At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
PaTH Forward: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial With an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults With Hypoparathyroidism
In Brief
A Phase 2 clinical trial evaluating TransCon PTH and Placebo for TransCon PTH for Hypoparathyroidism and 2 related conditions. Completed, enrolled 59 participants across 15 sites in 6 countries.
Signals
Detailed Summary
During the first four weeks of the trial, participants were randomly assigned to one of four groups: three groups received fixed doses of TransCon PTH and one group received placebo. TransCon PTH or placebo were administered as a subcutaneous injection using a pre-filled injection pen. Neither trial participants nor their doctors know who has been assigned to each group. After the four weeks, participants continued in the trial as part of a long-term extension period. 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, Italy and Norway.
Study Details
Timeline
Arms & Interventions
TransCon PTH 15 mcg delivered once daily by subcutaneous injection
TransCon PTH 18 mcg delivered once daily by subcutaneous injection
TransCon PTH 21 mcg delivered once daily by subcutaneous injection
Placebo mimicking 15, 18, or 21 mcg of TransCon PTH delivered once daily by subcutaneous injection
Participants who completed the 4-week double-blind period, continued into the open-label extension period and received treatment with TransCon PTH up to Week 266, with up to an initial 14 weeks of TransCon PTH titration and standard of care optimization, followed by approximately 248 weeks of individualized doses of TransCon PTH (allowable dose range: 6 to 60 mcg/day).
Interventions
TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection.
Placebo is supplied as a clear solution containing the formulation buffer for TransCon PTH in a pre-filled pen intended for subcutaneous injection.