A Study to Test the Effects and Safety of Palopegteriparatide in Adolescents With Long-term Hypoparathyroidism

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-18
SponsorAscendis Pharma A/S

About this trial

This trial will enroll adolescents between ages of ≥12 and \<18 years with clinically diagnosed hypoparathyroidism . The purpose of the study is to see how well treatment with once-daily palopegteriparatide works and how safe it is. At least 12 participants will receive palopegteriparatide for 234 weeks. This trial will be conducted in Europe.

Eligibility criteria

Qualifiers

1. Males and females, 12 to less than 18 years of age

2. Participants with postsurgical chronic hypoparathyroidism, or auto-immune, genetic, or idiopathic hypoparathyroidism for at least 26 weeks

3. Normal levels of serum 25(OH) vitamin D and magnesium

4. Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73

Disqualifiers

1. Impaired responsiveness to PTH which is characterized as PTH-resistance, with elevated PTH levels in the setting of hypocalcemia

2. Any disease that might affect calcium metabolism or calcium-phosphate homeostasis or PTH levels other than hypoparathyroidism, such as active hyperthyroidism

3. Use of loop diuretics, phosphate binders (other than calcium supplements), digoxin, lithium, methotrexate, biotin >30 µg/day, or systemic corticosteroids (other than as replacement therapy). Short course use of steroids (≤2 weeks/year) equivalent to prednisone ≤60 mg/day is permitted

4. Use of thiazide diuretic

Trial design

Treatments tested in this trial

  • Palopegteriparatide

Treatment groups

12 Participants
are divided into 1 treatment group

Sponsors and collaborators