Trial · NCT07218029
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 90 months | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported. |
| Primary | Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 86 months | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported. |
| Primary | Number of Participants with Detectable Anti-Drug Antibodies (ADAs) | Up to approximately 88 months | ADAs will be detected in serum. The number of participants with detectable ADAs will be reported. |
| Primary | Laboratory parameters (Hematology): Concentration of Platelets and Hemoglobin | Up to approximately 88 months | Blood samples will be collected to determine the concentration of platelets and hemoglobin. |
| Primary | Laboratory parameters (Chemistry): Concentration of Creatinine, Total Bilirubin, and Alanine Aminotransferase (ALT) | Up to approximately 86 months | Blood samples will be collected to determine the concentration of creatinine, total bilirubin, and ALT. |
| Primary | Change From Baseline in Body Weight | Baseline and up to approximately 86 months | Change from baseline in body weight will be reported. |
| Primary | Change From Baseline in Blood Pressure | Baseline and up to approximately 86 months | Change from baseline in systolic and diastolic blood pressure will be reported. |
| Primary | Change From Baseline in Electrocardiogram (ECG) | Baseline and up to approximately 86 months | Change from baseline in ECG (12-lead) for the determination of Fridericia's corrected QT interval (QTcF) will be reported. |
| Secondary | Change From Baseline in 6-Minute Walk Distance (6MWD) | Baseline and up to approximately 48 months | The 6MWD is the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD will be reported. |
| Secondary | Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels | Baseline and up to approximately 48 months | NT-proBNP is a circulating biomarker that reflects myocardial stretch. The change from baseline in NT-proBNP levels will be reported. |
| Secondary | Change From Baseline in the Percentage of Participants Who Improve or Show Maintenance in Modified New York Heart Association/ World Health Organization Classification of Functional Status (WHO FC) | Baseline and up to approximately 48 months | The severity of participant's PAH symptoms will be graded using the WHO FC system. WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform physical activity without any symptoms, dyspnea at rest). Participants will be classified as "Improved", "No change", or "Worsened". Improved = reduction in WHO FC; No Change = no change in WHO FC; Worsened = increase in WHO FC. The change from baseline in the percentage of participants who improve or show maintenance in WHO FC will be reported. |
| Secondary | Change From Baseline in Pulmonary Vascular Resistance (PVR) | Baseline and up to approximately 48 months | PVR is a hemodynamic variable of pulmonary circulation and is measured by right heart catheterization. The change from baseline in PVR will be reported. |
| Secondary | Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low Risk Score Using the Simplified French Risk Score Calculator | Baseline and up to approximately 48 months | The simplified French Risk scoring system is based on the 2015 European Society of Cardiology/European Respiratory Society guidelines for the diagnosis and treatment of pulmonary hypertension (PH). Noninvasive parameters (WHO FC, 6MWD, NT-proBNP levels) will be used to determine the score. 'Low risk' is defined as maintaining or achieving all 3 low-risk criteria: WHO FC I or II, 6MWD \>440 meters, and NT-proBNP \<300 ng/L. The change from baseline in percentage of participants who maintain or achieve a low risk simplified French Risk score will be reported. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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