interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development
EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
Clinical Trials Information System (CTIS).
The EU Clinical Trials Register currently displays
44412
clinical trials with a EudraCT protocol, of which
7421
are clinical trials conducted with subjects less than 18 years old.
The register also displays information on
18700
older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see
Frequently Asked Questions ).
Full Title: A MULTINATIONAL, MULTICENTER, MASKED, RANDOMIZED, CONTROLLED
STUDY TO ASSESS THE SAFETY AND EFFICACY OF LUCINACTANT FOR
INHALATION IN PRETERM NEONATES 26 TO 32 WEEKS GESTATIONAL AGE
WITH RESPIRATOR...
Medical condition: Respiratory Distress Syndrome (RDS)
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10038738 - Respiratory, thoracic and mediastinal disorders
10021735
Infant respiratory distress syndrome
LLT
20.0
10038738 - Respiratory, thoracic and mediastinal disorders
10038690
Respiratory distress syndrome (neonatal)
LLT
20.0
10038738 - Respiratory, thoracic and mediastinal disorders
Sponsor Name:Windtree Therapeutics, Inc. (formerly Discovery Laboratories, Inc.)
Full Title: A Multicenter, Randomized, Open-Label, Controlled Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Preterm Neonates 26 to 28 Weeks PMA.
Medical condition: Respiratory Distress Syndrome (RDS)
Disease:
Version
SOC Term
Classification Code
Term
Level
19.1
10038738 - Respiratory, thoracic and mediastinal disorders
10021735
Infant respiratory distress syndrome
LLT
19.1
10038738 - Respiratory, thoracic and mediastinal disorders
10038690
Respiratory distress syndrome (neonatal)
LLT
19.1
10038738 - Respiratory, thoracic and mediastinal disorders
Full Title: A Multinational, Multicenter, Masked, Randomized, Parallel Group, Controlled Study to Assess the Safety and Efficacy of Lucinactant for Inhalation versus nCPAP alone in Preterm Neonates 26 to 32 We...
Medical condition: Respiratory Distress Syndrome (RDS)
Disease:
Version
SOC Term
Classification Code
Term
Level
21.1
10038738 - Respiratory, thoracic and mediastinal disorders
10021735
Infant respiratory distress syndrome
LLT
21.1
10038738 - Respiratory, thoracic and mediastinal disorders
10038690
Respiratory distress syndrome (neonatal)
LLT
21.1
10038738 - Respiratory, thoracic and mediastinal disorders
Full Title: A FIRST IN HUMAN CLINICAL STUDY ON THE SAFETY AND TOLERABILITY OF TWO ESCALATING SINGLE DOSES OF CHF 5633 (SYNTHETIC SURFACTANT) IN PRETERM NEONATES WITH RESPIRATORY DISTRESS SYNDROME
Medical condition: preterm neonates with Respiratory Distress Syndrome (RDS)
Disease:
Version
SOC Term
Classification Code
Term
Level
16.0
10038738 - Respiratory, thoracic and mediastinal disorders
10038690
Respiratory distress syndrome (neonatal)
LLT
16.0
10038738 - Respiratory, thoracic and mediastinal disorders
Full Title: Surfactant application during spontaneous breathing with CPAP or during mechanical ventilation in the therapy of IRDS in premature infants <27 weeks
Medical condition: Idiopathic Respiratory Distress Syndrome (IRDS) in preterm infants
Disease:
Version
SOC Term
Classification Code
Term
Level
14.0
10038738 - Respiratory, thoracic and mediastinal disorders
Full Title: A Phase 2, Open-Label Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Exploratory Clinical Activity of ALN-TTRSC in Patients with Transthyretin (TTR) Cardiac Amyloidosis
Medical condition: Transthyretin (TTR) Cardiac Amyloidosis
Disease:
Version
SOC Term
Classification Code
Term
Level
16.1
10010331 - Congenital, familial and genetic disorders
Full Title: A Phase 2, Open-label Extension Study to Evaluate the Long-Term Safety, Clinical Activity, and Pharmacokinetics of ALN-TTRSC in Patients with Transthyretin (TTR) Cardiac Amyloidosis Who Have Previo...
Medical condition: Transthyretin (TTR) Cardiac Amyloidosis
Disease:
Version
SOC Term
Classification Code
Term
Level
19.0
10010331 - Congenital, familial and genetic disorders
Full Title: A Phase 3b, Open-Label Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Cystic Fibrosis and Advanced Lung Disease, Homozygous for the F508del-CFTR ...
Medical condition: Cystic Fibrosis
Disease:
Version
SOC Term
Classification Code
Term
Level
19.1
10010331 - Congenital, familial and genetic disorders
Sponsor Name:Bristol-Myers Squibb International Corporation
Full Title: A Prospective, Randomized, Open Label, Multi-center Study of the Safety and Pharmacokinetics of Apixaban versus Vitamin K Antagonist or LMWH in Pediatric Subjects with Congenital or Acquired Heart ...
