Trial · NCT06350032
Investigational Trial to Evaluate Safety and Tolerability of Treprostinil in Children Diagnosed With PAH
NCT06350032, Phase 3, Recruiting, AOP Orphan Pharmaceuticals AG
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Investigational Trial to Evaluate Safety and Tolerability of Treprostinil in Children Diagnosed With PAH. Trials, record NCT06350032. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06350032
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Investigational Trial to Evaluate Safety and Tolerability of Treprostinil in Children Diagnosed With PAH
- NCT number
- NCT06350032
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 20 participants, estimated
- Lead sponsor
- AOP Orphan Pharmaceuticals AG
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- preservative-free parenteral treprostinil
- First posted
- 2024-04-05
- Last updated
- 2026-10-29
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency and seriousness of adverse events and adverse drug reactions | 5 months (20 weeks ± 1 weeks) | The frequency and seriousness of adverse events and adverse drug reactions during the first 5 months (20 weeks ± 1 weeks) of treatment according to Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). |
| Other | Change from baseline in quality of Life (QoL) | 5 months (20 weeks ± 1 weeks) | Change from baseline in quality of Life (QoL) as assessed by the Pediatric Quality of Life Inventory (PedsQoL Version 4.0) questionnaire. Rating from 0 (never) to 4 (almost always) per question. Questionnaire will be completed by pediatric patient (version appropriate for age group) and parents/caregivers. |
| Other | Change from baseline in 6-minute walk distance (6MWD) | 5 months (20 weeks ± 1 weeks) | Change from baseline in 6MWD (patients \> 6 years) |
| Other | Change from baseline in World Health Organization Functional Class (WHO FC) | 5 months (20 weeks ± 1 weeks) | Change in WHO FC class assessment based on current PH guidelines ranging from class I to class IV, whereas class IV means severe limitations. |
| Other | Change from baseline in echocardiography (ECHO) parameters - RA/RV enlargement | 5 months (20 weeks ± 1 weeks) | right atrium (RA) / right ventricle (RV) |
| Other | Change from baseline in echocardiography (ECHO) parameters - RV systolic dysfunction | 5 months (20 weeks ± 1 weeks) | |
| Other | Change from baseline in echocardiography (ECHO) parameters - RV/LV end-systolic ratio (PSAX) | 5 months (20 weeks ± 1 weeks) | RV / left ventricle (LV) |
| Other | Change from baseline in echocardiography (ECHO) parameters - tricuspid annular plane systolic excursion (TAPSE) | 5 months (20 weeks ± 1 weeks) | |
| Other | Change from baseline in echocardiography (ECHO) parameters - S/D ratio (TR jet) | 5 months (20 weeks ± 1 weeks) | |
| Other | Change from baseline in echocardiography (ECHO) parameters - Pulmonary Artery Acceleration Time (PAAT) | 5 months (20 weeks ± 1 weeks) |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06350032
GET https://conductscience.org/api/trials/v1/NCT06350032/registered