Organization
Chiesi Farmaceutici
35 clinical trials
Clinical trial
A Real-world Analysis of Pharmacodynamic Response to Velmanase Alfa (Lamzede®) Treatment in Patients With Alpha-Mannosidosis Less Than 3 Years of AgeStatus: Not yet recruiting, Estimated PCD: 2029-09-01
Clinical trial
Evaluation of the Absolute Bioavailability and Mass Balance of CHF6001 Following a Single Inhaled Dose Co-administered With an Intravenous Radiolabelled Microtracer Dose in Healthy VolunteersStatus: Completed, Estimated PCD: 2021-04-29
Clinical trial
A Multicenter Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Pegunigalsidase Alfa (PRX-102) in Japanese Patients With Fabry Disease (RISE)Status: Recruiting, Estimated PCD: 2026-03-01
Clinical trial
Multi-centre, Open-label Trial to Assess the saFety, Pharmacodynamics, Efficacy and Pharmacokinetics of pegunigaLsidase Alfa in Patients From 2 Years to Less Than 18 Years of Age With Confirmed FabrY DiseaseStatus: Not yet recruiting, Estimated PCD: 2027-12-01
Clinical trial
A 12-week Double-blind, Multicentre, Randomised, Active-controlled, 2-arm, Parallel-group Clinical Trial to Evaluate the Safety of CHF5993 pMDI 200/6/12.5 μg HFA-152a, Compared to CHF5993 pMDI 200/6/12.5 μg HFA-134a, in Subjects With Asthma.Status: Recruiting, Estimated PCD: 2024-08-25
Clinical trial
A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Inhaled CHF6333 After Single Ascending Doses in Healthy Volunteers and One Single Dose in Adult Subjects With Bronchiectasis, Followed by a Placebo-controlled, Repeated Dose, 3-way Cross-over in Adult Subjects With BronchiectasisStatus: Recruiting, Estimated PCD: 2025-06-01
Clinical trial
A 12 Week, Randomized, Double-blind, Multicenter, Active Controlled, 2-Arm Parallel Group Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose (Fixed Combination of Extrafine Beclomethasone Dipropionate Plus Formoterol Fumarate) Compared to CHF 718 pMDI 800µg Total Daily Dose (Extrafine Beclomethasone Dipropionate) in Adults With Asthma on Medium or High-Dose Inhaled CorticosteroidStatus: Active (not recruiting), Estimated PCD: 2024-06-01
Clinical trial
A 26 Week, Randomized, Double Blind, Multinational, Multicenter, Active Controlled, 2-arm Parallel Group Trial Comparing CHF 5993 100/6/12.5 μg pMDI (Fixed Combination of Extrafine Formulation of Beclometasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide) to CHF 1535 200/6 μg pMDI (Fixed Combination of Extrafine Formulation of Beclometasone Dipropionate Plus Formoterol Fumarate) in Subjects With Asthma Uncontrolled on Medium Doses of Inhaled Corticosteroids in Combination With Long-Acting β2-Agonists.Status: Active (not recruiting), Estimated PCD: 2024-04-01
Clinical trial
PhIb, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, and PK of an i.v. mAb After Single Ascending Doses in Subjects Affected by Idiopathic Pulmonary Fibrosis.Status: Active (not recruiting), Estimated PCD: 2024-06-25
Clinical trial
Open Label Study to Assess the Efficacy, Safety and Dosing of Clevidipine in Pediatric Patients Undergoing SurgeryStatus: Withdrawn, Estimated PCD: 2024-02-20
Clinical trial
A Phase III, 52-week, Multinational, Multicenter, Randomized, Double-blind, 2-arm Parallel Group Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide (CHF 5993) With the Fixed Dose Dual Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate (CHF 1535), Both Administered Via pMDI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)Status: Recruiting, Estimated PCD: 2024-12-01
Clinical trial
Open-label, Non-randomised, Parallel-group Study to Investigate the Pharmacokinetics, Safety and Tolerability Following Single Administration of CHF6001 in Subjects With Mild, Moderate and Severe Liver Impairment in Comparison With Matched Healthy Control SubjectsStatus: Completed, Estimated PCD: 2022-11-25
Clinical trial
A 52-week, Randomized, Double-blind, Double-dummy, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg), Parallel Group, Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI add-on to Maintenance Triple Therapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis.Status: Recruiting, Estimated PCD: 2027-09-11
Clinical trial
Multicenter, Open-label, Randomised Trial to Assess the Efficacy and Tolerability of Poractant Alfa(Porcine Surfactant, Curosurf®) in Hospitalized Patients With SARS-COV-19 Acute Respiratory Distress Syndrome (ARDS)Status: Terminated, Estimated PCD: 2022-03-17
Clinical trial
A 52-week, Randomised, Double Blind, Multicentre, 2-arm Parallel Group Trial Assessing Efficacy of CHF6001 (Total Daily Dose 3200μg) Dry Powder Inhaler (DPI) add-on to Maintenance Medium or High Dose of Inhaled Corticosteroids in Combination With Long-acting ß2-agonists in Subjects With Uncontrolled AsthmaStatus: Recruiting, Estimated PCD: 2025-12-18
Clinical trial
A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of CHF 6523 After Single or Multiple Ascending Doses in Healthy Subjects, Followed by a Placebo Controlled Repeated Dose 2-way Crossover in COPD SubjectsStatus: Completed, Estimated PCD: 2022-12-05
