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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03516773 | Oral PTH(1-34) PK and PD Study in Patients With Hypoparathyroidism | PHASE2 | COMPLETED | 20 | — | — | Jun 17, 2018 | Feb 24, 2019 | Mar 26, 2019 | 1 | Israel |
Pharmacokinetic Parameter
Pharmacodynamic Parameter
Pharmacodynamic Parameter
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | Intervention: EB612 (EBP05) 2.25 mg orally (PO) four times a day (QID) (approximately 5 hours apart) for 4 doses, for a total dose of 9 mg per day |
| Treatment B | EXPERIMENTAL | Intervention: EB612 (EBP05) 2.25 mg PO twice a day (BID) (approximately 10 hours apart) for 2 doses, for a total dose of 4.5 mg per day |
| Treatment C | ACTIVE_COMPARATOR | Intervention: NATPARA/NATPAR PTH(1-84) 100 μg subcutaneous injection once daily (single dose) |
| Treatment D | EXPERIMENTAL | Intervention: EB612 (EBP05) 2.25 mg PO TID (dose 1 and dose 2 approximately 10 hours apart; dose 2 and dose 3 approximately 5 hours apart- TID schedule option 2), for a total dose of 6.75 mg per day |
| Treatment E - EB612 (EBP05) | EXPERIMENTAL | Intervention: EB612 (EBP05) 0.75 mg PO TID (dose 1 and dose 2 approximately 10 hours apart; dose 2 and dose 3 approximately 5 hours apart- TID schedule option 2), for a total dose of 2.25 mg per day |
| Name | Type | Description |
|---|---|---|
| EB612 (EBP05) | DRUG | Entera Bio's proprietary drug for the administration of PTH(1-34) orally |
| NATPARA/NATPAR | DRUG | A PTH replacement (PTH \[1-84\]; NATPARA (Shire-NPS Pharmaceuticals, Inc., Lexington, Massachusetts) was approved by the United States (US) Food and Drug Administration (FDA) in April 2015 / NATPAR (Shire Pharmaceuticals Ltd., Dublin, Ireland) was approved by the European Medicines Agency in April 2017 for use as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Like many other hormonally active peptides, PTH (1 84); NATPARA is parenterally administered. In this protocol when a specific formulation is referenced (e.g. NATPARA) it may be read interchanged with the alternate formulation (e.g. NATPAR). |
-Criteria for Inclusion: 1. Confirmed diagnosis of primary hypoparathyroidism, as defined by the European Society of Endocrinology as a patient with hypocalcemia and inappropriately low PTH levels. If the source of hypoparathyroidism is surgical or iatrogenic, diagnosis must be for more than 1 year...