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

Drug Use Investigation of Ventavis for Pulmonary Arterial Hypertension (PAH)

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

Study Overview

• Status: Completed
• Conditions: Hypertension, Pulmonary
• Intervention / Treatment: Drug: Ventavis (Iloprost, BAYQ6256)

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 Type: Observational
• Enrollment (Actual): 295

Contacts and Locations

Study Locations

• Japan
  • Multiple Locations, Japan
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Study population includes PAH patients treated with Ventavis. This study is performed as an all-case investigation. Therefore, all patients who have been treated with Ventavis for PAH need to be registered in principle, until the target number of patients reached.

Description

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.

Exclusion Criteria:

- N/A

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ventavis; Ventavis treatment group	Drug: Ventavis (Iloprost, BAYQ6256); The treatment of Ventavis should comply with the local product information

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in tricuspid regurgitation pressure gradient (TRPG) 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 6-Minute Walking Distance 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	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	Up to 5 years

Collaborators and Investigators

• Sponsor: Bayer
• Investigators: Study Director: Bayer Study Director, Bayer

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): September 27, 2023

Study Registration Dates

• First Submitted: June 15, 2016
• First Submitted That Met QC Criteria: July 4, 2016
• First Posted (Estimated): July 7, 2016

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Iloprost; Pulmonary arterial hypertension; Japan; Post-marketing surveillance; Ventavis; Prostacycline analogue
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Vasodilator Agents; Platelet Aggregation Inhibitors; Iloprost
• Other Study ID Numbers: 17941

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No