DDrare: Database of Drug Development for Rare Diseases

Searched query = "Autoimmune pulmonary alveolar proteinosis", "Congenital pulmonary alveolar proteinosis", "Hereditary pulmonary alveolar proteinosis", "Pulmonary alveolar proteinosis", "PAP"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = Device: Centricyte 1000; Diagnostic Test: Abdominal and liver ultrasound.; Diagnostic Test: Brain MRI; Diagnostic Test: Methionine/homocysteine Dosage; Diagnostic Test: Thoracic CT scan; GM-CSF; GM-CSF (granulocyte-macrophage colony-stimulating factor, sargramostim); GM-CSF [Leukine (Sargramostim)]; GM-CSF inhalation therapy; Granulocyte-macrophage colony stimulating factor (GM-CSF); Homocysteine; Leukine; Liberase Enzyme (Roche); MOLGRAMOSTIM; Methionine; Molgramostim; Molgramostim 300 mcg nebuliser solution; Molgramostim Nebuliser solution 300 mcg; Pioglitazone; Procedure: IV Deployment Of cSVF In Sterile Normal Saline IV Solution; Procedure: Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF); Procedure: WLL; Procedure: Whole Lung Lavage(WLL); RhGM-CSF; RhGm-CSF; Rituximab; Sargramostim; Sterile Normal Saline for Intravenous Use; Vitamin B12; Vitamin B12, B9, B6, C supplementation

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2017-004078-32-IT (EUCTR)	16/05/2019	07/01/2019	Clinical trial in patients with the lung disease, autoimmune pulmonary alveolar proteinosis, to assess continued treatment with molgramostim by inhalation	AN OPEN-LABEL, NON-CONTROLLED, MULTICENTRE CLINICAL TRIAL OF INHALED MOLGRAMOSTIM IN AUTOIMMUNE PULMONARY ALVEOLAR PROTEINOSIS PATIENTS - IMPALA-EX	Autoimmune Pulmonary Alveolar Proteinosis (aPAP) MedDRA version: 20.0;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Molgramostim Nebuliser solution 300 mcg INN or Proposed INN: MOLGRAMOSTIM	Savara ApS	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	90	Phase 3	Netherlands;France;Greece;Denmark;Russian Federation;Israel;Germany;United Kingdom;Italy
2	EUCTR2017-004078-32-GR (EUCTR)	05/06/2018	10/05/2018	Clinical trial in patients with the lung disease, autoimmune pulmonary alveolar proteinosis, to assess continued treatment with molgramostim by inhalation	AN OPEN-LABEL, NON-CONTROLLED, MULTICENTRE CLINICAL TRIAL OF INHALED MOLGRAMOSTIM IN AUTOIMMUNE PULMONARY ALVEOLAR PROTEINOSIS PATIENTS - IMPALA-EX	Autoimmune Pulmonary Alveolar Proteinosis (aPAP) MedDRA version: 20.0;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Molgramostim Nebuliser solution 300 mcg INN or Proposed INN: MOLGRAMOSTIM	Savara ApS	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	90	Phase 3	France;Greece;Denmark;Russian Federation;Israel;Netherlands;Germany;Italy;United Kingdom
3	EUCTR2017-004078-32-DE (EUCTR)	30/05/2018	18/12/2017	Clinical trial in patients with the lung disease, autoimmune pulmonary alveolar proteinosis, to assess continued treatment with molgramostim by inhalation	AN OPEN-LABEL, NON-CONTROLLED, MULTICENTRE CLINICAL TRIAL OF INHALED MOLGRAMOSTIM IN AUTOIMMUNE PULMONARY ALVEOLAR PROTEINOSIS PATIENTS - IMPALA-EX	Autoimmune Pulmonary Alveolar Proteinosis (aPAP) MedDRA version: 20.0;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Molgramostim Nebuliser solution 300 mcg INN or Proposed INN: MOLGRAMOSTIM	Savara ApS	NULL	Not Recruiting	Female: yes Male: yes	90	Phase 3	France;Greece;Denmark;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy
4	EUCTR2017-004078-32-FR (EUCTR)	22/03/2018	18/12/2017	Clinical trial in patients with the lung disease, autoimmune pulmonary alveolar proteinosis, to assess continued treatment with molgramostim by inhalation	AN OPEN-LABEL, NON-CONTROLLED, MULTICENTRE CLINICAL TRIAL OF INHALED MOLGRAMOSTIM IN AUTOIMMUNE PULMONARY ALVEOLAR PROTEINOSIS PATIENTS - IMPALA-EX	Autoimmune Pulmonary Alveolar Proteinosis (aPAP) MedDRA version: 20.0;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Molgramostim Nebuliser solution 300 mcg INN or Proposed INN: MOLGRAMOSTIM	Savara ApS	NULL	Not Recruiting	Female: yes Male: yes	90	Phase 3	Denmark;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy;France;Greece

