Clinical Trial Search

Primary: Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 6 — -0.005 Millimole per liter (mmol/L)

Primary: Serum Calcium Level — 2; 1.92 mmol/liter

Primary: The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 24. — 2.5; 54.8 percentage of participants — p=<0.001

Primary: Requirements for Calcium Supplementation — 3.03; 1.66 grams per day of calcium supplementation

Primary: Mean Serum Calcium in Children and Young Adults — 2.02; 1.88 mmol/liter — p=0.02

Primary: Change From Baseline in Hypoparathyroidism Symptom Diary (HypoPT-SD) Symptom Subscale Score at Week 26 — -0.93; -1.46 score on a scale — p==0.003

Primary: Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase — 15; 5 Participants — p=0.006

Primary: Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) — 13; 48 Participants

Primary: Change in Dose of Calcium Supplementation — 37 percent change in dose

Primary: Percentage of Participants With a Mean Corrected Total Serum Calcium Value < 10.2 mg/dL (2.55 mmol/L) During the Efficacy Assessment Phase (EAP) — 3.5; 78.9 percentage…

Primary: Percent Change in Fractional Excretion of Calcium (FECa) — -39 percentage of change

Primary: Treatment Emergent Adverse Events (TEAEs) — 2; 3; 5; 1 Participants

Primary: Change in Lumbar Spine Bone Mineral Density — 0.030; 0.042; -0.016 g/cm^2 — p=< 0.00001

Primary: Efficacy - Primary Endpoint During the Blinded Period — 50.0; 40.0; 60.0; 26.7 Percentage of participants — p== 0.2635

Primary: Modified City of Hope Quality of Life Questionnaire for Patients With Thyroid Disease — -36.33 score on a scale

Primary: The Level of Activated Vitamin D (1,25-dihydroxyvitamin D) After Parathyroid Hormone Infusion at Baseline, 4 and 8 Hours — 40.6; 46.2; 39.8; 58.8 pg/ml — p=0.1

Primary: Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data. — 21.1; 26.1 percentage of participants — p=>0.999

Primary: Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 24, Based on Investigator Prescribed Data. — 75.0 percentage of participants

Primary: Number of Participants With iPTH Levels Maintained at the Target Levels of 60-180 pg/mL iPTH Level — 10; 4; 2; 7 participants — p=0.036

Primary: The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels — 93; 57; 12; 45 participants

Primary: Type of Hyperparathyroidism — 90; 276; 19; 61 Participants

Primary: Participants With Dose Limiting Toxicity — 0; 2 participants

Primary: Serum Parathyroid Hormone (PTH) Level

Primary: Decrease in Preoperative P-PTH — -2.2; 0.2 pmol/l

Primary: Area Under the Curve for Parathyroid Hormone (PTHauc) Measurement — 1223; 1449; 987; 1616 nlEq*26hr/ml — p=0.007

Primary: Mean Erythropoietin Dose Per Visit — 35.8; 22.2; 22.7; 4.7 µg

Primary: Time of Maximum Observed Concentration (Cmax) During a Dosing Interval (Tmax) of Baseline Adjusted rhPTH(1-84) — 7.108; 7.083; 0.333; 1.000 hours

Primary: Efficacy - Primary Endpoint During the Blinded Period — 78.7; 4.8 Percentage of participants — p=<0.0001

Primary: Percent Reduction in PTH — 27; 10 % change in PTH baseline to 3 months

Primary: Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline — 5; 49…