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Clinical trials for Neonatal hepatitis

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • 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   44352   clinical trials with a EudraCT protocol, of which   7379   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 ).  
     
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    17 result(s) found for: Neonatal hepatitis. Displaying page 1 of 1.
    EudraCT Number: 2012-005718-20 Sponsor Protocol Number: 111315 Start Date*: 2015-04-01
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase 2, open, randomized, controlled, multi-center study to evaluate the safety and immunogenicity of 7 infant immunization schedules of the RTS,S/AS01E candidate vaccine against P. falciparum.
    Medical condition: Healthy volunteers (Primary immunization against Plasmodium falciparum malaria)
    Disease:
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-004394-10 Sponsor Protocol Number: ACT16248 Start Date*: 2020-06-30
    Sponsor Name:Genzyme Corporation
    Full Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacodynamics, and Pharmacokinetics of Lademirsen (SAR339375) for Subcutaneous Injection Administe...
    Medical condition: Congenital, hereditary and neonatal diseases
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10001843 Alport's syndrome PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2008-005508-14 Sponsor Protocol Number: 08/0171 Start Date*: 2010-02-09
    Sponsor Name:University College london
    Full Title: A phase 3 randomized, placebo-controlled blinded investigation of six weeks vs. six months of oral valgancoclovir therapy in infants with symtomatic congenital cytomegalovirus infection. DMID # 06-...
    Medical condition: Symptomatic Congenital Cytomegalovirus.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10010430 Congenital cytomegalovirus infection PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-005490-20 Sponsor Protocol Number: 2002C011G Start Date*: 2016-06-29
    Sponsor Name:ProMetic BioTherapeutics Inc.
    Full Title: A Phase 2/3, Open-Label, Repeat-Dose Study of the Pharmacokinetics, Efficacy, and Safety of ProMetic Plasminogen Intravenous Infusion in Subjects with Hypoplasminogenemia
    Medical condition: Hypoplasminogenemia
    Disease: Version SOC Term Classification Code Term Level
    18.1 10022891 - Investigations 10035493 Plasminogen decreased PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed)
    Trial results: View results
    EudraCT Number: 2017-002783-40 Sponsor Protocol Number: 000304 Start Date*: 2019-07-04
    Sponsor Name:Ferring Pharmaceuticals A/S
    Full Title: A randomised, controlled, open label, parallel group, multicentre trial comparing the efficacy and safety of individualised FE 999049 (follitropin delta) dosing, using a long GnRH agonist protocol ...
    Medical condition: Infertility in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004872 10016398 Female infertility LLT
    21.0 100000004872 10016403 Female infertility of tubal origin LLT
    21.1 100000004872 10025511 Male infertility, unspecified LLT
    21.0 100000004872 10014787 Endometriosis of uterus LLT
    21.0 100000004872 10014784 Endometriosis of ovary LLT
    Population Age: Adults Gender: Female
    Trial protocol: AT (Completed) DK (Completed) NO (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-003762-33 Sponsor Protocol Number: 106481 Start Date*: 2006-12-06
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIIb, double blind, randomised, placebo–controlled, multi–country, multicentre study to assess the safety, reactogenicity and immunogenicity of two doses of GlaxoSmithKline (GSK) Biological...
    Medical condition: Primary immunisation of pre–term infants against human rotavirus gastroenteritis (GE)
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) PT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2014-005401-20 Sponsor Protocol Number: CSLCT-BIO-03-97 Start Date*: 2015-01-30
    Sponsor Name:CSL Limited
    Full Title: An Open-label, Multi-centre Study to Assess the Efficacy and Safety of Biostate® in Patients With von Willebrand's Disease (VWD)
    Medical condition: Von Willebrand's disease (VWD)
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10047715 Von Willebrand's disease PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-000102-25 Sponsor Protocol Number: ALXN1840-WD-Cu-Excretion Start Date*: 2021-04-09
    Sponsor Name:Aarhus University Hospital
    Full Title: Efficacy of ALXN1840 on human biliary copper excretion quantified with 64CuCl2 PET/MR-scan
    Medical condition: Wilson's Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10047988 Wilson's disease LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2014-003835-20 Sponsor Protocol Number: ALN-TTRSC-004 Start Date*: 2014-11-26
    Sponsor Name:Alnylam Pharmaceuticals, Inc.
    Full Title: A Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyl...
    Medical condition: Transthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC)
    Disease: Version SOC Term Classification Code Term Level
    18.1 10010331 - Congenital, familial and genetic disorders 10016202 Familial amyloidosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) SE (Completed) DE (Completed) ES (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-001054-42 Sponsor Protocol Number: CSL830_3002 Start Date*: 2015-03-04
    Sponsor Name:CSL Behring GmbH
    Full Title: An open-label, randomized study to evaluate the long-term clinical safety and efficacy of subcutaneous administration of human plasma-derived C1-esterase inhibitor in the prophylactic treatment of ...