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-004078-32-IT
(EUCTR)

16/05/2019

07/01/2019

Clinical trial in patients with the lung disease, autoimmune pulmonary alveolar proteinosis, to assess continued treatment with molgramostim by inhalation

AN OPEN-LABEL, NON-CONTROLLED, MULTICENTRE CLINICAL TRIAL OF INHALED MOLGRAMOSTIM IN AUTOIMMUNE PULMONARY ALVEOLAR PROTEINOSIS PATIENTS - IMPALA-EX

Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 20.0;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: Molgramostim Nebuliser solution 300 mcg
INN or Proposed INN: MOLGRAMOSTIM

Savara ApS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

Netherlands;France;Greece;Denmark;Russian Federation;Israel;Germany;United Kingdom;Italy

EUCTR2017-004078-32-GR
(EUCTR)

05/06/2018

10/05/2018

Clinical trial in patients with the lung disease, autoimmune pulmonary alveolar proteinosis, to assess continued treatment with molgramostim by inhalation

AN OPEN-LABEL, NON-CONTROLLED, MULTICENTRE CLINICAL TRIAL OF INHALED MOLGRAMOSTIM IN AUTOIMMUNE PULMONARY ALVEOLAR PROTEINOSIS PATIENTS - IMPALA-EX

Product Name: Molgramostim Nebuliser solution 300 mcg
INN or Proposed INN: MOLGRAMOSTIM

Savara ApS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

France;Greece;Denmark;Russian Federation;Israel;Netherlands;Germany;Italy;United Kingdom

EUCTR2017-004078-32-DE
(EUCTR)

30/05/2018

18/12/2017

Clinical trial in patients with the lung disease, autoimmune pulmonary alveolar proteinosis, to assess continued treatment with molgramostim by inhalation

AN OPEN-LABEL, NON-CONTROLLED, MULTICENTRE CLINICAL TRIAL OF INHALED MOLGRAMOSTIM IN AUTOIMMUNE PULMONARY ALVEOLAR PROTEINOSIS PATIENTS - IMPALA-EX

Product Name: Molgramostim Nebuliser solution 300 mcg
INN or Proposed INN: MOLGRAMOSTIM

Savara ApS

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

France;Greece;Denmark;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy

EUCTR2017-004078-32-FR
(EUCTR)

22/03/2018

18/12/2017

Clinical trial in patients with the lung disease, autoimmune pulmonary alveolar proteinosis, to assess continued treatment with molgramostim by inhalation

AN OPEN-LABEL, NON-CONTROLLED, MULTICENTRE CLINICAL TRIAL OF INHALED MOLGRAMOSTIM IN AUTOIMMUNE PULMONARY ALVEOLAR PROTEINOSIS PATIENTS - IMPALA-EX

Product Name: Molgramostim Nebuliser solution 300 mcg
INN or Proposed INN: MOLGRAMOSTIM

Savara ApS

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Denmark;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy;France;Greece