Clinical trials: Newborn Infant
Retinopathy of Prematurity (ROP), Intraventricular Hemorrhage
Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
The purpose of this study is to evaluate long-term safety and efficacy outcomes following previously administered short-term exposure to SHP607, as compared to a standard neonatal care group.
- Conditions
- Retinopathy of Prematurity (ROP), Intraventricular Hemorrhage, Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity
- Trial name
- NCT04506619
- Testing
- No Intervention
- Where
- 8 sites in United States, Italy and 1 more
- Volunteers
- 26 people
- Sponsor
- Oak Hill Bio Ltd
Retinopathy of Prematurity
A 24-week Study Evaluating the Effectiveness and Safety of Lucentis® 0.2mg in Retinopathy of Prematurity Participants in China
This is a 24-week, multicenter, open-label, single-arm, observational, post approval commitment study, which is designed to collect effectiveness, safety and other clinical information of intravitreal ranibizumab 0.2 mg for the…
- Trial name
- NCT05576792
- Testing
- Ranibizumab
- Where
- China
- Volunteers
- 62 people
- Sponsor
- Novartis Pharmaceuticals
Gut Microbiota Modulation
STUDY OF THE EFFECTS OF L. CASEI DG® (ENTEROLACTIS BABY) IN HEALTHY PRETERM AND FULL-TERM INFANTS.
The goal of this clinical trial was to learn whether giving Enterolactis Baby®, a probiotic food supplement containing Lactobacillus casei DG® (under the new taxonomical denomination: Lacticaseibacillus paracasei DG, CNCM…
- Trial name
- NCT07882537
- Testing
- Enterolactis Baby® drops
- Where
- Italy
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Alfasigma S.p.A.
Cystic Fibrosis (CF)
Safety, Tolerability and Efficacy of MP-376 Given for 28 Days to Cystic Fibrosis (CF) Patients
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to…
- Trial name
- NCT00677365
- Testing
- MP-376
- Where
- 50 sites in United States, Germany and 1 more
- Volunteers
- 151 people
- Sponsor
- Amgen
Colic
Study to Evaluate Efficacy and Safety of Oral Doses of Hyoscine Butylbromide for the Treatment of Occasional Abdominal Pain, Cramping, and Discomfort
Study to determine whether hyoscine butylbromide can provide adequate symptomatic relief of a single episode - defined as lasting not longer than 1 day - and multiple episodes of abdominal pain or discomfort associated with…
- Trial name
- NCT02242292
- Testing
- Hyoscine butylbromide
- Volunteers
- 527 people
- Sponsor
- Boehringer Ingelheim
Nutritional and Metabolic Diseases
Efficacy and Safety of Stannsoporfin in Neonates
This is a multi-center, randomized, sham injection-controlled (placebo) masked trial of a single intramuscular injection of Stannsoporfin compared to "sham" (placebo) in healthy term and near-term newborns admitted to the…
- Trial name
- NCT02685137
- Testing
- stannsoporfin
- Where
- United States
- Volunteers
- 185 people
- Sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
PR-018: An Open-Label, Safety Extension of Study PR-011
A study to evaluate long term safety and effect on ability to thrive of EUR-1008 (APT-1008) 3,000 lipase units (Zenpep® [pancrelipase] delayed release capsules) in infants with exocrine pancreatic insufficiency (EPI) due to…
- Trial name
- NCT01131507
- Testing
- EUR-1008 (APT-1008)
- Where
- 6 sites in United States
- Volunteers
- 15 people
- Sponsor
- Forest Laboratories
Cystic Fibrosis
28 Day Repeat Dose in Cystic Fibrosis Patients
The purpose of this study is to determine whether the safety, tolerability and pharmacodynamics of SB656933 in patients that have cystic fibrosis
- Trial name
- NCT00903201
- Testing
- SB656933
- Where
- 33 sites in United States, Canada and 3 more
- Volunteers
- 146 people
- Sponsor
- GlaxoSmithKline
Cystic Fibrosis
Safety, Tolerability, and Pharmacokinetics of ARCT-032 in Healthy Adult Subjects and Adults With Cystic Fibrosis.
Determine the safety, tolerability and pharmacokinetics of single doses of ARCT-032 in healthy adult subjects (Phase 1) and of two doses in Adults with Cystic Fibrosis (Phase 1b).
- Trial name
- NCT05712538
- Testing
- ARCT-032
- Where
- New Zealand
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Arcturus Therapeutics, Inc.
Cystic Fibrosis
A Multi-Center Study of the CF Quantum® Sweat Test System
This is an observational comparative study to compare the standard-of-care methods for sweat testing used to support diagnosing cystic fibrosis (CF) against a new method of sweat testing called the CF Quantum Sweat Test System.
- Trial name
- NCT02404714
- Testing
- Iontophoresis sweat test
- Where
- 6 sites in United States
- Volunteers
- 55 people
- Sponsor
- Polychrome Medical, Inc.