Clinical trial
A Double Blind, Multicentre, Randomised, Placebo-Controlled, 3-Way Cross-Over Study To Evaluate The Effect Of A Triple Combination Of Beclometasone Dipropionate And Formoterol Fumarate Plus Glycopyrronium (CHF5993) And A Dual Combination Of Beclometasone Dipropionate Plus Formoterol Fumarate (CHF1535) Both Administered Via pMDI On Lung Hyperinflation And Exercise Endurance Time In Subjects With Chronic Obstructive Pulmonary Disease (COPD)Status: Completed, Estimated PCD: 2023-02-24
Clinical trial
Single Arm, Open-Label, Multicenter, Registry Study of Revcovi (Elapegademase-lvlr) Treatment in ADA-SCID Patients Requiring Enzyme Replacement TherapyStatus: Completed, Estimated PCD: 2023-01-18
Clinical trial
A Single-dose, Randomised, Double-blind, Controlled, 2-way Cross-over Study to Assess the Potential for Bronchoconstriction of the New Propellant HFA-152a Versus the Marketed HFA-134a Propellant, in Adult Subjects With Mild AsthmaStatus: Completed, Estimated PCD: 2022-10-31
Clinical trial
Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa (PRX-102) in Patients With Fabry DiseaseStatus: Active (not recruiting), Estimated PCD: 2025-01-01
Clinical trial
Expanded Access Treatment With Open-Label Pegunigalsidase Alfa for Fabry PatientsStatus:
Clinical trial
A Multi-center, Un-controlled, Open-labeled Trial of the Long-term Safety of Lamazym Aftercare Treatment of Subjects With Alpha-Mannosidosis Whom Previously Participated in Lamazym TrialsStatus: Completed, Estimated PCD: 2022-09-30
Clinical trial
A 52-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI add-on to Maintenance Triple Therapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD) and Chronic BronchitisStatus: Recruiting, Estimated PCD: 2025-06-13
Clinical trial
Open-label, Non-randomised, Parallel-group Study to Investigate the Pharmacokinetics, Safety and Tolerability Following Single Administration of CHF6001 in Subjects With Mild, Moderate and Severe Renal Impairment in Comparison With Matched Healthy Control SubjectsStatus: Completed, Estimated PCD: 2022-12-27
Clinical trial
Open Label Extension Study to Evaluate the Long-term Safety and Efficacy of 2 mg/kg Pegunigalsidase Alfa (PRX-102) Administered by Intravenous Infusion Every 4 Weeks in Adult Patients With Fabry DiseaseStatus: Active (not recruiting), Estimated PCD: 2024-09-01
Clinical trial
A Single-center, Un-controlled, Open-labeled Trial of the Long-term Safety of Lamazym Aftercare Treatment of Subjects With Alpha-Mannosidosis Whom Previously Participated in Lamazym TrialsStatus: Completed, Estimated PCD: 2022-09-30
Clinical trial
A Prospective, Open-Label, Single-Arm, Multi-Center Study To Assess The Pharmacokinetics/Pharmacodynamics (PK/PD) And Safety Of Different Cangrelor Doses In Neonatal Subjects At Risk Of ThrombosisStatus: Completed, Estimated PCD: 2019-08-31
Clinical trial
A Randomized, Double-blind, Positive and Placebo-controlled, Single-dose, Crossover Study of the Effects of CHF5993 pMDI (BDP/FF/GB) at the Proposed Therapeutic and Supratherapeutic Doses, on the Cardiovascular Safety in Healthy SubjectsStatus: Completed, Estimated PCD: 2023-10-13
Clinical trial
A Single Dose, Randomized, Open-label, 3-Way Cross-over Clinical Pharmacology Study, to Evaluate the Systemic Exposure of BDP, Beclomethasone 17-monoproprionate, Formoterol Fumarate, and Glycopyrronium Bromide, After Inhalation of the Fixed Combination BDP/FF/GB HFA pMDI (CHF 5993) at Two Different Strengths and of BDP Hydrofluoroalkane (HFA), in Healthy Volunteers.Status: Recruiting, Estimated PCD: 2023-08-03
Clinical trial
A Phase II, Multicenter, Double Blind, Double Dummy, Randomized, 2 Arms Parallel Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CHF6563 in Babies With Neonatal Opioid Withdrawal SyndromeStatus: Terminated, Estimated PCD: 2021-12-13
Clinical trial
An Open-Label, Multicenter, Randomized, Controlled Study in Spontaneously Breathing Preterm Neonates With Respiratory Distress Syndrome to Compare Two Procedures for Porcine Surfactant (Poractant Alfa, CUROSURF®) Administration: A Less Invasive Method (LISA) During Non-invasive Ventilation (NIV) and the Conventional Administration During Brief Invasive Ventilation.Status: Terminated, Estimated PCD: 2022-08-13
Clinical trial
A Phase 3, Randomized, Double-Blind, Active and Placebo-Controlled Study on the Use of CUSA-081 for Dysfunctional Central Venous Access Devices (CVADs)Status: Terminated, Estimated PCD: 2023-06-08
Clinical trial
A 12-week, Multicenter, Randomized, Double-blind, Double-dummy, 2-arm Parallel Group Study Comparing the Efficacy and Safety of Foster 100/6mg NEXThaler, 2 Inhalations b.i.d, Versus Foster 100/6mg pMDI, 2 Puffs b.i.d in Patients With Controlled AsthmaStatus: Completed, Estimated PCD: 2021-12-28
Clinical trial
Open-label, Non-randomised, One-sequence Crossover Study to Investigate the Effect of Inhibition of CYP3A4/5 by Erythromycin on the Pharmacokinetics of CHF6001 in Healthy SubjectsStatus: Recruiting, Estimated PCD: 2024-07-27