228. 閉塞性細気管支炎 Bronchiolitis obliterans Clinical trials / Disease details


臨床試験数 : 97 薬物数 : 118 - (DrugBank : 32) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 156

  
36 trials found
No.TrialIDDate_
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2018-003205-25-DK
(EUCTR)
15/02/202228/09/2021Clinical research study to investigate efficacy and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after double lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation - BOSTON-2 Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation
MedDRA version: 20.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Zambon SpANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 3France;United States;Spain;Belgium;Austria;Denmark;Israel;Germany;United Kingdom
2EUCTR2019-002987-29-AT
(EUCTR)
23/04/202021/01/2020Clinical research study to investigate efficacy and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis Obliterans Syndrome after Single or Double Lung Transplantation.An Open Label Follow-Up Study to Evaluate the Long Term Safety and Efficacy of L-CSA in Patients with a Diagnosis of CLAD-BOS after they have completed the participation to BOSTON 1 and BOSTON 2 studies. Bronchiolitis Obliterans Syndrome in Patients post Single or post Double Lung Transplantation
MedDRA version: 20.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Zambon SpANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Phase 3France;United States;Spain;Belgium;Austria;Israel;Germany;United Kingdom
3NCT04039347
(ClinicalTrials.gov)
March 3, 202019/7/2019Open-Label, Extension Trial to Demonstrate the Effectiveness and Safety of L-CsA Plus Standard of Care in the Treatment of BOS in Patients Post Single or Double Lung TransplantA Phase III, Multicenter Open-Label, Extension Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosprine A (L-CsA) Inhalation Solution Delivered Via the PARI Investigational eFlow® Device Plus Standard of Care in the Treatment of Bronchiolitis Obliterans Syndrome in Patients Post Single or Double Lung TransplantationBronchiolitis Obliterans;Obliterative Bronchiolitis;Bronchiolitis Obliterans SyndromeDrug: Liposomal Cyclosporine A 5 mg;Drug: Liposomal Cyclosporine A 10 mgZambon SpANULLEnrolling by invitation18 YearsN/AAll220Phase 3United States;Austria;Belgium;France;Germany;Israel;Spain;United Kingdom
4EUCTR2019-002987-29-ES
(EUCTR)
28/02/202020/12/2019Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis Obliterans Syndrome after Single or Double Lung Transplantation.A Phase III, Multicenter, Open-Label, Extension Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Single or Double Lung Transplantation Bronchiolitis Obliterans Syndrome in Patients post Single or post Double Lung Transplantation
MedDRA version: 20.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
BREATH Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
220 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Belgium;Spain;Austria;Israel;Germany;United Kingdom
5EUCTR2019-002987-29-DE
(EUCTR)
12/02/202026/11/2019Clinical research study to investigate efficacy and safety of LiposomalCyclosporine A (L-CsA) in patients with Bronchiolitis Obliterans Syndromeafter Single or Double Lung Transplantation.An Open Label Follow-Up Study to Evaluate the Long Term Safety andEfficacy of L-CSA in Patients with a Diagnosis of CLAD-BOS after they havecompleted the participation to BOSTON 1 and BOSTON 2 studies. Bronchiolitis Obliterans Syndrome in Patients post Single or post Double Lung Transplantation
MedDRA version: 20.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Zambon SpANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Phase 3France;United States;Spain;Belgium;Austria;Israel;Germany;United Kingdom
6EUCTR2019-002987-29-FR
(EUCTR)
23/01/202023/01/2020Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis Obliterans Syndrome after Single or Double Lung Transplantation.A Phase III, Multicenter, Open-Label, Extension Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Single or Double Lung Transplantation - BOSTON-3 Bronchiolitis Obliterans Syndrome in Patients post Single or post Double Lung Transplantation
MedDRA version: 20.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
BREATH Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Phase 3United States;France;Spain;Belgium;Austria;Israel;Germany;United Kingdom
7EUCTR2019-000718-13-DE
(EUCTR)
17/12/201906/06/2019A Clinical Research Study to Investigate the Safety and Tolerability ofinhaled Liposomal Cyclosporine A (L-CsA) in Patients with BronchiolitisObliterans Syndrome after Allogeneic Hematopoietic Stem CellTransplantation.BOSTON-4: A Phase IIa Multi-Center, Randomized, Single-Blind Safety andTolerability Study of inhaled Liposomal Cyclosporine A in BronchiolitisObliterans Syndrome Following Allogeneic Hematopoietic Stem CellTransplantation - BOSTON-4 Bronchiolitis Obliterans Syndrome in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Zambon SpANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 2France;Spain;Germany
