Clinical Trial Search

Primary: Change in Serum Inorganic Phosphorus at the End of Treatment From Baseline — -0.26; -0.20 mg/dL

Primary: Decrease in GFR During Treatment Period — -0.45 ml/min/1.73 m2 — p=<0.01

Primary: Change From Baseline in Prebronchodilator Clinic-Measured, Percent-Predicted Forced Expiratory Volume in 1 Second — 2.44; 0.48; 3.22; 2.59 Percent predicted — p=0.802

Primary: Number of Responders to American College of Rheumatology 20% Improvement Criteria (ACR 20) at Day 180 of the Double-Blind (DB) Period — 70; 44; 42 Participants — p=<0.001

Primary: Pathologic Assessment After Study Treatment — 18; 16; 30 participants

Primary: Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score at 5 Weeks — -2.08; -2.22; -2.45; -2.42 units on a scale

Primary: Change in 24-hour Urinary Supersaturation for Calcium Oxalate — 1.40; 1.36; 1.42 KJoules/mol — p=0.3

Primary: Percent Heavy Drinking Days — 37.1; 37.9 percentage of heavy drinking days

Primary: Mean Change in Hemoglobin Between Baseline and the Evaluation Period — 9.34; 9.20; 9.07; 11.45 g/dL

Primary: Number of Participants With a Partial Response — 2; 0 Participants

Primary: Haemagglutination Inhibition (HI) Antibody Titers — 82.3; 102.2; 98.2; 91.7 titer

Primary: Maximum Observed Concentration (Cmax) for Ingenol Mebutate and Its Two Acyl Isomers (PEP015 and PEP025) Levels — NA; NA ng/mL

Primary: The Proportion of Patients Who Develop Full Donor T Cell Chimerism at Day 30 — 44.9 percentage of participants

Primary: Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains — 6.0; 6.0; 86.5; 93.1 Titer

Primary: Mean Hemoglobin Throughout the Trial and Mean Hemoglobin Change From Baseline Throughout the Trial. — 11.10; 11.34; 11.42; 11.19 g/dL