Cystic Fibrosis
An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.
- Trial name
- (HOPE-1) (NCT03229252)
- Testing
- SPX-101
- Where
- 25 sites in Canada, France and 3 more
- Volunteers
- 91 people
- Sponsor
- Spyryx Biosciences, Inc.
Premature Birth of Newborn
Oral Formulation of Insulin for Preterm Infants
The study will evaluate the effect of oral formulation of insulin on preterm infants, born between 26-33 weeks of pregnancy, weighing over 750 grams, who meet the inclusion and exclusion criteria established in this protocol.
- Trial name
- NCT01093638
- Testing
- Oral Formulation of Insulin
- Where
- Israel
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Elgan Pharma Ltd.
Cystic Fibrosis
A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Cystic Fibrosis
The purpose of this study is to investigate if treatment with AZD9668 for 28 days is effective in treating Cystic Fibrosis (CF) and if so how it compares to placebo (a substance which does not have any action).
- Trial name
- INCA (NCT00757848)
- Testing
- AZD9668
- Where
- 14 sites in Denmark, Germany and 4 more
- Volunteers
- 56 people
- Sponsor
- AstraZeneca
Cystic Fibrosis
A Study of Inhaled KB407 for the Treatment of Cystic Fibrosis
The Sponsor is developing KB407, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector engineered to deliver functional full-length human Cystic Fibrosis Transmembrane Conductance Regulator…
- Trial name
- NCT05095246
- Testing
- KB407 (Nebulization)
- Where
- Australia
- Sponsor
- Krystal Biotech, Inc.
Neonatal Sepsis
Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age
This study evaluated the safety, pharmacokinetics and efficacy of ceftobiprole in term and pre-term newborn babies and infants up to 3 months of age with late-onset sepsis (LOS).
- Trial name
- NCT05856227
- Testing
- Ceftobiprole medocaril
- Where
- 14 sites in United States, Bulgaria and 6 more
- Volunteers
- 9 people
- Sponsor
- Basilea Pharmaceutica
Mucopolysaccharidosis II
Mucopolysaccharidosis Type II Natural History
Mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, is caused by a deficiency of iduronate-2-sulfatase (IDS) leading to an accumulation of glycosaminoglycans (GAGs) in tissues of MPS II patients, resulting in…
- Trial name
- NCT03529786
- Where
- 3 sites in United States, Brazil and 1 more
- Volunteers
- 36 people
- Sponsor
- REGENXBIO Inc.
Chronic Rhinosinusitis, Cystic Fibrosis
Efficacy of Nasal Irrigation With Respimer® Netiflow® vs Saline Among Patients With Cystic Fibrosis and Chronic Rhinosinusitis
Prospective, randomized, cross-over, multicenter, trial comparing the efficacy and tolerability of nasal irrigation with Respimer® mineral salts solution versus saline solution both administered with Respimer® Netiflow® medical…
- Trial name
- Respire (NCT03145051)
- Testing
- Saline solution, Respimer Netiflow
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Laboratoire de la Mer
Dermatitis, Atopic
Curing Atopic Dermatits in Children With a Commerical Medical Device and Maintaining Healthy Skin by Using a New Cosmetic Product
1. Curing mild atopic dermatis in children with a commerical medical device (Bepanthen Itch Relief Cream). 2. Maintaining healthy skin by using a new cosmetic Bepanthen product or a commercially available cosmetic product
- Trial name
- NCT02615561
- Testing
- Bepanthen Itch Relief Cream: Phoenix 2 (Bepanthen Sensiderm, BAY207543), New cosmetic Bepanthen product: Pumpkin (BAY207543), Stelatopia (cosmetic comparator)
- Where
- 14 sites in Germany
- Volunteers
- 136 people
- Sponsor
- Bayer
Cystic Fibrosis (CF)
Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Trikafta
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SION-719 when given to people with CF who are already taking Trikafta.
- Trial name
- PreciSION CF (NCT07108153)
- Testing
- SION-719
- Where
- 13 sites in United States, Australia
- Volunteers
- 15 people
- Sponsor
- Sionna Therapeutics Inc.
Cystic Fibrosis
A Study Looking at the Safety, Tolerability and Efficacy of the Combination of the Study Drugs GLPG2451 and GLPG2222 With or Without GLPG2737 in Patients With Cystic Fibrosis.
This is a Phase Ib, multi-center, open-label, nonrandomized multiple cohorts study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of a combination treatment of GLPG2451 and GLPG2222…
- Trial name
- FALCON (NCT03540524)
- Testing
- GLPG2451 dose regimen A, GLPG2451 dose regimen B, GLPG2222
- Where
- 20 sites in Belgium, Bulgaria and 6 more
- Volunteers
- 10 people
- Sponsor
- Lakefront Biotherapeutics NV