8EUCTR2019-000718-13-FR
(EUCTR)
03/12/201925/11/2019A Clinical Research Study to Investigate the Safety of Liposomal Cyclosporine A (L-CsA) in Patients with Bronchiolitis Obliterans Syndrome after Allogeneic Hematopoietic Stem Cell Transplantation.A Phase IIa Multi-Center, Randomized, Single-Blind Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Stem Cell Transplantation. - BOSTON-4 Bronchiolitis Obliterans Syndrome in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Breath Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 2France;Spain;Germany
9EUCTR2019-000718-13-ES
(EUCTR)
27/11/201905/11/2019A Clinical Research Study to Investigate the Safety of Liposomal Cyclosporine A (L-CsA) in Patients with Bronchiolitis Obliterans Syndrome after Allogeneic Hematopoietic Stem Cell Transplantation.A Phase IIa Multi-Center, Randomized, Single-Blind Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Stem Cell Transplantation. - BOSTON-4 Bronchiolitis Obliterans Syndrome in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Breath Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
24 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSpain
10EUCTR2018-003204-39-GB
(EUCTR)
21/10/201914/01/2019Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after single lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation - BOSTON-1 Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
BREATH Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;France;Spain;Israel;Germany;United Kingdom
11EUCTR2018-003205-25-GB
(EUCTR)
11/09/201914/01/2019Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after double lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation - BOSTON-2 Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
BREATH Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 3United States;France;Spain;Belgium;Austria;Israel;Germany;United Kingdom
12EUCTR2018-003205-25-AT
(EUCTR)
02/04/201904/12/2018Clinical research study to investigate efficacy and safety of LiposomalCyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndromeafter double lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trialto Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A (LCsA)Inhalation Solution Delivered via the PARI Investigational eFlow®Device plus Standard of Care versus Standard of Care Alone in theTreatment of Chronic Lung Allograft Dysfunction / Bronchiolitis ObliteransSyndrome in Patients post Double Lung Transplantation - BOSTON-2 Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndromein Patients post Single Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Zambon SpANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
152Phase 3United States;France;Spain;Belgium;Austria;Israel;Germany;United Kingdom
13NCT03656926
(ClinicalTrials.gov)
March 29, 201930/8/2018A Clinical Trial to Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A Inhalation Solution in the Treatment of CLAD/Bronchiolitis Obliterans Syndrome in Patients Post Double Lung TransplantA Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered Via the PARI Investigational eFlow® Device Plus Standard of Care Versus Standard of Care Alone in the Treatment of Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndrome in Patients Post Double Lung TransplantationBronchiolitis Obliterans;Chronic Rejection of Lung Transplant;Lung Transplant Rejection;Lung Transplant; Complications;Lung Transplant Failure and Rejection;Chronic Lung Allograft DysfunctionDrug: Liposomal Cyclosporine AZambon SpANULLRecruiting18 YearsN/AAll110Phase 3United States;Austria;Belgium;France;Germany;Israel;Spain;United Kingdom
14NCT03657342
(ClinicalTrials.gov)
March 26, 201930/8/2018A Clinical Trial to Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A Inhalation Solution in the Treatment of CLAD/Bronchiolitis Obliterans Syndrome in Patients Post Single Lung TransplantA Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered Via the PARI Investigational eFlow® Device Plus Standard of Care Versus Standard of Care Alone in the Treatment of Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndrome in Patients Post Single Lung TransplantationBronchiolitis Obliterans;Chronic Rejection of Lung Transplant;Lung Transplant Rejection;Lung Transplant; Complications;Lung Transplant Failure and Rejection;Chronic Lung Allograft DysfunctionDrug: Liposomal Cyclosporine AZambon SpANULLRecruiting18 YearsN/AAll110Phase 3United States;France;Germany;Israel;Spain;United Kingdom
15EUCTR2018-003205-25-DE
(EUCTR)
