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RECRUITING
NCT06794554
PHASE2

Rezafungin for Treatment of Chronic Pulmonary Aspergillosis (CPA) in Adults With Limited Treatment Options

Sponsor: Mundipharma Research Limited

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to to evaluate the drug rezafungin in the treatment of Chronic Pulmonary Aspergillosis (CPA) in male and female patients aged 18 years and over with limited treatment options. The study aims to answer whether 6 months of rezafungin treatment is effective and safe in patients with chronic pulmonary aspergillosis with limited treatment options according to clinical and radiological response as measured by the St George's Respiratory Questionnaire, weight, and CT imaging. Participants will: * Be given the drug rezafungin every week for 6 months. * Visit the clinic once a month for checkups and tests. * Complete questionnaires on thier health and wellbeing.

Official title: A Phase 2, Multicentre, Open-label, Single Arm Study to Evaluate the Effectiveness and Safety of Rezafungin (as Acetate) in the Treatment of Chronic Pulmonary Aspergillosis (CPA) in Patients With Limited Treatment Options

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-06-30

Completion Date

2026-12-30

Last Updated

2025-08-29

Healthy Volunteers

No

Interventions

DRUG

Rezafungin Acetate

IV with a 400 mg loading dose on Day 1 of Week 1, followed by 200 mg once weekly, for a total of 26 doses (6 months).

Locations (37)

Kepler University Hospital

Linz, Austria

Brussels University Hospital

Brussels, Belgium

UZ Gent

Ghent, Belgium

University Hospital Leuven

Leuven, Belgium

CHU UCL Namur

Yvoir, Belgium

CHU Amiens Picardie

Amiens, France

Institut Coeur Poumon CHU

Lille, France

CHU Arnaud de Villeneuve

Montpellier, France

CHU Bordeaux

Pessac, France

CHU de Rouen

Rouen, France

Evangelische Lungenklinik Berlin

Berlin, Germany

University of Cologne

Cologne, Germany

Asklepios Lungenfachklinik Gauting

Gauting, Germany

Országos Korányi Pulmonológiai Intézet

Budapest, Hungary

University of Genova, San Martino Hospital

Genova, Italy

University of Pisa

Pisa, Italy

INMI Lazzaro Spallanzaniconsu

Roma, Italy

Humanitas Research Hospital

Rozzano, Italy

Radboud Universitair Medisch Centrum Stichting

Nijmegen, Netherlands

Chonnam National University Hospital

Gwangju, South Korea

Seoul National University Bundang Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitari de Bellvitge

Barcelona, Spain

Vall d'Hebron Barcelona Hospital Campus

Barcelona, Spain

Ramón y Cajal Hospital

Madrid, Spain

Hospital Sant Joan de Deu de Martorell

Martorell, Spain

Hospital La Fe

Valencia, Spain

Royal Papworth Hospital

Cambridge, United Kingdom

University Hospitals of Derby and Burton

Derby, United Kingdom

Western General Hospital

Edinburgh, United Kingdom

Leeds Teaching Hospital

Leeds, United Kingdom

Imperial College Hospital

London, United Kingdom

Royal Brompton Hospital, Guy's and St. Thomas' Hospital

London, United Kingdom

University College London (UCL) Hospitals

London, United Kingdom

Manchester University Hospital

Manchester, United Kingdom