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Clinical trials for Molgramostim

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    11 result(s) found for: Molgramostim. Displaying page 1 of 1.
    EudraCT Number: 2017-004078-32 Sponsor Protocol Number: SAV006-03 Start Date*: 2018-02-06
    Sponsor Name:Savara ApS
    Full Title: AN OPEN-LABEL, NON-CONTROLLED, MULTICENTRE CLINICAL TRIAL OF INHALED MOLGRAMOSTIM IN AUTOIMMUNE PULMONARY ALVEOLAR PROTEINOSIS PATIENTS
    Medical condition: Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10037316 Pulmonary alveolar proteinosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended) NL (Prematurely Ended) DE (Prematurely Ended) FR (Prematurely Ended) GB (GB - no longer in EU/EEA) GR (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-001654-21 Sponsor Protocol Number: KKS-279 Start Date*: 2020-09-16
    Sponsor Name:Justus-Liebig-University Gießen
    Full Title: Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) Inhalation to prevent ARDS in COVID-19 pneumonia
    Medical condition: COVID-19 pneumonia
    Disease: Version SOC Term Classification Code Term Level
    23.1 10021881 - Infections and infestations 10084380 COVID-19 pneumonia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-003878-33 Sponsor Protocol Number: MOL-PAP-002 Start Date*: 2016-01-28
    Sponsor Name:Savara ApS
    Full Title: A Randomised, Double-Blind, Placebo-Controlled Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary AlveoLAr Proteinosis Patients
    Medical condition: Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10037316 Pulmonary alveolar proteinosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DK (Completed) NL (Completed) DE (Completed) GR (Completed) ES (Completed) IT (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2017-003374-14 Sponsor Protocol Number: SAV008-01 Start Date*: 2018-04-06
    Sponsor Name:Savara ApS
    Full Title: An Open-label, non-controlled, multicenter, Pilot clinical Trial of Inhaled Molgramostim in subjects with Antibiotic-resistant non-tuberculosis mycobacterial (NTM) infection
    Medical condition: Treatment-resistant pulmonary non-tuberculosis mycobacterial (NTM) infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10062207 Mycobacterial infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-001263-85 Sponsor Protocol Number: SAV006-05 Start Date*: 2021-07-19
    Sponsor Name:Savara ApS
    Full Title: A randomized, double-blind, placebo-controlled clinical trial of once-daily inhaled molgramostim nebulizer solution in adult subjects with autoimmune pulmonary alveolar proteinosis (aPAP).
    Medical condition: Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004855 10037316 Pulmonary alveolar proteinosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) IE (Trial now transitioned) DE (Ongoing) PL (Trial now transitioned) BE (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing) PT (Trial now transitioned) RO (Trial now transitioned) GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-002479-28 Sponsor Protocol Number: MOL-ARDS-002 Start Date*: 2015-09-24
    Sponsor Name:Justus-Liebig University
    Full Title: GM-CSF Inhalation to improve HOst defense and Pulmonary barrier rEstoration
    Medical condition: Pneumonia associated Acute Respiratory Distress Syndrome (ARDS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10000036 A.R.D.S. LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-000609-10 Sponsor Protocol Number: 2020-01-GMF-1 Start Date*: 2021-07-06
    Sponsor Name:Center for Surgical Science
    Full Title: A combined treatment with GM-CSF, fosfomycin and metronidazole for pouchitis in ulcerative colitis patients after restorative ileal pouch anal anastomosis surgery A clinical safety and proof-of-con...
    Medical condition: A combination of GM-CSF and metronidazole/fosfomycin treatment for pouchitis in Ulcerative Colitis patients after ileal-pouch-anal anastomosis surgery given as an enema or spray in the pouch.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10036463 Pouchitis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-004753-16 Sponsor Protocol Number: HEH-SF-02 Start Date*: 2018-02-01
    Sponsor Name:Department of Surgery, Herlev Hospital
    Full Title: Intraperitoneal administration of fosfomycin, metronidazole and molgramostim versus intravenous conventional antibiotics for perforated appendicitis – a pivotal quasi-randomized controlled trial
    Medical condition: We wish to investigate if intraoperative intraperitoneal administration of fosfomycin, metronidazole and rhGM-CSF followed by oral antibiotic for three days is as effective as the current intraveno...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10000680 Acute appendicitis without mention of peritonitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2015-005772-16 Sponsor Protocol Number: HEH-SF-01 Start Date*: 2016-06-22
    Sponsor Name:Department of Surgery, Herlev Hospital
    Full Title: The safety and pharmacokinetics of intraperitoneal administration of granulocyte-macrophage colony-stimulating factor, fosfomycin, and metronidazole in patients undergoing appendectomy for uncompli...
    Medical condition: We intend to investigate the safety of treating secondary infectious peritonitis due to uncomplicated appendicitis with intraperitoneally administered fosfomycin, metronidazole and GM-CSF.
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004862 10000677 Acute appendicitis LLT
    19.0 100000004848 10053349 Pharmacokinetic study LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2019-001483-30 Sponsor Protocol Number: BBH-GMCSF-01 Start Date*: 2020-06-18
    Sponsor Name:Reponex Pharmaceuticals A/S
    Full Title: Effect of topical rhGM-CSF on the healing of venous leg ulcers: a randomized, placebo-controlled, double-blind, clinical phase II study
    Medical condition: Venous leg ulcers
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004858 10047260 Venous ulceration LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2012-002400-40 Sponsor Protocol Number: CTTG01-01 Start Date*: 2012-11-09
    Sponsor Name:Targovax AS
    Full Title: A Phase I/II Trial of TG01 and Gemcitabine as Adjuvant Therapy for Treating Patients with Resected Adenocarcinoma of the Pancreas
    Medical condition: Adenocarcinoma of the Pancreas
    Disease: Version SOC Term Classification Code Term Level
    15.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033604 Pancreatic cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed) GB (Completed) ES (Prematurely Ended)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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