IMPAHCT-FUL: A Long-Term Extension, Multi-Center Safety Study of AV-101 in Subjects With Pulmonary Arterial Hypertension (PAH) Who Have Completed Study AV-101-002

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508735-31-00

Acronym

AV-101-003

Enrollment

205

Registered

2024-03-12

Start date

2023-05-05

Completion date

2024-07-18

Last updated

2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension (PAH)

Brief summary

Safety and tolerability of AV-101, Change from baseline in the 6MWD, Change from baseline in NT-proBNP, Time to Clinical Worsening events, Change from baseline in Transthoracic Echo parameters of right ventricular (RV) function

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of AV-101, Change from baseline in the 6MWD, Change from baseline in NT-proBNP, Time to Clinical Worsening events, Change from baseline in Transthoracic Echo parameters of right ventricular (RV) function	—

Countries

Austria, Belgium, Czechia, France, Germany, Greece, Ireland, Italy, Latvia, Netherlands, Poland, Portugal, Spain, Sweden

Outcome results