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NCT05654701
Expanded Access Program of Palopegteriparatide in Patients With Hypoparathyroidism
Conditions: Hypoparathyroidism
Sex: All
Ages: 18 Years – N/A
Sponsor: Ascendis Pharma Bone Diseases A/S
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.
Eligibility Criteria
Inclusion Criteria: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).Exclusion Criteria: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 skeletonActive 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.
Source: ClinicalTrials.gov (NCT05654701). StuddyBuddy aggregates publicly available trial information.
