Status:
TERMINATED
Safety Extension Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis
Lead Sponsor:
Savara Inc.
Conditions:
Autoimmune Pulmonary Alveolar Proteinosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
SAV006-03 is an open-label extension study for participants who had completed the IMPALA study. At the baseline visit, eligible participants may continue or re-start treatment with 300 µg inhaled mol...
Eligibility Criteria
Inclusion
- Completer of the IMPALA trial.
- Females who have been post menopausal for \>1 year, or females of child-bearing potential who are not pregnant or lactating and are using acceptable contraceptive methods.
- Males agreeing to use using acceptable contraceptive methods.
- Willing and able to provide signed informed consent.
Exclusion
- Treatment with GM-CSF products other than molgramostim nebuliser solution within three months of Baseline.
- Treatment with any investigational medicinal product other than inhaled molgramostim within four weeks of Baseline.
- History of allergic reactions to GM-CSF.
- Connective tissue disease, inflammatory bowel disease or other autoimmune disorder requiring treatment associated with significant immunosuppression, e.g. more than 10 mg/day systemic prednisolone.
- Previous experience of severe and unexplained side effects during aerosol delivery of any kind of medicinal product.
- History of, or present, myeloproliferative disease or leukaemia.
- Apparent pre-existing concurrent pulmonary fibrosis.
- Any other serious medical condition which in the opinion of the investigator would make the subject unsuitable for the trial.
Key Trial Info
Start Date :
April 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03482752
Start Date
April 16 2018
End Date
January 14 2021
Last Update
July 3 2024
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Dept. Of Respiratory Diseases & Allergy
Aarhus, Denmark
2
CHU Rennes Hospital Pontchaillou, Service de Pneumologie
Rennes, France
3
Ruhrlandklinik Essen Westdeutsches Lungenzentrum am Universitätsklinikum Essen GmbH
Essen, Germany
4
Asklepios Fachkliniken München - Gauting Klinik für Pneumologie
Gauting, Germany