04/03/201915/11/2018Clinical research study to investigate efficacy and safety of LiposomalCyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndromeafter double lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trialto Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A (LCsA)Inhalation Solution Delivered via the PARI Investigational eFlow®Device plus Standard of Care versus Standard of Care Alone in theTreatment of Chronic Lung Allograft Dysfunction / Bronchiolitis ObliteransSyndrome in Patients post Double Lung Transplantation - BOSTON-2 Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndromein Patients post Single Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Zambon SpANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 3France;United States;Spain;Belgium;Austria;Israel;Germany;United Kingdom
16EUCTR2018-003205-25-ES
(EUCTR)
01/03/201918/01/2019Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after double lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation - BOSTON-2 Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
BREATH Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
110 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Belgium;Spain;Austria;Israel;Germany;United Kingdom
17EUCTR2018-003204-39-DE
(EUCTR)
20/02/201915/11/2018Clinical research study to investigate efficacy and safety of LiposomalCyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndromeafter single lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trialto Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A (LCsA)Inhalation Solution Delivered via the PARI Investigational eFlow®Device plus Standard of Care versus Standard of Care Alone in theTreatment of Chronic Lung Allograft Dysfunction / Bronchiolitis ObliteransSyndrome in Patients post Single Lung Transplantation - BOSTON-1 Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndromein Patients post Single Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
ZAMBON SpANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3France;United States;Spain;Israel;Germany;United Kingdom
18EUCTR2018-003204-39-ES
(EUCTR)
08/02/201918/01/2019Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after single lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation - BOSTON-1 Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
BREATH Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Spain;Israel;Germany;United Kingdom
19EUCTR2018-003204-39-FR
(EUCTR)
09/01/201913/11/2018Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after single lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation - BOSTON-1 Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
BREATH Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;France;Spain;Israel;Germany;United Kingdom
20EUCTR2011-004304-38-ES
(EUCTR)
19/09/201222/06/2012An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsAA long-term safety follow-up study of L-CsA therapy for patients who participated in study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy - Not applicable Prevention of Bronchiolitis Obliterans Syndrome in lung transplant
MedDRA version: 14.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Aerolised Liposomal Ciclosporin A 5mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A 10mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
180France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom
21NCT01650545
(ClinicalTrials.gov)
July 201227/6/2012Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant RecipientsA Pilot Study to Demonstrate Efficacy and Safety of Aerosol Liposomal Cyclosporine (L-CsA) in the Treatment of Bronchiolitis Obliterans Syndrome After Lung TransplantationDisorder Related to Lung Transplantation;Bronchiolitis Obliterans;Decreased Immunologic Activity;Chronic Rejection of Lung TransplantDrug: Liposomal aerosol cyclosporine;Other: standard immune suppression, oralUniversity of Maryland, College ParkNULLCompleted18 YearsN/AAll21Phase 1/Phase 2United States
22EUCTR2011-004304-38-GB
(EUCTR)
14/06/201209/12/2011An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsAA long-term safety follow-up study of L-CsA therapy for patients who participated in study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy - Not applicable Prevention of Bronchiolitis Obliterans Syndrome in lung transplant
MedDRA version: 14.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Aerolised Liposomal Ciclosporin A 5mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A 10mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom
23EUCTR2011-004304-38-AT
(EUCTR)
13/03/201220/12/2011An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsAA long-term safety follow-up study of L-CsA therapy for patients who participated in study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy Prevention of Bronchiolitis Obliterans Syndrome in lung transplant
MedDRA version: 15.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Aerolised Liposomal Ciclosporin A 5mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A 10mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
180France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom
24EUCTR2011-004304-38-BE
(EUCTR)
