Trials / Completed
CompletedNCT04009291
A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH in Adults With Hypoparathyroidism
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 59 (actual)
- Sponsor
- Ascendis Pharma A/S · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
During the first four weeks of the trial, participants will be randomly assigned to one of four groups: three groups will receive fixed doses of TransCon PTH and one group will receive placebo. TransCon PTH or placebo will be administered as a subcutaneous injection using a pre-filled injection pen. Neither trial participants nor their doctors will know who has been assigned to each group. After the four weeks, participants will continue in the trial as part of a long-term extension study. During the extension, all participants will receive TransCon PTH, with the dose adjusted to their individual needs. This is a global trial that will be conducted in, but not limited to, the United States, Canada, Germany, Denmark, and Norway.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | TransCon PTH | 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. |
| COMBINATION_PRODUCT | Placebo for TransCon PTH | Placebo is supplied as a clear solution containing the formulation buffer for TransCon PTH in a pre-filled pen intended for subcutaneous injection. |
Timeline
- Start date
- 2019-08-27
- Primary completion
- 2020-03-06
- Completion
- 2025-04-17
- First posted
- 2019-07-05
- Last updated
- 2025-05-08
- Results posted
- 2023-09-01
Locations
15 sites across 6 countries: United States, Canada, Denmark, Germany, Italy, Norway
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04009291. Inclusion in this directory is not an endorsement.