    Medical condition: Hereditary Angioedema Types I and II
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) HU (Completed) CZ (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-000254-64 Sponsor Protocol Number: 114056 Start Date*: 2012-04-12
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, open, controlled study to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10- valent pneumococcal conjugate vaccine administered to children with sickle cell...
    Medical condition: Active immunization against disease caused by Streptococcus pneumoniae in children from 8 weeks up to 2 years of age.
    Disease: Version SOC Term Classification Code Term Level
    17.1 10021881 - Infections and infestations 10061190 Haemophilus infection PT
    17.1 10021881 - Infections and infestations 10061353 Pneumococcal infection PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-005464-21 Sponsor Protocol Number: DiagnosingWD-PET/MR-pilot Start Date*: 2022-07-07
    Sponsor Name:Aarhus University Hospital
    Full Title: Diagnosing Wilson’s Disease with 64-Cu PET/MR – A Pilot Study
    Medical condition: Wilson's disease
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004848 10036223 Positron emission tomography LLT
    20.0 100000004850 10047988 Wilson's disease LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2013-002987-17 Sponsor Protocol Number: ALN-TTR02-004 Start Date*: 2013-11-25
    Sponsor Name:Alnylam Pharmaceuticals, Inc
    Full Title: APOLLO: A Phase 3 Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Patisiran (ALN-TTR02) in Transthyretin (TTR)-Mediated Polyneu...
    Medical condition: Transthyretin mediated amyloidosis (ATTR)
    Disease: Version SOC Term Classification Code Term Level
    19.0 10007541 - Cardiac disorders 10007509 Cardiac amyloidosis PT
    19.0 10010331 - Congenital, familial and genetic disorders 10019889 Hereditary neuropathic amyloidosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) ES (Completed) PT (Completed) IT (Completed) DE (Completed) NL (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-000467-24 Sponsor Protocol Number: ALN-TTR02-002 Start Date*: 2012-05-08
    Sponsor Name:Alnylam Pharmaceuticals, Inc.
    Full Title: A Phase 2, Open-Label, Multi-Dose, Dose Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Infusions of ALN-TTR02 in Patients with TTR Amyl...
    Medical condition: Transthyretin mediated amyloidosis (ATTR)
    Disease: Version SOC Term Classification Code Term Level
    15.1 10007541 - Cardiac disorders 10007509 Cardiac amyloidosis PT
    15.1 10010331 - Congenital, familial and genetic disorders 10019889 Hereditary neuropathic amyloidosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) PT (Completed) DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2012-003450-92 Sponsor Protocol Number: IG1005 Start Date*: 2013-11-23
    Sponsor Name:Instituto Grifols S.A.
    Full Title: EVALUATION OF THE PHARMACOKINETIC PROFILE, CLINICAL EFFICACY AND SAFETY OF THE VON WILLEBRAND FACTOR CONTAINED IN FANHDI® (DOUBLE-INACTIVATED HUMAN ANTI-HEMOPHILIC FACTOR) IN PEDIATRIC PATIENTS WIT...
    Medical condition: Severe von Willebrand disease including types I, II, and III with VWF:RCof <15-20%
    Disease: Version SOC Term Classification Code Term Level
    14.1 10022891 - Investigations 10068986 Von Willebrand's factor activity decreased PT
    14.1 10010331 - Congenital, familial and genetic disorders 10047715 Von Willebrand's disease PT
    14.1 10010331 - Congenital, familial and genetic disorders 10055168 Von Willebrand's factor deficiency LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-005266-34 Sponsor Protocol Number: UX701-CL301 Start Date*: 2022-02-11
    Sponsor Name:Ultragenyx Pharmaceutical Inc.
    Full Title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Seamless, Adaptive, Safety, Dose-finding, and Phase 3 Clinical Study of UX701 AAV-mediated Gene Transfer for the Treatment of Wilson Dis...
    Medical condition: Wilson disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10047988 Wilson's disease LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Trial now transitioned) PT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-001991-32 Sponsor Protocol Number: BN42489 Start Date*: 2023-01-13
    Sponsor Name:F.Hoffmann-La Roche Ltd
    Full Title: A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, BIOMARKERS, AND EFFICACY OF TOMINERSEN IN INDIVIDUALS WITH PRODROMAL AND EARLY MANIFEST HUNTINGT...
    Medical condition: Huntington's disease (HD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10070668 Huntington's disease PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Trial now transitioned) AT (Trial now transitioned) PT (Trial now transitioned) PL (Trial now transitioned) ES (Ongoing) DE (Ongoing) FR (Trial now transitioned)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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