14/02/201215/12/2011An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsAA long-term safety follow-up study of L-CsA therapy for patients who participated in study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy - Not applicable Prevention of Bronchiolitis Obliterans Syndrome in lung transplant
MedDRA version: 14.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Aerolised Liposomal Ciclosporin A 5mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A 10mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3France;Canada;Spain;Belgium;Denmark;Austria;Germany;United Kingdom
25NCT01439958
(ClinicalTrials.gov)
February 201222/9/2011Long-term Safety Follow-up Study in the Prevention of Bronchiolitis Obliterans Syndrome (BOS)A Long-term Safety Follow-up Study of L-CsA Therapy for Patients Who Participated in Study 12011.201 and Volunteered to Continue or to Cross-over to L-CsA Inhalation TherapyBronchiolitis ObliteransDrug: InhalationPari Pharma GmbHNULLTerminated18 Years80 YearsBoth14Phase 3Germany
26EUCTR2011-004304-38-DK
(EUCTR)
20/01/201219/12/2011An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsAA long-term safety follow-up study of L-CsA therapy for patients who participated in study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy - Not applicable Prevention of Bronchiolitis Obliterans Syndrome in lung transplant
MedDRA version: 14.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Aerolised Liposomal Ciclosporin A 5mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A 10mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3France;Canada;Belgium;Spain;Austria;Denmark;Germany;United Kingdom
27EUCTR2011-004304-38-DE
(EUCTR)
06/01/201228/11/2011An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsAA long-term safety follow-up study of L-CsA therapy for patients who participated in study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy Prevention of Bronchiolitis Obliterans Syndrome in lung transplant
MedDRA version: 14.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Aerolised Liposomal Ciclosporin A 5mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A 10mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
40France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom
28EUCTR2008-003800-73-BE
(EUCTR)
14/09/201008/01/2009A clinical trial to investigate whether a dose of 10mg or 20mg aerolised liposomal ciclosporin A (L-CsA) is safe and effective to prevent Bronchiolitis Obliterans Syndrome (BOS) in lung transplane patientsA phase III, multicentre, randomised, double-blind, placebo controlled clinical trial to investigate the efficacy and safety of 10 or 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients Prevention of bronchiolitis obliterans syndrome in lung transplant
MedDRA version: 15.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Canada;Spain;Belgium;Denmark;Austria;Germany;United Kingdom
29EUCTR2008-003800-73-ES
(EUCTR)
22/07/201026/05/2010A phase II, multicentre,randomised, double-blind, placebo controlled, parallel group, dose-finding clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patientsEnsayo clínico de fase II, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y búsqueda de dosis para investigar la eficacia y la seguridad de 10 y 20 mg/día de Ciclosporina A Liposómica aerosolizada (L-CsA) frente a placebo aerosolizado en la prevención del síndrome de bronquiolitis obliterante (SBO) en pacientes con trasplante pulmonarA phase II, multicentre,randomised, double-blind, placebo controlled, parallel group, dose-finding clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patientsEnsayo clínico de fase II, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y búsqueda de dosis para investigar la eficacia y la seguridad de 10 y 20 mg/día de Ciclosporina A Liposómica aerosolizada (L-CsA) frente a placebo aerosolizado en la prevención del síndrome de bronquiolitis obliterante (SBO) en pacientes con trasplante pulmonar Prevention of bronchiolitis obliterans syndrome in lung transplantPrevención del sindrome de bronquiolitis obliterante en transplante pulmonar
MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans
Product Name: Ciclosporina A Liposomica Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporina/ Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Ciclosporina A Liposomica Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporina / Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Solucion de cloruro de sodio Sodium Chloride Solution
Product Code: Solvente Cloruro de Sodio Sodium Chloride Solvent
Other descriptive name: Cloruro de sodio
Product Name: Solucion de Cloruro de Sodio
Product Code: Solvente de Cloruro de Sodio
Other descriptive name: Cloruro de Sodio
Pari Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
134Phase 2Belgium;Spain;Denmark;Austria;Germany;United Kingdom
30EUCTR2008-003800-73-DK
(EUCTR)
