Non-interventional, Postauthorization Safety Study of Ventavis for Pulmonary Arterial Hypertension (PAH)

Completed

• Conditions: Hypertension, Pulmonary
• Interventions: Drug: Ventavis (Iloprost, BAYQ6256)

• Registration Number: NCT02825160
• Lead Sponsor: Bayer

Brief Summary

This study is collecting post-marketing information on the safety and effectiveness of Ventavis under the routine clinical practice for patients with PAH

Detailed Description

This local, prospective, non-interventional, company sponsored, multi-center, single-cohort study includes patients treated with Ventavis for PAH. A total of 270 patients (valid for safety analysis) is planned to be enrolled in 5 years. Target population is patients with PAH diagnosis. This study is performed as an all-patient investigation, therefore all patients who receive Ventavis treatment for PAH need to be registered. The treatment should be performed based on the product label in Japan. The standard observation period will last for 12 months from starting Ventavis treatment. In addition, the extension observation will be carried out as long as Ventavis treatment continues or at most for more 4 years. The standard observation points are 3 month and

1 to 5 years.

Study Timeline

• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-07-04
• Study First Posted: 2016-07-07
• Study Start: 2016-08-01
• Primary Completion: 2023-03-31
• Study Completion: 2023-09-27
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

• Patients diagnosed with PAH
• Patients for whom the decision to initiate treatment with Ventavis was made as per investigator's routine treatment practice.

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Exclusion Criteria

• N/A

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ventavis	Ventavis (Iloprost, BAYQ6256)	Ventavis treatment group

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment emergent adverse events (TEAE) of special interest.	Up to 5 years	TEAE of special interest: * Hypotension; * Syncope; * Local irritation; * Bleeding events; * Thrombocytopenia; * Tachycardia
Number of participants with adverse drug reaction	Up to 5 years

Secondary Outcome Measures

Name	Time	Method
Change from baseline in tricuspid regurgitation pressure gradient (TRPG) after 3 and 12 months	Baseline and 3 months,Baseline and 12 months
Change from baseline in 6-Minute Walking Distance after 3 and 12 months	Baseline and 3 months,Baseline and 12 months
Change in blood concentration from baseline in brain natriuretic peptide / N-terminal pro-brain natriuretic peptide (BPN/NT-pro BNP) after 3 and 12 months.	Baseline and 3 months,Baseline and 12 months
Change from baseline in Pulmonary Vascular Resistance (PVR) after 3 and 12 months	Baseline and 3 months,Baseline and 12 months,
Change from baseline in WHO functional class after 3 and 12 months	Baseline and 3 months,Baseline and 12 months,
Time to Clinical Worsening	Up to 5 years	The 1st occurrence date of one of the following events is recorded and used for the calculation of time to clinical worsening: * Death (all-cause mortality), -Heart/lung transplantation, -Atrial Septostomy,; * Hospitalization due to persistent worsening of Pulmonary Hypertension (PH),; * Start of new PH specific treatment or modification of a preexisting Prostacycline analogues treatment except Ventavis due to worsening PH,; * Persistent decrease in 6MWD due to worsening PH,; * Persistent worsening of WHO functional class due to deterioration of PH

Trial Locations

Locations (1)

Many Locations; 🇯🇵 Multiple Locations, Japan