Savara Trials - LARVOL Sigma

Trial + Data / Events

Status

Region

Interventions

Sponsor

Conditions

Primary compl

Study compl

sodium nitrite inhalation (AIR001) / Savara

NCT02694393: Inhaled Sodium Nitrite as an Antimicrobial for Cystic Fibrosis

Terminated

1/2

sodium nitrite, AIR001

Schmidhofer, Mark, MD, Mast Therapeutics, Inc., Cystic Fibrosis Foundation

Cystic Fibrosis

07/22

Molbreevi (molgramostim) / Savara, Nobelpharma

2020-001263-85: A clinical trial where patients with the lung disease autoimmune Pulmonary Alveolar Proteinosis will be given the drug molgramostim nebulizer solution by inhalation.

Ongoing

160

Europe

Molgramostim 300 Âµg nebulizer solution, [na], Nebulisation solution

Savara ApS, SAVARA APS, Savara ApS,

Autoimmune Pulmonary Alveolar Proteinosis (aPAP), Pulmonary Alveolar Proteinosis, commonly known by the acronym PAP, is a rare lung disease characterized by the build-up of proteinaceous material in the alveoli (air sacs) of the lungs., Diseases [C] - Respiratory Tract Diseases [C08]

IMPALA-2, NCT04544293 / 2020-001263-85: Clinical Trial of Inhaled Molgramostim Nebulizer Solution in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

Active, not recruiting

160

Europe, Canada, Japan, US, RoW

Molgramostim, Recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF), Placebo

Savara Inc., Savara ApS,

Autoimmune Pulmonary Alveolar Proteinosis

11/23

11/24

NCT06431776: Inhaled Molgramostim in Pediatric Participants With Autoimmune Pulmonary Alveolar Proteinosis (aPAP).

Not yet recruiting

Molgramostim, Recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF).

Savara Inc.

Autoimmune Pulmonary Alveolar Proteinosis

01/27

08/27

2017-003374-14: A pilot clinical trial of inhaled molgramostim in patients with antibiotic-resistant bacterial infection.

Not yet recruiting

Europe

Molgramostim nebuliser solution (Molgradex), Nebuliser solution

Savara ApS, Savara ApS

Treatment-resistant pulmonary non-tuberculosis mycobacterial (NTM) infection, Lung infection, Diseases [C] - Respiratory Tract Diseases [C08]

2020-001654-21: Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) Inhalation to prevent ARDS in COVID-19 pneumonia Granulozyten-Monozyten-Kolonie-stimulierende Faktor (GM-CSF) Inhalation zur Verhinderung des akuten Lungenversagens bei COVID-19-Pneumonie

Not yet recruiting

238

Europe

Molgradex 300 mcg nebuliser solution, Nebuliser solution

Justus-Liebig-University Gießen, DZL (Deutsche Zentrum für Lungenforschung)

COVID-19 pneumonia COVID-19-Pneumonie, COVID-19 pneumonia COVID-19-Pneumonie, Diseases [C] - Respiratory Tract Diseases [C08]

GI-HOPE, NCT02595060 / 2014-002479-28: Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) Inhalation to Improve Host Defense and Pulmonary Barrier Restoration

Completed

Europe

inhaled molgramostim (rhGM-CSF), inhaled placebo

University of Giessen

ARDS

09/21

07/22

GI-COVID, NCT04569877: GM-CSF Inhalation to Prevent ARDS in COVID-19 Pneumonia

Completed

Europe

Molgramostim nebuliser solution, Placebo nebuliser solution

University of Giessen

Severe Acute Respiratory Syndrome (SARS) Pneumonia, COVID-19 Pneumonia

06/22

09/22

NCT04823962: Effect of rhGM-CSF on the Healing of Venous Leg Ulcers

Active, not recruiting

Europe

rhGM-CSF + hydrogel, Repogel, Molgramostim, Placebo hydrogel, Standard care

Reponex Pharmaceuticals A/S

Venous Leg Ulcer

12/23

NCT05501340: PD-1 Inhibitor Intraperitoneal Perfusion Combined With PRaG Therapy for Malignant Ascites

Not yet recruiting

1/2

Serplulimab, HLX10, Molgramostim, rhGM-CSF, Hypofractionated radiotherapy/Sterotactic body radiotherapy

Second Affiliated Hospital of Soochow University

Malignant Ascites

12/22

09/24

NCT06546098: Molgramostim Nebulizer Solution Expanded Access Program Protocol

Available

N/A

Molgramostim nebulizer solution, Recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF)

Savara Inc.

