Expanded Access Program of Palopegteriparatide in Patients With Hypoparathyroidism
- Sponsor
- Ascendis Pharma Bone Diseases A/S
- Study ID
- NCT05654701
- Status
- Approved For Marketing
Conditions
- Hypoparathyroidism
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Palopegteriparatide (TransCon PTH) — DRUGThe 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.
Study Details
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.
Key Dates
- Status verified
- Jun 2025
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- Parathyroid Allotransplant for Treatment of HypoparathyroidismPHASE1/PHASE2 · Recruiting · Peter Stock · San Francisco, California
- A Phase 3 Randomized Clinical Trial to Investigate the Safety and Efficacy of Palopegteriparatide at Doses Greater Than 30 μg/Day in Adult Participants With HypoparathyroidismPHASE3 · Recruiting · Ascendis Pharma Bone Diseases A/S · Reno, Nevada