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Generated: December 15, 2018

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CLINICAL TRIALS PROFILE FOR PORACTANT ALFA

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Clinical Trials for Poractant Alfa

Trial ID Title Status Sponsor Phase Summary
NCT00767039 Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants Terminated Dey LP Phase 4 Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome (RDS) in premature infants greatly improved survival rates. Newer surfactants approved by the FDA were more concentrated and had a more rapid onset of action. The overall efficacy of newer surfactants appeared similar until in 2004, Ramanathan and colleagues suggested that a double dose of Curosurf improved survival in infants 25-32 weeks gestational age, compared to infants treated with Survanta, the most commonly used surfactant preparation in the United States. While the data was suggestive, it was not clear that the improvement in survival was reproducible or that Curosurf was responsible for the improved survival rates. The purpose of this study was to investigate the role of Curosurf in improving lung function and survival rates and reducing the complications of prematurity in very premature infants < 30 weeks gestational age at birth.
NCT00767039 Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants Terminated Alan Fujii Phase 4 Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome (RDS) in premature infants greatly improved survival rates. Newer surfactants approved by the FDA were more concentrated and had a more rapid onset of action. The overall efficacy of newer surfactants appeared similar until in 2004, Ramanathan and colleagues suggested that a double dose of Curosurf improved survival in infants 25-32 weeks gestational age, compared to infants treated with Survanta, the most commonly used surfactant preparation in the United States. While the data was suggestive, it was not clear that the improvement in survival was reproducible or that Curosurf was responsible for the improved survival rates. The purpose of this study was to investigate the role of Curosurf in improving lung function and survival rates and reducing the complications of prematurity in very premature infants < 30 weeks gestational age at birth.
NCT02041546 Lung Lavage With Dilute Poractant Alfa for Meconium Aspiration Syndrome Completed Zekai Tahir Burak Women's Health Research and Education Hospital Phase 4 Meconium aspiration syndrome (MAS) is an important cause of severe respiratory failure in newborn infants. Treatment for MAS is mainly supportive but surfactant therapy might change the course of the disease. Aim of the study to evaluate whether lung lavage with dilute or bolus poractant alfa changes the duration of mechanical respiratory support or other outcomes in MAS.
NCT02452476 A Double Blind, Randomized, Controlled Study to Compare CHF 5633 (Synthetic Surfactant) and Poractant Alfa in RDS Recruiting Parexel Phase 2 A multicenter, double blind, randomized, single dose, active-controlled study to investigate the efficacy and safety of synthetic surfactant (CHF 5633) in comparison to porcine surfactant (Poractant alfa, Curosurf ®) in the treatment of preterm neonates with respiratory distress syndrome. Main objectives of this study are to investigate the short term efficacy profile of CHF 5633 vs. porcine surfactant (Poractant Alfa, Curosurf®) in terms of reduced oxygen requirement and ventilatory support and to evaluate the mid-term efficacy profile in terms of reduced incidence of bronchopulmonary dysplasia (BPD) and mortality/BPD rate at 36 weeks post menstrual age (PMA), mortality rate at 28 days and 36 weeks PMA, RDS-associated mortality through 14 days of age and other major co-morbidities of prematurity. Inclusion criteria are: Written parental informed consent, inborn preterm neonates of either sex with a gestational age of 24+0 weeks up to 29+6 weeks, clinical course consistent with RDS, requirement of endotracheal surfactant administration within 24 hours from birth, fraction of inspired oxygen (FiO2) ≥0.30 for babies 24+0 to 26+6 weeks and FiO2 ≥0.35 for babies 27+0 to 29+6 weeks to maintain SpO2 between 88-95%.
NCT02452476 A Double Blind, Randomized, Controlled Study to Compare CHF 5633 (Synthetic Surfactant) and Poractant Alfa in RDS Recruiting Chiesi Farmaceutici S.p.A. Phase 2 A multicenter, double blind, randomized, single dose, active-controlled study to investigate the efficacy and safety of synthetic surfactant (CHF 5633) in comparison to porcine surfactant (Poractant alfa, Curosurf ®) in the treatment of preterm neonates with respiratory distress syndrome. Main objectives of this study are to investigate the short term efficacy profile of CHF 5633 vs. porcine surfactant (Poractant Alfa, Curosurf®) in terms of reduced oxygen requirement and ventilatory support and to evaluate the mid-term efficacy profile in terms of reduced incidence of bronchopulmonary dysplasia (BPD) and mortality/BPD rate at 36 weeks post menstrual age (PMA), mortality rate at 28 days and 36 weeks PMA, RDS-associated mortality through 14 days of age and other major co-morbidities of prematurity. Inclusion criteria are: Written parental informed consent, inborn preterm neonates of either sex with a gestational age of 24+0 weeks up to 29+6 weeks, clinical course consistent with RDS, requirement of endotracheal surfactant administration within 24 hours from birth, fraction of inspired oxygen (FiO2) ≥0.30 for babies 24+0 to 26+6 weeks and FiO2 ≥0.35 for babies 27+0 to 29+6 weeks to maintain SpO2 between 88-95%.
NCT02482766 Efficacy of a New Technique -"IN-REC-SUR-E"- in Preterm Neonates With RDS Recruiting Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) N/A The primary hypothesis of this study is reduction in need of mechanical ventilation in the first 72 hours of life (excluding the transient tracheal intubation performed for surfactant administration and the mechanical ventilation for lung recruitment) in spontaneously breathing infants born at 24+0-27+6 weeks' gestation and failing nCPAP during the first 24 hours of life who received an HFOV recruitment maneuver (IN-REC-SUR-E) compared to no recruitment maneuver (IN-SUR-E) just prior to surfactant administration followed by prompt extubation.
NCT02482766 Efficacy of a New Technique -"IN-REC-SUR-E"- in Preterm Neonates With RDS Recruiting Azienda Ospedaliera San Gerardo di Monza N/A The primary hypothesis of this study is reduction in need of mechanical ventilation in the first 72 hours of life (excluding the transient tracheal intubation performed for surfactant administration and the mechanical ventilation for lung recruitment) in spontaneously breathing infants born at 24+0-27+6 weeks' gestation and failing nCPAP during the first 24 hours of life who received an HFOV recruitment maneuver (IN-REC-SUR-E) compared to no recruitment maneuver (IN-SUR-E) just prior to surfactant administration followed by prompt extubation.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Poractant Alfa

