Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by Ascendis Pharma A/S.
NCT04009291 is a Phase 2 study that has completed, run by Ascendis Pharma A/S. The registered enrollment target is 59 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The percentage of subjects with albumin-adjusted serum calcium within the normal range, and spot morning fractional excretion of calcium (spot AM FECa) within normal range (≤2%) or a reduction by at least 50% from baseline, and not taking active vitamin D supplements, and taking ≤1000 mg/day of calcium supplements
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 |
What the finished NCT04009291 record still lists
NCT04009291 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 2 interventions - of which TransCon PTH is the first listed.
NCT04009291 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04009291's enrollment target sits among peer trials
59 1133rd of 2000 higher than 866 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03801083 · 59 participants · Phase 2
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers
- NCT04332367 · 59 participants · Phase 2
Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance
- NCT05489575 · 59 participants · NA
CPAP for the Treatment of Supine Hypertension
- NCT06721689 · 59 participants · Phase 1
PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI