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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04701203 | A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Daily in Adults With Hypoparathyroidism | PHASE3 | COMPLETED | 84 | — | — | Feb 16, 2021 | Jan 21, 2025 | Feb 9, 2026 | 21 | United States, Canada +5 |
| NCT04009291 | A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH in Adults With Hypoparathyroidism | PHASE2 | COMPLETED | 59 | — | — | Aug 27, 2019 | Apr 17, 2025 | May 8, 2025 | 15 | United States, Canada +4 |
The primary endpoint was a multi-component endpoint that included the percentage of participants who met the following criteria at 26 weeks of blinded treatment: 1) albumin-adjusted serum calcium measured within 4 weeks prior to and on Week 26 visit within the normal range (8.3 to 10.6 mg/dL), and 2) independence from active vitamin D within 4 weeks prior to Week 26 visit (i.e., all daily standing dose of active vitamin D equal to zero AND use of PRN ≤7 days during the 4 weeks), and 3) independence from therapeutic doses of calcium within 4 weeks prior to Week 26 visit (i.e., average daily standing dose of elemental calcium ≤600 mg AND use of PRN doses on ≤7 days during the 4 weeks), and 4) no increase in prescribed study drug within 4 weeks prior to Week 26 visit.
| Arm | Type | Description |
|---|---|---|
| TransCon PTH | EXPERIMENTAL | TransCon PTH at a starting dose of 18 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose |
| Placebo | PLACEBO_COMPARATOR | Placebo for TransCon PTH delivered once daily by subcutaneous injection |
| TransCon PTH 15 mcg | EXPERIMENTAL | TransCon PTH 15 mcg delivered once daily by subcutaneous injection |
| TransCon PTH 18 mcg | EXPERIMENTAL | TransCon PTH 18 mcg delivered once daily by subcutaneous injection |
| TransCon PTH 21 mcg | EXPERIMENTAL | TransCon PTH 21 mcg delivered once daily by subcutaneous injection |
| Open-Label Extension Period | EXPERIMENTAL | Subjects who complete the four-week blinded period are assigned to open-label treatment with TransCon PTH for up to 262 weeks, with up to an initial 14 weeks of TransCon PTH titration and standard of care optimization, followed by approximately 248 weeks of individualized dosing. |
| Name | Type | Description |
|---|---|---|
| TransCon PTH | COMBINATION_PRODUCT | TransCon PTH drug product is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended for subcutaneous injection. |
| Placebo | COMBINATION_PRODUCT | Placebo is supplied as a solution containing the formulation buffer for TransCon PTH in a single-patient-use prefilled pen intended for subcutaneous injection. |
| Placebo for TransCon PTH | COMBINATION_PRODUCT | Placebo is supplied as a clear solution containing the formulation buffer for TransCon PTH in a pre-filled pen intended for subcutaneous injection. |
Inclusion Criteria: 1. Males and females, ≥18 years of age 2. Subjects with postsurgical chronic HP, or auto-immune, genetic, or idiopathic HP for at least 26 weeks. Diagnosis of HP is established based on historic hypocalcemia in the setting of inappropriately low serum PTH levels 3. Requirement f...