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Rezafungin for Treatment of Chronic Pulmonary Aspergillosis (CPA) in Adults With Limited Treatment Options
Sponsor: Mundipharma Research Limited
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
Conditions
Interventions
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