Autoimmune Pulmonary Alveolar Proteinosis

amikacin/fosfomycin inhalation (AFIS) / Savara

No trials found

AeroVanc (vancomycin hydrochloride inhalation powder) / Savara

No trials found

Trial + Data / Events

Status

Region

Interventions

Sponsor

Conditions

Primary compl

Study compl

sodium nitrite inhalation (AIR001) / Savara

NCT02694393: Inhaled Sodium Nitrite as an Antimicrobial for Cystic Fibrosis

Terminated

1/2

sodium nitrite, AIR001

Schmidhofer, Mark, MD, Mast Therapeutics, Inc., Cystic Fibrosis Foundation

Cystic Fibrosis

07/22

Molbreevi (molgramostim) / Savara, Nobelpharma

2020-001263-85: A clinical trial where patients with the lung disease autoimmune Pulmonary Alveolar Proteinosis will be given the drug molgramostim nebulizer solution by inhalation.

Ongoing

160

Europe

Molgramostim 300 Âµg nebulizer solution, [na], Nebulisation solution

Savara ApS, SAVARA APS, Savara ApS,

IMPALA-2, NCT04544293 / 2020-001263-85: Clinical Trial of Inhaled Molgramostim Nebulizer Solution in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

Active, not recruiting

160

Europe, Canada, Japan, US, RoW

Molgramostim, Recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF), Placebo

Savara Inc., Savara ApS,

Autoimmune Pulmonary Alveolar Proteinosis

11/23

11/24

NCT06431776: Inhaled Molgramostim in Pediatric Participants With Autoimmune Pulmonary Alveolar Proteinosis (aPAP).

Not yet recruiting

Molgramostim, Recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF).

Savara Inc.

Autoimmune Pulmonary Alveolar Proteinosis

01/27

08/27

2017-003374-14: A pilot clinical trial of inhaled molgramostim in patients with antibiotic-resistant bacterial infection.

Not yet recruiting

Europe

Molgramostim nebuliser solution (Molgradex), Nebuliser solution

Savara ApS, Savara ApS

Treatment-resistant pulmonary non-tuberculosis mycobacterial (NTM) infection, Lung infection, Diseases [C] - Respiratory Tract Diseases [C08]

Not yet recruiting

238

Europe

Molgradex 300 mcg nebuliser solution, Nebuliser solution

Justus-Liebig-University Gießen, DZL (Deutsche Zentrum für Lungenforschung)

COVID-19 pneumonia COVID-19-Pneumonie, COVID-19 pneumonia COVID-19-Pneumonie, Diseases [C] - Respiratory Tract Diseases [C08]

GI-HOPE, NCT02595060 / 2014-002479-28: Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) Inhalation to Improve Host Defense and Pulmonary Barrier Restoration

Completed

Europe

inhaled molgramostim (rhGM-CSF), inhaled placebo

University of Giessen

ARDS

09/21

07/22

GI-COVID, NCT04569877: GM-CSF Inhalation to Prevent ARDS in COVID-19 Pneumonia

Completed

Europe

Molgramostim nebuliser solution, Placebo nebuliser solution

University of Giessen

Severe Acute Respiratory Syndrome (SARS) Pneumonia, COVID-19 Pneumonia

06/22

09/22

NCT04823962: Effect of rhGM-CSF on the Healing of Venous Leg Ulcers

Active, not recruiting

Europe

rhGM-CSF + hydrogel, Repogel, Molgramostim, Placebo hydrogel, Standard care

Reponex Pharmaceuticals A/S

Venous Leg Ulcer

12/23

NCT05501340: PD-1 Inhibitor Intraperitoneal Perfusion Combined With PRaG Therapy for Malignant Ascites

Not yet recruiting

1/2

Serplulimab, HLX10, Molgramostim, rhGM-CSF, Hypofractionated radiotherapy/Sterotactic body radiotherapy

Second Affiliated Hospital of Soochow University

Malignant Ascites

12/22

09/24

NCT06546098: Molgramostim Nebulizer Solution Expanded Access Program Protocol

Available

N/A

Molgramostim nebulizer solution, Recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF)

Savara Inc.

Autoimmune Pulmonary Alveolar Proteinosis

amikacin/fosfomycin inhalation (AFIS) / Savara

No trials found

AeroVanc (vancomycin hydrochloride inhalation powder) / Savara

No trials found



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