13/04/201018/08/2009A phase II, multicentre,randomised, double-blind, placebo controlled, parallel group, dose-finding clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patientsA phase II, multicentre,randomised, double-blind, placebo controlled, parallel group, dose-finding clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients Prevention of bronchiolitis obliterans syndrome in lung transplant
MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
Pari Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
134Phase 2Spain;Belgium;Austria;Denmark;Germany;United Kingdom
31NCT01334892
(ClinicalTrials.gov)
December 200911/4/2011L-CsA in the Prevention of Bronchiolitis Obliterans Syndrome (BOS) in Lung Transplant (LT) PatientsA Phase II, Multicentre, Randomised, Double-blind, Placebo Controlled Clinical Trial to Investigate the Efficacy and Safety of Aerosolised Liposomal Ciclosporin A Versus Aerosolised Placebo in the Prevention of Bronchiolitis Obliterans Syndrome in Lung Transplant PatientsBronchiolitis ObliteransDrug: Cyclosporine Inhalation SolutionPari Pharma GmbHNULLTerminated18 YearsN/ABoth130Phase 2/Phase 3Germany
32EUCTR2008-003800-73-GB
(EUCTR)
27/08/200907/01/2009A phase II, multicentre, randomised, double-blind, placebo controlled, clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patientsA phase II, multicentre, randomised, double-blind, placebo controlled, clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients Prevention of bronchiolitis obliterans syndrome in lung transplant
MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Pari Pharma GmbHNULLNot Recruiting Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSpain;Belgium;Denmark;Austria;Germany;United Kingdom
33EUCTR2008-003800-73-DE
(EUCTR)
14/07/200929/12/2008A clinical trial to investigate whether a dose of 10mg or 20mg aerolised liposomal ciclosporin A (L-CsA) is safe and effective to prevent Bronchiolitis Obliterans Syndrome (BOS) in lung transplane patientsA phase II, multicentre, randomised, double-blind, placebo controlled clinical trial to investigate the efficacy and safety of 10 or 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients Prevention of bronchiolitis obliterans syndrome in lung transplant
MedDRA version: 14.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom
34EUCTR2008-003800-73-AT
(EUCTR)
08/07/200911/05/2009A clinical trial to investigate whether a dose of 10mg or 20mg aerolised liposomal ciclosporin A (L-CsA) is safe and effective to prevent Bronchiolitis Obliterans Syndrome (BOS) in lung transplane patientsA phase III, multicentre, randomised, double-blind, placebo controlled clinical trial to investigate the efficacy and safety of 10 or 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients Prevention of bronchiolitis obliterans syndrome in lung transplant
MedDRA version: 14.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Canada;Spain;Belgium;Denmark;Austria;Germany;United Kingdom
35EUCTR2008-003801-15-GB
(EUCTR)
26/02/200924/11/2010A phase II, randomised, double-blind, placebo controlled, parallel group,dose-finding clinical trial to investigate the efficacy and safety of 10 and 20mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in thetreatment of bronchiolitis obliterans syndrome (BOS) in allogeneichaematopoietic stem cell transplant (HSCT) patientsA phase II, randomised, double-blind, placebo controlled, parallel group,dose-finding clinical trial to investigate the efficacy and safety of 10 and 20mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in thetreatment of bronchiolitis obliterans syndrome (BOS) in allogeneichaematopoietic stem cell transplant (HSCT) patients Bronchiolitis Obliterans Syndrome
MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, ciclosporina
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride solvent
Other descriptive name: Sodium Chloride
PARIPharma GmbHNULLNot RecruitingFemale: yes
Male: yes
70Phase 2United Kingdom
36EUCTR2008-003801-15-BE
(EUCTR)
08/01/2009A phase II, randomised, double-blind, placebo controlled, parallel group,dose-finding clinical trial to investigate the efficacy and safety of 10 and 20mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in thetreatment of bronchiolitis obliterans syndrome (BOS) in allogeneichaematopoietic stem cell transplant (HSCT) patientsA phase II, randomised, double-blind, placebo controlled, parallel group,dose-finding clinical trial to investigate the efficacy and safety of 10 and 20mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in thetreatment of bronchiolitis obliterans syndrome (BOS) in allogeneichaematopoietic stem cell transplant (HSCT) patients Bronchiolitis Obliterans Syndrome
MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, ciclosporina
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride solvent
Other descriptive name: Sodium Chloride
PARIPharma GmbHNULLNot RecruitingFemale: yes
Male: yes
70Phase 2Belgium;United Kingdom