Expanded Access Program of Palopegteriparatide in Patients with Hypoparathyroidism

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Description

To provide palopegteriparatide, an investigational PTH replacement therapy in an expanded access setting (as described in 21 U.S.C. Section 360bbb) for patients with hypoparathyroidism who have previously received PTH-treatment, who meet the eligibility criteria for this protocol as described below, and with a clear unmet medical need that cannot adequately be treated by a commercial product or a clinical trial.

Details
Age
Adult
Eligibility
Inclusion Criteria: 1. Diagnosis of hypoparathyroidism. 2. Patients with previous PTH-treatment experience. 3. Serum albumin-adjusted calcium level ≥7.8 mg/dL and 25(OH) vitamin D in the normal range within 2 weeks before first dose. 4. Male or female at least 18 years of age. 5. Body mass index (BMI) 17 – 40 kg/m2. 6. Be willing and able to give written informed consent by signing an Institutional Review Board (IRB)-approved Informed Consent Form (ICF). Exclusion Criteria: 1. Diagnosis of pseudohypoparathyroidism. 2. 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. 3. Severe renal impairment (estimated glomerular filtration rate <30 mL/min/1.73m2). 4. 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. 5. Active malignancy within past 2 years excluding successfully resected thyroid carcinoma and non-melanoma skin cancer. 6. 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. 7. Pregnant or lactating females, or females intending to become pregnant. 8. Known allergy and/or sensitivity to palopegteriparatide or its excipients or prior PTH therapy. Given the expanded access nature of this program, exemptions may be granted at the discretion of the Sponsor.
Locations

University of Colorado Hospital

Principal Investigator
Photograph of Micol Rothman

Micol Rothman

Study ID

Protocol Number: 23-0912

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