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Clinical trials for Developmental Process

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   43881   clinical trials with a EudraCT protocol, of which   7295   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    12 result(s) found for: Developmental Process. Displaying page 1 of 1.
    EudraCT Number: 2006-006126-25 Sponsor Protocol Number: 06 038 Start Date*: 2007-06-08
    Sponsor Name:CNRS: VAN DER REST Michel
    Full Title: Emotional and Social deficits in Asperger syndrome
    Medical condition: We investigate the Asperger Syndrome, it's a pervasive developmental condition related to autism. It manifests in highly individual ways and can have both positive and negative effects on a person....
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-002979-34 Sponsor Protocol Number: LTFU-ABO-102 Start Date*: 2020-05-18
    Sponsor Name:Abeona Therapeutics Inc
    Full Title: A Long-term Follow-up Study of Patients with MPS IIIA from Gene Therapy Clinical Trials Involving the Administration of ABO-102 (scAAV9.U1a.hSGSH)
    Medical condition: MPS IIIA is a devastating lysosomal storage disease, caused by a Nsulfoglucosamine sulfohydrolase gene defect. Infants with MPS IIIA appear normal at birth, but the disease is relentlessly progress...
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10056890 Mucopolysaccharidosis III PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-002936-97 Sponsor Protocol Number: LTFU-ABO-101 Start Date*: Information not available in EudraCT
    Sponsor Name:Abeona Therapeutics Europe SL.
    Full Title: A Long-term Follow-up Study of Patients with MPS IIIB from Gene Therapy Clinical Trials Involving the Administration of ABO-101 (rAAV9.CMV.hNAGLU)
    Medical condition: MPS IIIB is a devastating lysosomal storage disease, caused by a N-α-acetylglucosaminidase (NAGLU) gene defect. Infants with MPS IIIB appear normal at birth, but the disease is relentlessly progres...
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10056890 Mucopolysaccharidosis III PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-006781-21 Sponsor Protocol Number: COAV101A12308 Start Date*: 2022-10-31
    Sponsor Name:Novartis Pharma AG
    Full Title: Long-term follow-up of patients with spinal muscular atrophy Treated with OAV101 IT or OAV101 IV in Clinical Trials
    Medical condition: Spinal Muscular Atrophy
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10041582 Spinal muscular atrophy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Ongoing) IT (Ongoing) DE (Completed) DK (Ongoing) ES (Ongoing) GR (Ongoing) NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-003960-20 Sponsor Protocol Number: SHP-610-201 Start Date*: 2015-02-18
    Sponsor Name:Shire human Genetic Therapies, Inc.
    Full Title: A Open-Label Extension of Study HGT-SAN-093 Evaluating the Safety and Efficacy Study of HGT-1410 (Recombinant Human Heparan N Sulfatase) Administration via an Intrathecal Drug Delivery Device in...
    Medical condition: Sanfilippo Syndrome Type A or Mucopolysaccharidosis (MPS IIIA)
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10056918 Sanfilippo's syndrome LLT
    17.1 10010331 - Congenital, familial and genetic disorders 10056890 Mucopolysaccharidosis III PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) DE (Prematurely Ended) NL (Completed) GB (Prematurely Ended) FR (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-002611-26 Sponsor Protocol Number: AVXS-101-LT-002 Start Date*: 2020-03-30
    Sponsor Name:AveXis, Inc.
    Full Title: A Long-term Follow-up Study of Patients in the Clinical Trials for Spinal Muscular Atrophy Receiving AVXS-101
    Medical condition: Spinal Muscular Atrophy
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Ongoing) ES (Prematurely Ended) FR (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-005444-35 Sponsor Protocol Number: C4591015 Start Date*: 2021-04-15
    Sponsor Name:BioNTech SE
    Full Title: A PHASE 2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SARS-COV-2 RNA VACCINE CANDIDATE (BNT162b2) AGAINST COVID-19 IN HEAL...
    Medical condition: Protection against COVID-19
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10051905 Coronavirus infection PT
    Population Age: In utero, Under 18, Adults Gender: Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2013-002885-38 Sponsor Protocol Number: HGT-HIT-094 Start Date*: 2013-10-22
    Sponsor Name:Shire HGT Inc
    Full Title: A Controlled,Randomized,Two-arm,Open-label,Assessor-blinded,Multicenter Study of Intrathecal Idursulfase-IT Administered in Conjunction with Elaprase® in Pediatric Patients with Hunter Syndrome and...
    Medical condition: Long-term treatment of Hunter syndrome and cognitive impairment
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10056889 Mucopolysaccharidosis II PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male
    Trial protocol: GB (Completed) ES (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-004143-13 Sponsor Protocol Number: SHP-609-302 Start Date*: 2015-03-19
    Sponsor Name:Shire Human Genetic Therapies, Inc.
    Full Title: An Open Label Extension of Study HGT-HIT-094 Evaluating Long Term Safety and Clinical Outcomes of Intrathecal Idursulfase Administered in Conjunction with Elaprase® in Patients with Hunter Syndrome...
    Medical condition: Hunter syndrome and cognitive impairment
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10056889 Mucopolysaccharidosis II PT
    20.0 10010331 - Congenital, familial and genetic disorders 10056917 Hunter's syndrome LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Ongoing) FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-004478-80 Sponsor Protocol Number: Issue1 Start Date*: 2014-01-08
    Sponsor Name:University Hospital Bristol NHS Foundation Trust
    Full Title: XENON AND COOLING THERAPY IN BABIES AT HIGH RISK OF BRAIN INJURY FOLLOWING POOR CONDITION AT BIRTH: A RANDOMISED OUTCOME STUDY (COOLXENON3 STUDY)
    Medical condition: Neonatal hypoxia-ischaemia (HI). There is no exact MedDRA term for this. The closest MedDRA terms matching this are neonatal asphyxia and neonatal hypoxia.
    Disease: Version SOC Term Classification Code Term Level
    16.1 10038738 - Respiratory, thoracic and mediastinal disorders 10028923 Neonatal asphyxia PT
    16.1 100000004868 10028946 Neonatal hypoxia and asphyxia HLT
    16.1 10038738 - Respiratory, thoracic and mediastinal disorders 10050081 Neonatal hypoxia PT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2011-005397-34 Sponsor Protocol Number: Issue1 Start Date*: 2012-02-24
    Sponsor Name:University Hospital Bristol NHS Foundation Trust
    Full Title: Xenon and cooling therapy in babies at high risk of brain injury following poor condition at birth: Randomised pilot study. (CoolXenon2 study)
    Medical condition: Neonatal hypoxia-ischaemia (HI). There is no exact MedDRA term for this. The closest MedDRA terms matching this are neonatal asphyxia and neonatal hypoxia.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10050081 Neonatal hypoxia PT
    14.1 10036585 - Pregnancy, puerperium and perinatal conditions 10028946 Neonatal hypoxia and asphyxia HLT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10028923 Neonatal asphyxia PT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-000618-20 Sponsor Protocol Number: 40084-22084 Start Date*: 2012-11-05
    Sponsor Name:European Organization for the Research and Treatment of Cancer (EORTC)
    Full Title: A PHASE II-R and A PHASE III TRIAL EVALUATING BOTH *ERLOTINIB (PH II-R) AND CHEMORADIATION (PH III) AS ADJUVANT TREATMENT FOR PATIENTS WITH RESECTED HEAD OF PANCREAS ADENOCARCINOMA
    Medical condition: Patients with resected head of pancreas adenocarcinoma
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052747 Adenocarcinoma pancreas PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Ongoing) ES (Ongoing)
    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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