Clinical Trial Search

Primary: Number of Participants Who Achieved Clinical Cure at Test of Cure (TOC) Visit (Within 24 to 72 Hours From the Time of Last Dose): Per-Protocol (PP) Population — 90; 93…

Primary: Part A: Maximum Observed Concentration (Cmax) of TEZ and IVA — 6630; 4310; 6300; 5340 nanogram per milliliter (ng/mL)

Primary: Number of Participants Who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index ≥4 (SRI[4]) at Week 52 (Original Analysis With Restricted Medication Rules)…

Primary: Right (PSV R) and Left (PSV L) Cavernosal Artery Mean PSV Before Treatment — 34.52; 30.85; 34.33; 31.73 cm/sec

Primary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the Food and Drug Administration (FDA)-Defined Snapshot Algorithm — 97.7 percentage of…

Primary: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 52 — 0.4; 0.5; 1.7 Scores on a scale — p=<0.0001

Primary: Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall — 14.6; 13.8; 15.1; 14.6 Percentage of…

Primary: Total Annualized Bleeding Rate (TABR) — 2.10 No. of BEs / year (ABR) — p=<0.0001

Primary: Annualized Total Bleeding Rate of Individually Tailored Prophylaxis — 4.67; 58.08 Bleeding events per year (ABR) — p=<0.0001

Primary: Aberrant Behavior Checklist (ABC) - Parent Reported Change — -2.4 score on a scale — p=0.56

Primary: Headache Recurrence at 48 Hours — 1; 1 Participants

Primary: Visual Ability (VA) — 0.91; 0.87 units on a scale (LogMAR) — p=0.065

Primary: Positive Predictive Value (PPV) on a Per-patient Basis With Histologic Validation — 0.90 percentage of times value is true

Primary: Objective Response Rate (ORR) — 109; 37 Count of Participants — p=0.002

Primary: Weeks of Abstinence From Cocaine — 1.0; 1.0 weeks