Condition Name

Condition Name for Poractant Alfa
Intervention Trials
Respiratory Distress Syndrome 4
Respiratory Distress Syndrome, Newborn 2
Neonatal Respiratory Distress Syndrome 1
Meconium Aspiration Syndrome 1
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Condition MeSH

Condition MeSH for Poractant Alfa
Intervention Trials
Syndrome 7
Respiratory Distress Syndrome, Newborn 7
Respiratory Distress Syndrome, Adult 7
Hyaline Membrane Disease 2
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Clinical Trial Locations for Poractant Alfa

Trials by Country

Trials by Country for Poractant Alfa
Location Trials
Italy 7
United States 4
Mexico 1
Turkey 1
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Trials by US State

Trials by US State for Poractant Alfa
Location Trials
Missouri 1
Oklahoma 1
Georgia 1
Massachusetts 1
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Clinical Trial Progress for Poractant Alfa

Clinical Trial Phase

Clinical Trial Phase for Poractant Alfa
Clinical Trial Phase Trials
Phase 4 3
Phase 3 1
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Poractant Alfa
Clinical Trial Phase Trials
Recruiting 3
Completed 2
Not yet recruiting 2
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Clinical Trial Sponsors for Poractant Alfa

Sponsor Name

Sponsor Name for Poractant Alfa
Sponsor Trials
Chiesi Farmaceutici S.p.A. 3
Centre for Neonatal Research and Education, Crawley, West Australia 1
Quintiles, Inc. 1
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Sponsor Type

Sponsor Type for Poractant Alfa
Sponsor Trials
Other 14
Industry 5
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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Chinese Patent Office
Accenture
AstraZeneca
Argus Health
Cerilliant
Medtronic
Daiichi Sankyo
Covington

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