 Grams per deciliter (g/dL) — p=<0.0001

Primary: Percentage of Participants Who Achieved Adequate Control of Intravascular Hemolysis — 75.0 Percentage of Participants

Primary: LDH Level at Week 27 (Parallel Comparison) — 205.69; 193.53 U/L

Primary: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) — 66.7; 41.7; 16.7; 0 Percentage of participants

Primary: Measurement of Serum Lactate Dehydrogenase (LDH) — 2913; 3056; 1453; 564 U/L

Primary: Difference in NRS Pain Score Between Baseline and 12 Hours — -0.2; -0.2 score on a scale

Primary: Change From Baseline in Lactate Dehydrogenase — -15.9 Units/Liter — p=<0.001

Primary: Peak And Trough Concentrations Of Eculizumab In Serum At Week 12 — 192.5; 425.4 μg/mL

Primary: Number of Subjects Who Achieved Hemoglobin (Hb) Stabilization — 30; 0 Participants — p=<0.0001

Primary: Remission — 6.1; 6.9 months

Primary: Summary of Lactate Dehydrogenase (LDH) Responders — 6; 5; 7; 5 Participants

Primary: Percent Change In LDH Levels From Baseline To Day 253 And Day 281 — -72.85; -78.12; -84.96; -87.63 Percent Change — p=<0.0001

Primary: OLTP: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 6 Participants

Primary: Number of Participants Who Experienced an Adverse Event (All Types/Grades) Within a Time Frame up to 24 Hours Following the Transfusion. — 2; 3 Participants

Primary: F2-isoprostanes After 72 Hours of Acetaminophen or Placebo — 33.4; 40.15 pg/mL — p=0.353

Primary: Safety and Tolerability Will be Measured by Acute NiCord® Infusional Toxicity. — 0; 0; 3; 0 participants

Primary: Mean Percent Conversion of Hydroxyproline (Hyp) to Urinary Oxalate (UOx) — 12.8; 32.9; 14.8 percent converted

Primary: Percent Change From Baseline in Lactate Dehydrogenase (LDH) Level at Day 92 — -53.59; -25.56; -43.58 Percent change from Baseline

Primary: Change From Baseline In Hemoglobin At Week 24 — 7.94; 10.33; 2.39 g/dL

Primary: Ctrough Serum Concentration of Ravulizumab — 457.58; 578.70 micrograms/milliliter (µg/mL) — p=<0.0001

Primary: Lactate Dehydrogenase (U/L) at Week 26 — 284.20; 249.72 U/L

Primary: % of Red Blood Cells With Hemolysis — 0.29; 0.29 % of Red Blood Cells with Hemolysis