- Trials with a EudraCT protocol (11)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
11 result(s) found for: Pulmonary Hypoplasia.
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EudraCT Number: 2016-003181-12 | Sponsor Protocol Number: HOTPOT1 | Start Date*: 2016-10-07 |
Sponsor Name:Royal College of Surgeons in Ireland | ||
Full Title: Can sonographic assessment of pulmonary vascular reactivity following maternal hyperoxygenation therapy predict neonatal outcome in fetuses at risk of pulmonary hypertension? | ||
Medical condition: Persistent pulmonary hypertension of the newborn (PPHN) is a relatively common condition occurring in 7/1000 births and can result in significant cardiovascular instability in the newborn. It occur... | ||
Disease: | ||
Population Age: Adults | Gender: Female | |
Trial protocol: IE (Completed) | ||
Trial results: View results |
EudraCT Number: 2020-004011-28 | Sponsor Protocol Number: A4250-012 | Start Date*: 2021-01-26 | |||||||||||
Sponsor Name:Albireo AB | |||||||||||||
Full Title: A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT) | |||||||||||||
Medical condition: Alagille Syndrome | |||||||||||||
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Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: FR (Completed) PL (Completed) NL (Completed) BE (Completed) DE (Completed) IT (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2021-000996-36 | Sponsor Protocol Number: A4250-015 | Start Date*: Information not available in EudraCT | |||||||||||
Sponsor Name:Albireo AB | |||||||||||||
Full Title: An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT-EXT) | |||||||||||||
Medical condition: Alagille Syndrome | |||||||||||||
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Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: FR (Ongoing) BE (Trial now transitioned) PL (Trial now transitioned) NL (Trial now transitioned) DE (Ongoing) IT (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2015-000906-20 | Sponsor Protocol Number: LUM001-601 | Start Date*: 2015-05-13 | ||||||||||||||||
Sponsor Name:Shire Human Genetic Therapies Inc | ||||||||||||||||||
Full Title: An Open-label, Multicenter Extension Study to Evaluate the Long-term Safety of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients with Alagille Syndrome (ALGS) ... | ||||||||||||||||||
Medical condition: Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC) | ||||||||||||||||||
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Population Age: Infants and toddlers, Children, Adolescents, Under 18 | Gender: Male, Female | |||||||||||||||||
Trial protocol: GB (Prematurely Ended) | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2012-005346-38 | Sponsor Protocol Number: LUM001-302 | Start Date*: 2013-06-11 | |||||||||||
Sponsor Name:Lumena Pharmaceuticals, Inc. | |||||||||||||
Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF LUM001, AN APICAL SODIUM-DEPENDENT BILE ACID TRANSPORTER INHIBITOR (ASBTi), IN THE TREATMENT OF CHOLESTAT... | |||||||||||||
Medical condition: Alagille syndrome (ALGS). This is an example of cholestatic liver disease in children. In patients with Alagille syndrome, impairment of the egress of bile acids from the liver leads to cholestasi... | |||||||||||||
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Population Age: Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: GB (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2013-005373-43 | Sponsor Protocol Number: LUM001-304 | Start Date*: 2014-08-05 | |||||||||||
Sponsor Name:Lumena Pharmaceuticals Inc | |||||||||||||
Full Title: Long-Term, Open-Label Study with a Double-Blind, Placebo Controlled, Randomized Drug Withdrawal Period of LUM001, an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients wit... | |||||||||||||
Medical condition: Alagille Syndrome | |||||||||||||
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Population Age: Infants and toddlers, Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: ES (Completed) PL (Completed) BE (Completed) GB (Completed) FR (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2020-004628-40 | Sponsor Protocol Number: MRX-801 | Start Date*: 2021-01-29 | ||||||||||||||||
Sponsor Name:Mirum Pharmaceuticals Inc | ||||||||||||||||||
Full Title: Open-Label, Phase 2 Study to Evaluate the Safety and Tolerability of Maralixibat in the Treatment of Infants with Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis ... | ||||||||||||||||||
Medical condition: Progressive Familial Intrahepatic Cholestasis and Alagille Syndrome | ||||||||||||||||||
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Population Age: Newborns, Infants and toddlers, Under 18 | Gender: Male, Female | |||||||||||||||||
Trial protocol: BE (Completed) FR (Ongoing) PL (Ongoing) | ||||||||||||||||||
Trial results: (No results available) |
EudraCT Number: 2018-001489-41 | Sponsor Protocol Number: P00003466 | Start Date*: 2018-07-02 | |||||||||||
Sponsor Name:Karolinska Universitetssjukhuset | |||||||||||||
Full Title: Radiation- and alkylator-free hematopoietic cell transplantation for bone marrow failure due to dyskeratosis congenita / telomere disease | |||||||||||||
Medical condition: Dyskeratosis congenita / telomere disease | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: SE (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2013-004565-14 | Sponsor Protocol Number: ECP-002e | Start Date*: 2014-02-13 | |||||||||||
Sponsor Name:Edimer Pharmaceuticals, Inc. | |||||||||||||
Full Title: Extension Study of XLHED-Affected Male Subjects treated with EDI200 in Protocol ECP-002 | |||||||||||||
Medical condition: X-linked hypohidrotic ectodermal dysplasia (XLHED) is caused by inherited defects in the ectodysplasin (EDA) gene that disrupt synthesis and/or function of the primary translational product EDA-A1.... | |||||||||||||
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Population Age: Infants and toddlers, Under 18 | Gender: Male | ||||||||||||
Trial protocol: DE (Completed) FR (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2019-002755-42 | Sponsor Protocol Number: MRX-800 | Start Date*: 2020-03-16 | |||||||||||||||||||||
Sponsor Name:Mirum Pharmaceuticals Inc. | |||||||||||||||||||||||
Full Title: MRX-800: A Long-Term Safety Study of Maralixibat, an Apical Sodium Dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Partic... | |||||||||||||||||||||||
Medical condition: Long-term safety study with Maralixibat, in treatment of subjects with cholestatic liver disease including, but not limited to, Alagille syndrome (ALGS) and Progressive Familial Intrahepatic Choles... | |||||||||||||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||||||||||||
Trial protocol: BE (Completed) GB (GB - no longer in EU/EEA) PL (Ongoing) FR (Completed) ES (Completed) | |||||||||||||||||||||||
Trial results: (No results available) |
EudraCT Number: 2012-003561-17 | Sponsor Protocol Number: ECP-002 | Start Date*: 2013-08-09 | |||||||||||
Sponsor Name:Edimer Pharmaceuticals, Inc. | |||||||||||||
Full Title: A Phase 2 open-label, dose-escalation study to evaluate the safety, pharmacokinetics, immunogeniticy and pharmacodynamics/efficacy of EDI200, an EDA-A1 replacement protein, administered to male inf... | |||||||||||||
Medical condition: X-linked hypohidrotic ectodermal dysplasia (XLHED) is caused by inherited defects in the ectodysplasin (EDA) gene that disrupt synthesis and/or function of the primary translational product EDA-A1.... | |||||||||||||
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Population Age: Newborns, Under 18 | Gender: Male | ||||||||||||
Trial protocol: DE (Completed) GB (Completed) IT (Completed) FR (Completed) | |||||||||||||
Trial results: View results |
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