Medical condition: Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10010331 - Congenital, familial and genetic disorders
10019273
Heart disease congenital
PT
20.0
10007541 - Cardiac disorders
10007636
Cardiomyopathy
PT
20.0
10007541 - Cardiac disorders
10019276
Heart disease, unspecified
LLT
20.0
10038738 - Respiratory, thoracic and mediastinal disorders
10037400
Pulmonary hypertension
PT
20.0
10047065 - Vascular disorders
10023320
Kawasaki's disease
PT
Population Age: Infants and toddlers, Children, Adolescents, Under 18
Gender: Male, Female
Trial protocol:DE(Completed)GB(GB - no longer in EU/EEA)IT(Completed)FI(Completed)AT(Completed)ES(Prematurely Ended)
Full Title: A Phase 4, Open-label Treatment, Randomized, Multicenter, 2-arm, Parallelgroup, Pilot Study of Adherence to Lumacaftor/Ivacaftor in CF Subjects Homozygous for the F508del-CFTR Mutation
Medical condition: Cystic fibrosis subjects Homozygous for the F508del-CFTR Mutation
Disease:
Version
SOC Term
Classification Code
Term
Level
19.1
10010331 - Congenital, familial and genetic disorders
Full Title: Less opioids after major abdominal surgery in young infants using wound catheter infusion with local anesthetics: a randomized controlled trial.
Medical condition: Children < 1 year of age undergoing major open abdominal surgery.
Disease:
Version
SOC Term
Classification Code
Term
Level
20.1
10010331 - Congenital, familial and genetic disorders
10021298
Ileal atresia
PT
20.1
10010331 - Congenital, familial and genetic disorders
10010526
Congenital large intestinal atresia
PT
20.1
10010331 - Congenital, familial and genetic disorders
10002120
Anal atresia
PT
20.1
10010331 - Congenital, familial and genetic disorders
10010626
Congenital small intestinal atresia
PT
20.1
10010331 - Congenital, familial and genetic disorders
10062022
Intestinal atresia
PT
20.1
10010331 - Congenital, familial and genetic disorders
10013812
Duodenal atresia
PT
20.1
10010331 - Congenital, familial and genetic disorders
10028210
Multiple gastrointestinal atresias
PT
Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18
Sponsor Name:Alder Hey Children's NHS Foundation Trust
Full Title: The cystic fibrosis (CF) anti-staphylococcal antibiotic prophylaxis trial (CF START); a randomised registry trial to assess the safety and efficacy of flucloxacillin as a longterm prophylaxis agent...
Medical condition: Cystic fibrosis
Disease:
Version
SOC Term
Classification Code
Term
Level
19.0
10010331 - Congenital, familial and genetic disorders
10011762
Cystic fibrosis
PT
Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18
Full Title: A Prospective Phase III Multi-center, Placebo Controlled, Double Blind Study to Evaluate the Efficacy and Safety of “Kamada-AAT for Inhalation” 80 mg per day in Adult Patients with Congenital Alpha...
Medical condition: Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate and Severe Airflow Limitation (40% ≤ FEV1 ≤ 80% of predicted; FEV1/SVC ≤ 70%), and with no history of two or more moderat...
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10010331 - Congenital, familial and genetic disorders
10010331
Congenital, familial and genetic disorders
SOC
Population Age: Adults
Gender: Male, Female
Trial protocol:NL(Trial now transitioned)GB(GB - no longer in EU/EEA)IE(Trial now transitioned)SE(Trial now transitioned)FI(Trial now transitioned)BE(Trial now transitioned)
Trial results:(No results available)
EudraCT Number: 2011-003473-29
Sponsor Protocol Number: Uni-Koeln-1488
Start Date*: 2012-11-19
Sponsor Name:University of Cologne
Full Title: Trial on treatment with inhaled furosemide of preterm and term neonates with transient tachypnoea
Medical condition: In this study we will prospectively analyze the benefit of inhaled furosemide for preterm and term neonates with transient tachypnoea. Patients received nebulised Furosemide iv solution 1 mg/kg or ...
Disease:
Version
SOC Term
Classification Code
Term
Level
14.1
10038738 - Respiratory, thoracic and mediastinal disorders
10044403
Transient tachypnoea of the newborn
PT
Population Age: Preterm newborn infants, Newborns, Under 18
Full Title: An Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of Migalastat Hydrochloride Monotherapy in subjects with Fabry Disease
Medical condition: Fabry disease is a rare X-linked lysosomal storage disorder caused by mutations in the gene (GLA) that encodes the lysosomal enzyme a-galactosidase A.
Disease:
Version
SOC Term
Classification Code
Term
Level
19.1
10010331 - Congenital, familial and genetic disorders
Full Title: A Phase 3, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozy...
Medical condition: Cystic Fibrosis
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10010331 - Congenital, familial and genetic disorders
Full Title: Doxapram versus placebo in preterm newborns:
an international double blinded multicenter randomized controlled trial.
Medical condition: Preterm infants are at high risk of respiratory failure due to immaturity of the respiratory system. Respiratory failure is caused by a comprised lung function and impaired control of breathing. Co...
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10038738 - Respiratory, thoracic and mediastinal disorders
10077323
Infantile mixed apnea
LLT
Population Age: Preterm newborn infants, Under 18
Gender: Male, Female
Trial protocol:NL(Trial now transitioned)BE(Trial now transitioned)
Trial results:(No results available)
EudraCT Number: 2016-000067-16
Sponsor Protocol Number: AMO-02-MD-2-001
Start Date*: 2016-04-20
Sponsor Name:AMO Pharma Ltd.
Full Title: A Single-Blind, Phase 2 Study To Evaluate The Safety And Efficacy Of Tideglusib 400 mg Or 1000 mg For The Treatment Of Adolescent And Adult Congenital And Juvenile-Onset Myotonic Dystrophy
Medical condition: Treatment of adolescent and adult congenital and juvenile onset myotonic dystrophy
Disease:
Version
SOC Term
Classification Code
Term
Level
19.1
10010331 - Congenital, familial and genetic disorders
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