Expanded Access Program of Palopegteriparatide in Patients With Hypoparathyroidism
NCT05654701 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS
Last updated 2025-06-27
Summary
To provide palopegteriparatide (TransCon PTH), an investigational parathyroid hormone (PTH) replacement therapy in an expanded access setting for adult patients with hypoparathyroidism who have previously received PTH-treatment, who meet the eligibility criteria for this protocol as described below and have a clear unmet medical need that cannot be adequately treated by a commercial product or a clinical trial.
Conditions
- Hypoparathyroidism
Interventions
- DRUG
-
Palopegteriparatide (TransCon PTH)
The investigational drug Palopegteriparatide (TransCon PTH) 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.
Sponsors & Collaborators
-
Ascendis Pharma Bone Diseases A/S
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
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