A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Daily in Adults With Hypoparathyroidism
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.
Timeline
- Start
- 2021-02-16
- Primary completion
- 2022-01-12
- Completion
- 2025-01-21
Outcome
Met primary endpoint
registry NUMBER TransCon PTH: 78.7 (66.3 to 88.1) Percentage of participants NCT04701203 ↗
registry analysis (superiority test); TransCon PTH vs Placebo; p <0.0001; t-test, 2 sided NCT04701203 ↗
Publications
- Brod M, Pfeiffer KM, Beck JF, Smith A. Measuring treatment impacts on symptoms in adults with hypoparathyroidism: findings from the PaTHway trial. J Patient Rep Outcomes. 2024 Aug 13;8(1):94. doi: 10.1186/s41687-024-00757-1.
- Rejnmark L, Gosmanova EO, Khan AA, Makita N, Imanishi Y, Takeuchi Y, Sprague S, Shoback DM, Kohlmeier L, Rubin MR, Palermo A, Schwarz P, Gagnon C, Tsourdi E, Zhao C, Makara MA, Ominsky MS, Lai B, Ukena J, Sibley CT, Shu AD. Palopegteriparatide Treatment Improves Renal Function in Adults with Chronic Hypoparathyroidism: 1-Year Results from the Phase 3 PaTHway Trial. Adv Ther. 2024 Jun;41(6):2500-2518. doi: 10.1007/s12325-024-02843-8. Epub 2024 Apr 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Palopegteriparatide | Unknown | 18 ug | Subcutaneous |