Trial design
PaTHway
HYPOPARATHYROIDISM
PaTHway is a phase 3, multicenter (North America and Europe), randomized, double‐blind, placebo‐controlled, parallel‐group, 26‐week trial with an open‐label extension of 156 weeks that evaluated the efficacy, safety, and tolerability of once‐daily TransCon PTH as PTH replacement therapy in individuals with hypoparathyroidism. Screening for the trial began on February 15, 2021. The last participant completed the blinded portion of the trial on January 12, 2022, and the open‐label extension is ongoing. The trial consisted of an approximately 4‐week screening period followed by a 26‐week blinded treatment period. All participants who completed the 26‐week blinded treatment period were allowed to enroll in the 156‐week open‐label extension period. Data through week 26 of the PaTHway trial are reported herein. The protocol was reviewed by the appropriate institutional review boards and independent ethics committees (ClinicalTrials.gov identifier: NCT04701203; EudraCT no: 2020‐003380‐26). The trial was designed by the sponsor and authors and conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines as described in the International Conference on Harmonization Guideline E6.