Clinical trials: sponsored by Chiesi Farmaceutici S.p.A.
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
A Thorough QT (TQT) Study of CHF5993 pMDI in Healthy Volunteers (HV)
The purpose of this study is to evaluate the potential for cardiac repolarization, according to electrocardiographic monitoring (including QT and QTc intervals), of two dose levels of CHF5993 pMDI (beclomethasone…
- Trial name
- NCT05830071
- Testing
- CHF5993, CHF5259, Moxifloxacin 400mg
- Where
- United States
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Catheter Occlusion, Thrombosis
Efficacy and Safety of CUSA-081 in the Restoration of Central Venous Access Device (CVAD) Functionality
To evaluate the efficacy and safety of CUSA-081 (diluted reteplase) in the restoration of central venous access device (CVAD) functionality in participants 18 years and older.
- Trial name
- READY1 (NCT03594175)
- Testing
- CUSA-081, Alteplase
- Where
- 77 sites in United States, Argentina and 5 more
- Volunteers
- 462 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Fabry Disease
Open-Label Expanded Access Treatment With Pegunigalsidase Alfa for Fabry Disease Patients
The objective of this treatment protocol is to provide guidance to Treating Physicians who seek access to pegunigalsidase alfa for Fabry patients whose clinical condition, in the opinion of the Treating Physician, requires…
- Trial name
- NCT04552691
- Testing
- Pegunigalsidase Alfa
- Where
- 11 sites in United States
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease
Effect of Erythromycin on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers
The objective of this study is to investigate the effect of the interaction of Erythromycin (CYP3A4/5 moderate inhibitor) on the pharmacokinetic of CHF6001 (CYP3A4/5 substrate) in Healthy Volunteers.
- Trial name
- NCT06395610
- Testing
- CHF6001 DPI, Erythromycin
- Where
- Bulgaria
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease
Clinical 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 Subjects
A clinical trial to investigate the pharmacokinetics, safety and tolerability of CHF6001 after single administrations in participants with mild, moderate and severe liver impairment with matched healthy adult volunteers
- Trial name
- NCT05373953
- Testing
- CHF6001
- Where
- Bulgaria
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease (COPD), COPD
Evaluation of the Absolute Bioavailability and Mass Balance of CHF6001 (Tanimilast) in Healthy Subjects
The objective of the study is to evaluate the bioavailability of CHF6001 after inhaled administration, to characterize the mass balance and route of elimination of CHF6001 along with its relevant metabolites, in healthy male…
- Trial name
- NCT04756960
- Testing
- CHF6001
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Respiratory Distress Syndrome (RDS)
A Study in Preterm Neonates With Respiratory Distress Syndrome (RDS) Comparing CUROSURF® Administration Through Less Invasive Surfactant Administration (LISA) and Conventional Administration
This study compared the administration of porcine surfactant (poractant alfa, Curosurf®) through a less invasive method (LISA), using a thin catheter, CHF 6440 (LISACATH®), during non-invasive ventilation (CPAP, NIPPV, BiPAP)…
- Trial name
- LISPAP (NCT02772081)
- Testing
- LISA combination product (Curosurf+catheter CHF6440), Curosurf through conventional administration (endotracheal tube)
- Where
- 26 sites in United States
- Volunteers
- 33 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Alpha-Mannosidosis
Expanded Access to Velmanase Alfa
Individual patient expanded access requests may be considered for patients who have no other treatment options.
- Trial name
- NCT04959240
- Testing
- Velmanase Alfa
- Sponsor
- Chiesi Farmaceutici S.p.A.
Neonatal Opioid Withdrawal Syndrome
CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome
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 Syndrome
- Trial name
- NOWSHINE (NCT04104646)
- Testing
- CHF6563, Morphine
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Alpha-Mannosidosis
Lamazym Aftercare Study FR Designed to Provide Treatment for French Patients
The overall objective of this trial is to provide aftercare treatment with Lamazym and to evaluate the safety of repeated Lamzede i.v. treatment of subjects with alpha-Mannosidosis.
- Trial name
- rhLAMAN-07 (NCT01908712)
- Testing
- Lamazym
- Where
- France
- Volunteers
- 13 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Alpha-Mannosidosis
Lamazym Aftercare Study
The overall objective of this trial is to provide aftercare treatment with Lamazym and to evaluate the safety of repeated Lamazym i.v. treatment of subjects with alpha-Mannosidosis whom previously participated in Lamazym-trial.
