IMPAHCT-FUL
Research type
Research Study
Full title
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
IRAS ID
1006495
Contact name
Benjamin Dake
Contact email
Sponsor organisation
Aerovate Therapeutics, Inc.
Eudract number
2021-006864-25
Clinicaltrials.gov Identifier
Research summary
Research Summary: IMPAHCT-FUL: Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (LTE) Trial is a follow up study to establish the long-term safety of AV-101. The long-term effects of AV-101 on efficacy measures will also be assessed. Subjects who successfully complete the 24-week placebo-controlled parent trial (AV-101-002) will be offered the opportunity to continue into this LTE study. Subjects who enroll in the study will receive one of three active AV-101 doses until such time as the optimal dose has been selected in the parent study.
Summary of Results: The Summary of Results and corresponding Lay Summary of Study Results will be available in the EU Clinical Trials Register (https://euclinicaltrials.eu/) within the timeframe required for posting of trial results. Clinicaltrials.gov (https://clinicaltrials.gov) will also be updated with results information in accordance with the applicable requirements.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
22/SC/0416
Date of REC Opinion
3 Feb 2023
REC opinion
Further Information Favourable Opinion