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NCT04009291 · ClinicalTrials.gov registry record · Phase 2
A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH in Adults With Hypoparathyroidism
A Phase 2 study, sponsored by Ascendis Pharma A/S.
- Completed
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
NCT04009291 is a Phase 2 study that has completed, run by Ascendis Pharma A/S. The registered enrollment target is 59 participants.
The verdict
NCT04009291, a Phase 2 study, has completed, sponsored by Ascendis Pharma A/S.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
Study 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.
Interventions
- COMBINATION_PRODUCT TransCon PTH
- COMBINATION_PRODUCT Placebo for TransCon PTH
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2019-08-27 |
| Est. Completion | 2025-04-17 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04009291
The ClinicalTrials.gov registry entry for NCT04009291 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ascendis Pharma A/S, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which TransCon PTH is the first listed.
NCT04009291 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04009291 about?
NCT04009291 is a clinical study titled "A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH in Adults With Hypoparathyroidism". 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...
What is the current status of trial NCT04009291?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2019-08-27. Estimated completion is 2025-04-17.
What interventions are being tested in trial NCT04009291?
The interventions under investigation include: TransCon PTH (COMBINATION_PRODUCT), Placebo for TransCon PTH (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04009291?
This trial is sponsored by Ascendis Pharma A/S, which has 9 total clinical trials registered on ClinicalTrials.gov.
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