Clinical trials: sponsored by Chiesi Farmaceutici S.p.A.
- Lead sponsor (exact) Chiesi Farmaceutici S.p.A.
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Asthma
Safety and Efficacy Comparison Between CHF5993 100/6 12.5µg pMDI to Seretide Evohaler 125/25µg pMDI in Adolescent Subjects With Asthma
The CLI-05993AA5-06 study is an interventional study designed to investigate the safety and efficacy of a new experimental drug called CHF5993 pMDI compared to the currently approved Seretide 125 Evohaler pMDI in adolescent…
- Trial name
- TRIADES (NCT07858123)
- Testing
- CHF5993 100/6/12.5 μg pMDI HFA-152a, Seretide Evohaler
- Where
- 25 sites in Germany, Italy and 1 more
- Volunteers
- 700 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Epidermolysis Bullosa, Dystrophic, Epidermolysis Bullosa, Junctional
A Study to Assess the Incidence of Skin Cancers in Patients With Epidermolysis Bullosa Receiving Filsuvez
In patients with epidermolysis bullosa (EB), collagen does not form properly, so their skin is very fragile and blisters easily. Such patients are also at greatly increased risk of developing skin cancers.
- Trial name
- FOSteR (NCT06423573)
- Testing
- Filsuvez
- Where
- 12 sites in United States, France and 4 more
- Volunteers
- 170 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Fabry Disease
A Study to Learn About the Safety and Effects of the Study Drug PRX-102 in Children and Adolescents With Fabry Disease
A Study to Learn About the Safety and Effects of the Study Drug PRX-102 in Children and Adolescents with Fabry Disease.
- Trial name
- FLY (NCT06328608)
- Testing
- PRX-102 1 mg/kg every two weeks
- Where
- 12 sites in United States, Austria and 4 more
- Volunteers
- 22 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Familial Partial Lipodystrophy
Open-label Extension Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy
This Phase 3 study is an Open Label Extension of the APG-20 Study To Evaluate the Long-term Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects with Partial Lipodystrophy
- Trial name
- NCT06679270
- Testing
- Metreleptin
- Where
- 7 sites in United States
- Volunteers
- 24 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Generalised Lipodystrophy, Partial Lipodystrophy
MEASuRE: Metreleptin Effectiveness And Safety Registry
The study is a post-authorization, prospective, voluntary registry of patients treated with commercial metreleptin including, but not limited to, patients in the US and EEA.
- Trial name
- MEASuRE (NCT02325674)
- Testing
- Metreleptin
- Where
- 28 sites in United States, France and 3 more
- Volunteers
- 100 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Bronchiectasis
A Study to Evaluate the Efficacy and Safety of CHF10196 Tablets (Florensocatib) Compared With Placebo in Male and Female Participants 12 to 85 Years of Age With Bronchiectasis
This study aims to find out whether the tablet CHF10196 is safe and effective for people with non-cystic fibrosis bronchiectasis, a long-term lung disease that causes widened airways, mucus buildup, infections, and flare ups of…
- Trial name
- FABLE (NCT07577804)
- Testing
- CHF10196 tablets (florensocatib)
- Volunteers
- 904 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Partial Lipodystrophy
Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL
This is a Phase III, double-blind, placebo-controlled, safety and efficacy study of daily SC metreleptin in subjects with Partial Lipodystrophy.
- Trial name
- METRE-PL (NCT05164341)
- Testing
- metreleptin
- Where
- 31 sites in United States, Belgium and 7 more
- Volunteers
- 69 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Fabry Disease, Pregnancy
Maternal and Postnatal Outcomes Study (MOS): A Global Observational Registry Assessing the Safety of Elfabrio® in Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding
The goal of this observational registry is to evaluate the safety and outcomes of pregnancy and lactation in women with Fabry disease who are exposed to pegunigalsidase alfa within 30 days prior to conception and/or during…
- Conditions
- Fabry Disease, Pregnancy, Pregnancy Complications
- Trial name
- MOS (NCT06941025)
- Testing
- Not applicable- observational study
- Where
- 5 sites in United States, Germany and 3 more
- Volunteers
- 10 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Fabry Disease
Study to Evaluate the Safety, PK, PD, and Efficacy of PRX-102 in Japanese Patients With Fabry Disease
The aim of this study is to evaluate the safety and efficacy of pegunigalsidase alfa in Japanese patients (adults and adolescents) affected by Fabry disease.
- Trial name
- RISE (NCT05710692)
- Testing
- PRX-102 1 mg/kg every 2 weeks, PRX-102 2 mg/kg every 4 weeks
- Where
- 10 sites in Japan
- Volunteers
- 16 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Epidermolysis Bullosa, Junctional Epidermolysis Bullosa
A Study to Learn About the Safety and Efficacy of the Drug Oleogel-S10 in Japanese Patients With Epidermolysis Bullosa
The goal of this clinical trial is to learn if Oleogel-S10 gel works to treat skin wounds from two types of inherited epidermolysis bullosa (EB): junctional EB (JEB) or dystrophic EB (DEB) in the Japanese population.
- Conditions
- Epidermolysis Bullosa, Junctional Epidermolysis Bullosa, Epidermolysis Bullosa, Dystrophic, Epidermolysis Bullosa, Junctional
- Trial name
- REVIVE (NCT06917690)
- Testing
- Oleogel-S10
- Where
- 6 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
A Comparison Study Between Adolescents With Asthma and Adults With Asthma on How They Absorb, Metabolise and Eliminate CHF 6001
The purpose of this study is to evaluate the amount of the study drug, CHF6001, in the blood of adolescent patients with asthma in comparison to adult patients with asthma after a single oral dose of the study drug, CHF 6001.
- Trial name
- NCT06900816
- Testing
- CHF 6001
- Where
- Bulgaria
- Volunteers
- 50 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Alpha-Mannosidosis
Analysis of Velmanase Alfa (Lamzede®)'s Effects in the Body of Children With Alpha-Mannosidosis Under the Age 3
The goal of this observational study is to learn the effects of the drug velmanase alfa (Lamzede®) in the bodies of children under the age of 3 with Alpha-Mannosidosis.
- Trial name
- LAMPO(0-3) (NCT06184503)
- Testing
- Velmanase Alfa
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Pediatric Perioperative Blood Pressure Management
Assessment of Efficacy, Safety and Dosing of Clevidipine in Pediatric Participants Undergoing Surgery (PIONEER)
Evaluate the efficacy, safety, and dosing of clevidipine as an intravenous (IV) infusion for blood pressure (BP) management in paediatric participants in the perioperative setting.
- Trial name
- PIONEER (NCT01938547)
- Testing
- clevidipine
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Adenosine Deaminase Severe Combined Immunodeficiency
Registry Study of Revcovi Treatment in Patients With ADA-SCID
This registry study is being conducted in patients with adenosine deaminase severe combined immune deficiency (ADA-SCID) who require enzyme replacement therapy (ERT) treatment with Revcovi.
- Trial name
- NCT03878069
- Testing
- elapegademase-lvlr
- Where
- 14 sites in United States
- Volunteers
- 32 people
- 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.
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.