- Trial name
- rhLAMAN-09 (NCT01908725)
- Testing
- Lamazym
- Where
- Denmark
- Volunteers
- 8 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Acute Respiratory Distress Syndrome
Poractant Alfa (Curosurf®)) -- Effect in Adult Patients Diagnosed With 2019 Novel Coronavirus (SARS-COV-19; (Covid-19)) Acute Respiratory Distress Syndrome (ARDS)
The purpose of this study was to evaluate the efficacy and safety of poractant alfa (Curosurf®), administered by endotracheal (ET) instillation in hospitalized adult patients diagnosed with SARS-COV-19 acute respiratory distress…
- Trial name
- NCT04502433
- Testing
- CUROSURF® (poractant alfa)
- Where
- 6 sites in United States, Italy and 1 more
- Volunteers
- 22 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease
CHF5993 and CHF1535 pMDI on Lung Hyperinflation and Exercise Endurance Time in Subjects With COPD
Double Blind, Multinational, 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)…
- Trial name
- TRIFORCE (NCT05097014)
- Testing
- CHF5993, CHF1535
- Where
- Germany
- Volunteers
- 106 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Fabry Disease
Fabry Patient's Experience Of PegunigaLsidasE Alfa Monthly Infusion
Pegunigalsidase alfa (PRX-102) is a long-term enzyme replacement therapy design for the treatment of patients with Fabry disease.
- Trial name
- PEOPLE (NCT05186324)
- Testing
- Interview
- Where
- 12 sites in United States, Belgium and 3 more
- Volunteers
- 23 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Partial Obstruction of Systemic to Pulmonary Artery Shunt, Complete Obstruction of Systemic to Pulmonary Artery Shunt
Cangrelor Neonatal PK/PD and Safety Study
The purpose of this study is to assess the PK/PD and safety profile of cangrelor in neonatal participants at risk of thrombosis.
- Trial name
- NCT02765633
- Testing
- Cangrelor
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease
PK of CHF6001 in Subjects With Mild, Moderate and Severe Renal Impairment vs. Healthy Volunteers
The purpose of the study is to obtain pharmacokinetics, safety and tolerability data after single administrations of CHF6001 in subjects with mild, moderate and severe renal impairment as well as healthy volunteers under the same…
- Trial name
- NCT05431426
- Testing
- CH6001
- Where
- Bulgaria
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
Study on Patterns of Care in Mild Asthmatic Patients
The PRIME study is an observational, Real World Evidence study designed to collect the type of treatments that are currently prescribed to patients with mild asthma and to collect relevant clinical data that could reflect the…
- Trial name
- PRIME (NCT04598555)
- Where
- 59 sites in Germany, Italy and 2 more
- Volunteers
- 981 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease, Asthma
Lung Deposition of TRIMBOW® pMDI in Healthy Volunteers, Asthmatic and COPD Patients
The purpose of this study is to investigate the lung deposition and distribution pattern of TRIMBOW using a Gamma-scintigraphic technique after inhalation of a single dose of 99mTc radiolabelled TRIMBOW administered via pMDI in…
- Trial name
- STORM (NCT03795350)
- Testing
- Beclometasone dipropionate Formoterol Fumarate Glycopyrronium Bromide
- Where
- United Kingdom
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Kidney Transplant
The Adherence of Immunosuppressive Therapy Including Tacrolimus Once-daily in Italian Kidney Transplant Recipients
Non-adherence is widespread in the transplant community. Addressing issues associated with non-adherence remains a key challenge in transplantation, in part due to the difficulty in assessing its prevalence, as there is currently…
- Trial name
- NCT03558373
- Testing
- Immunosuppressive
- Where
- 12 sites in Italy
- Volunteers
- 158 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Restoration of Function to CVADs
Efficacy and Safety of CUSA-081 in the Restoration of Dysfunctional Central Venous Access Device (CVAD) Functionality
Study to evaluate the efficacy and safety of CUSA-081 in the restoration of central venous access device (CVAD) functionality in participants 12 years and older.
- Trial name
- READY 2 (NCT03992443)
- Testing
- CUSA-081
- Where
- 15 sites in United States, Bulgaria and 1 more
- Sponsor
- Chiesi Farmaceutici S.p.A.