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Safety Extension Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Safety Extension Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis

An Open-label, Non-controlled, Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis Patients

NCT03482752•Savara Inc.

View on ClinicalTrials.gov

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 molgramostim (recombinant human Granulocyte-Macrophage Colony Stimulating Factor; GM-CSF) administered intermittently in cycles of seven days molgramostim, administered once daily, and seven days off treatment. Participants will be treated with inhaled molgramostim for up to 36 months. During the trial, whole lung lavage will be applied as rescue therapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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.

Locations (13)

Dept. Of Respiratory Diseases & Allergy

Aarhus, Denmark

CHU Rennes Hospital Pontchaillou, Service de Pneumologie

Rennes, France

Ruhrlandklinik Essen Westdeutsches Lungenzentrum am Universitätsklinikum Essen GmbH

Essen, Germany

Asklepios Fachkliniken München - Gauting Klinik für Pneumologie

Gauting, Germany

Thoraxklinik am Universitätsklinikum Heidelberg Abteilung für Pneumologie und Beatmungsmedizin

Heidelberg, Germany

Universitätsklinikum Schleswig-Holstein Zentralklinikum Lübeck Medizinische Klinik III - Pneumologie

Lübeck, Germany

Attikon University Hospital 2nd Pulmonary Department Athens Medical School National and Kapodistrian University of Athens

Athens, Greece

Rabin Medical Center Institute of Pulomonary Medicine

Tel Aviv, Israel

S.C. Pneumologia Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

St. Antonius Hospital

Nieuwegein, Netherlands

Key Dates

Start Date

April 16, 2018

Primary Completion Date

January 14, 2021

Completion Date

January 14, 2021

Last Updated

July 3, 2024

Enrollment

ACTUAL participants

Conditions

Autoimmune Pulmonary Alveolar Proteinosis

Interventions

Molgramostim

DRUG

Pioglitazone Therapy of Autoimmune Pulmonary Alveolar Proteinosis Autoimmune Pulmonary Alveolar Proteinosis

NCT03231033

Autoimmune Pulmonary Alveolar Proteinosis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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