Phase 3 N=57 C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study)
Hereditary Angioedema
Primary: Time to Start of Relief of Symptoms From HAE Attack (Intent to Treat (ITT) Subject Population) — 0.46 hours
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=32 Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Hereditary Angioedema · Angioneurotic Edema · Genetic Disorders
Primary: Time to Beginning of Relief of Symptoms — 62; 508; 61 minutes — p=0.003
Phase 3 N=126 Human C1 Esterase Inhibitor (C1-INH) in Subjects With Acute Abdominal or Facial Hereditary Angioedema (HAE) Attacks
Hereditary Angioedema
Primary: Time to Start of Relief of Symptoms From HAE Attack — 1.17; 0.5; 1.5 Hours — p=0.0025
Phase 3 N=38 Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Hereditary Angioedema · Angioneurotic Edema
Primary: Time to Beginning of Relief of Symptoms — 68; 122; 258; 62.5 minutes — p=0.001
Phase 2 N=25 A Study of the Safety and Immunogenicity of Repeated rhC1INH Administration
Genetic Disorders · Hereditary Angioedema
Primary: HAE Attacks/Week — 0.9; 0.4 attacks/week
Phase 3 N=387 A Long Term Safety Study of BCX7353 in Hereditary Angioedema
Hereditary Angioedema · HAE · Prophylaxis
Primary: Safety & Tolerability — 94; 240; 58; 119 Participants
Phase 2 N=75 Efficacy and Safety of BCX7353 to Prevent Angioedema Attacks in Subjects With Hereditary Angioedema
Hereditary Angioedema (HAE)
Primary: Number of Confirmed HAE Attacks — 0.519; 0.527; 0.249; 0.852 HAE attacks per week — p=<0.001
Phase 3 N=64 CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks
Hereditary Angioedema
Primary: Time-Normalized Number of Hereditary Angioedema (HAE) Attacks Per Month During Treatment Period — 0.27; 2.01 number of HAE attacks per month — p=<0.001
Phase 4 N=10 Treatment of Idiopathic Angioedema With Xolair as Add-on Therapy
Idiopathic Angioedema
Primary: Mean 7-day Angioedema Activity Score (AAS7) — 2.8; 1.6; 0.69; 0.20 score on a scale
Phase 2 N=74 Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema
Hereditary Angioedema · Hereditary Angioedema Type I · Hereditary Angioedema Type II
Primary: Change of the 3-symptom Composite Visual Analogue Scale (VAS-3) Score From Pre-treatment to 4 Hours Post-treatment — -14.83; -13.10; -14.37; 1.92 Score on a scale — p=<…
Phase 2 N=44 A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE)
Hereditary Angioedema
Primary: The Mean Time Normalized Number of HAE Attacks Per Month in Subjects With C1-INH HAE During Treatment Period 1 — 4.24; 0.48; 0.05; 0.35 Number of HAE attacks per month
Phase 3 N=84 Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema
Angioedema
Primary: Time to Onset of Symptom Relief (TOSR) — 2.5; 4.6 Hours — p=0.142
Phase 2 N=58 Study of BCX7353 as a Treatment for Attacks of Hereditary Angioedema
Hereditary Angioedema (HAE)
Primary: Proportion of Subjects With Improved or Stable Composite Visual Analog Scale (VAS) Score — 13.96; 15.04; 10.54; 18.42 VAS score - millimeters — p=0.0024
Phase 3 N=83 C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks
Hereditary Angioedema
Primary: Time to Beginning of Substantial Relief of the Defining Symptom — 2.0; 4.0 hours — p=0.048
Phase 3 N=126 A Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema
Hereditary Angioedema Types I and II
Primary: Person-time Incidence Rates (Subject Based) — 0.01; 0.03; 0.00; 0.01 participants with events/year
Phase 3 N=110 A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)
Hereditary Angioedema
Primary: Time to Beginning of Symptom Relief Patient Global Impression of Change (PGI-C) — 1.61; 1.79; 6.72 Time (h) — p=<0.0001
Phase 3 N=110 12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks
Hereditary Angioedema · HAE
Primary: The Mean Acute Angioedema Attack Rate — 0.675; 0.589; 0.593 Confirmed attacks per week
Phase 3 N=75 Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1 Esterase Inhibitor for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema
Hereditary Angioedema (HAE)
Primary: Time-Normalized Number of Attacks (NNA) for Participants During a Treatment Period — 1.611; 3.931 Number of attacks — p=<0.0001
Phase 3 N=121 Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE
Hereditary Angioedema · HAE
Primary: Part 1: The Rate of Investigator-confirmed HAE Attacks During Dosing in the Entire 24-week Treatment Period (Day 1 to Day 168) — 1.65; 1.31; 2.35 HAE attack rate per 28…
Phase 2 N=68 A Phase II, Cross-over Clinical Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) in the On-demand Treatment of Angioedema Attacks in Adult Subjects With Hereditary Angioedema Type I or II
Hereditary Angioedema
Primary: Time to Conventional Attack Treatment Use Within 12 Hours of Study Drug (Full Analysis Set) — NA; NA Time (h) — p=0.0010
Phase 3 N=21 A Study of Lanadelumab to Prevent Hereditary Angioedema (HAE) Attacks in Children
Hereditary Angioedema
Primary: Number of Participants With Adverse Events Including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) — 0; 0; 0; 0 Participants
Phase 3 N=24 C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks
Hereditary Angioedema
Primary: Number of Hereditary Angioedema (HAE) Attacks During Each Prophylactic Therapy Period — 6.1; 12.7; 6.3; 12.7 attacks — p=<0.0001
Phase 3 N=98 A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3)
Hereditary Angioedema
Primary: Time to Onset of Symptom Relief for an Acute Attack, as Assessed by the Patient — 2.0; 19.8 Hours — p=<0.001
Phase 3 N=8 Study of C1 Inhibitor (Human) for the Prevention of Angioedema Attacks and Treatment of Breakthrough Attacks in Japanese Subjects With Hereditary Angioedema (HAE)
Hereditary Angioedema (HAE)
Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 7 Participants
Phase 3 N=75 Efficacy, Safety and Immunogenicity Study of Recombinant Human C1 Inhibitor for the Treatment of Acute HAE Attacks
Hereditary Angioedema
Primary: Time to Beginning of Relief of Symptoms — 90; 152 minutes
Phase 3 N=90 A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema
Hereditary Angioedema Types I and II
Primary: The Time-normalized Number of Hereditary Angioedema Attacks — 0.04; 0.02; 0.12; 0.13 attacks/day — p=< 0.001
Phase 2 N=32 A Phase 2 HAE Prophylaxis Study With Recombinant Human C1 Inhibitor
Hereditary Angioedema
Primary: Number of HAE Attacks — 2.74; 4.36; 7.18 attacks
Phase 3 N=32 A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema
Hereditary Angioedema (HAE)
Primary: Time to Peak Concentration (Tmax) of a Single Subcutaneous (SC) Dose of Icatibant — 0.42; 0.55; 0.57 Hour (h)
Phase 3 N=96 Efficacy Study of DX-88 (Ecallantide) to Treat Acute Attacks of Hereditary Angioedema (HAE)
Hereditary Angioedema (HAE)
Primary: Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose — 2.2; 2.0; 1.4; 1.6 units on a scale — p=0.010
Phase 3 N=72 Efficacy and Safety Study of DX-88 to Treat Acute Attacks of Hereditary Angioedema (HAE)
Hereditary Angioedema (HAE)
Primary: Treatment Outcome Score at 4 Hours Post-Dose — 49.5; 18.5 units on a scale — p=0.037