Expanded Access Program of Palopegteriparatide in Patients With Hypoparathyroidism

NCT05654701 | Unknown

• 1 other identifier: ASNDMAP001
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Hypoparathyroidism; Parathyroid Hormone; TransCon PTH; PTH(1-34); Expanded Access

Interventions

Palopegteriparatide (TransCon PTH) DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of hypoparathyroidism.
• Patients with previous PTH-treatment experience.
• Serum albumin-adjusted calcium level ≥7.8 mg/dL and 25(OH) vitamin D in the normal range within 2 weeks before first dose.
• Body mass index (BMI) 17 - 40 kg/m2.
• Be willing and able to give written informed consent by signing an Institutional Review Board (IRB)-approved Informed Consent Form (ICF).

You may not qualify if:

• Diagnosis of pseudohypoparathyroidism.
• Currently enrolled in an investigational drug or device study or has used an investigational drug or device within 30 days or 5 half-lives (whichever is longer) of Day 1.
• Severe renal impairment (estimated glomerular filtration rate \<30 mL/min/1.73m2).
• Increased risk for osteosarcoma, such as those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, hereditary disorders predisposing to osteosarcoma, or with a prior history of substantial external beam or implant radiation therapy involving the skeleton
• Active malignancy within past 2 years excluding successfully resected thyroid carcinoma and non-melanoma skin cancer.
• Severe or decompensated cardiac disease within 26 weeks, including but not limited to class IV or Stage D heart failure, unstable angina, myocardial infarction or uncontrolled arrhythmias.
• Pregnant or lactating females, or females intending to become pregnant.
• Known allergy and/or sensitivity to palopegteriparatide or its excipients or prior PTH therapy.

Sponsors & Collaborators

• Ascendis Pharma Bone Diseases A/S: lead

MeSH Terms

Conditions

Hypoparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 16, 2022
• Last Updated: June 27, 2025

Record last verified: 2025-06