CompletedPhase 3

A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Daily in Adults With Hypoparathyroidism

United States84 participantsStarted 2021-02-16

Plain-language summary

During the first 26 weeks of the trial, participants were randomly assigned to one of two groups: one group received TransCon PTH and one group received placebo. All participants started with study drug at a dose of 18 mcg/day and were individually and progressively titrated to an optimal dose in dose increments of 3 mcg/day. TransCon PTH or placebo were administered as a subcutaneous injection using a pre-filled injection pen. Neither trial participants nor their doctors knew who had been assigned to each group. After the 26 weeks, participants continued in the trial as part of a long-term extension study. During the extension, all participants received TransCon PTH, with the dose adjusted to their individual needs. This was a global trial that was conducted in the United States, Canada, Germany, Denmark, Norway, Italy, and Hungary.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Males and females, ≥18 years of age
✓. Subjects with postsurgical chronic HP, or auto-immune, genetic, or idiopathic HP for at least 26 weeks. Diagnosis of HP is established based on historic hypocalcemia in the setting of inappropriately low serum PTH levels
✓. Requirement for doses of SoC (e.g., calcitriol, alfacalcidol, calcium supplements) at or above a minimum threshold:
✓. Optimization of supplements prior to randomization to achieve the target serum levels of:
✓. The subject demonstrates a 24-hour uCa excretion of ≥125 mg/24h (on a sample collected within 52 weeks prior to Screening or during the Screening Period)
✓. BMI 17- 40 kg/m2 at Screening
✓. If ≤25 years of age, radiological evidence of epiphyseal closure based on X-ray of nondominant wrist and hand
✓. Thyroid-stimulating hormone (TSH) within normal laboratory limits within the 6 weeks prior to Visit 1; if on suppressive therapy for a history of thyroid cancer, TSH level must be ≥0.2 mIU/mL

Exclusion criteria

What they're measuring

Efficacy - Primary Endpoint During the Blinded Period

Timeframe: 26 weeks

Trial details

NCT IDNCT04701203

SponsorAscendis Pharma Bone Diseases A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-01-12

Results submitted2024-08-09

View on ClinicalTrials.gov More Hypoparathyroidism trials