Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02152228 | A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism | PHASE2 | COMPLETED | 20 | — | — | Jul 1, 2014 | Jul 1, 2015 | Oct 7, 2015 | 1 | Israel |
safety will be measured by monitoring and recording adverse events related to hyper- and hypocalcemia
To study the pharmacokinetic profile of PTH absorption
| Arm | Type | Description |
|---|---|---|
| Oral Parathyroid Hormone (1-34) | EXPERIMENTAL | Oral administration of EnteraBio's Oral Parathyroid Hormone (1-34) |
| Name | Type | Description |
|---|---|---|
| EnteraBio's Oral Parathyroid Hormone (1-34) | DRUG | Oral administration |
Inclusion Criteria: * Confirmed diagnosis of primary hypoparathyroidism for more than 1 year. * Currently taking \>1.0 grams of Calcium/day with a correlate alpha D3 dose. * 25(OH)D levels ≥ 20 ng/ml. * Signed informed consent. * BMI 18 - 30 kg/m2, inclusive. * Full blood count should be within the...