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Clinical trials for Osteosclerosis

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   44335   clinical trials with a EudraCT protocol, of which   7366   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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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    18 result(s) found for: Osteosclerosis. Displaying page 1 of 1.
    EudraCT Number: 2013-002205-54 Sponsor Protocol Number: P100150 Start Date*: 2013-09-17
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title:
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10062909 Netherton's syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-003149-39 Sponsor Protocol Number: C4181008 Start Date*: 2021-12-14
    Sponsor Name:Pfizer Inc.
    Full Title: A PHASE 2 OPEN LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF RECIFERCEPT IN CHILDREN WITH ACHONDROPLASIA
    Medical condition: Achondroplasia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10000452 Achondroplasia LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) IT (Prematurely Ended) PT (Prematurely Ended) BE (Completed) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-001189-13 Sponsor Protocol Number: C4181005 Start Date*: 2021-02-26
    Sponsor Name:Pfizer Inc.
    Full Title: A PHASE 2 MULTIPLE DOSE, RANDOMIZED STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF RECIFERCEPT IN CHILDREN WITH ACHONDROPLASIA
    Medical condition: Achondroplasia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10000452 Achondroplasia LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: PT (Prematurely Ended) DK (Prematurely Ended) BE (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2022-002954-25 Sponsor Protocol Number: ASND0036 Start Date*: 2023-03-21
    Sponsor Name:Ascendis Pharma Growth Disorders A/S
    Full Title: ApproaCH: A Phase 2b, Multicenter, Double-Blind, Randomized, Placebo-controlled Trial evaluating Efficacy and Safety of Subcutaneous Doses of TransCon CNP Administered Once Weekly for 52 Weeks in C...
    Medical condition: Achondroplasia (ACH) in prepubertal children
    Disease: Version SOC Term Classification Code Term Level
    25.0 10010331 - Congenital, familial and genetic disorders 10000452 Achondroplasia LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: IE (Trial now transitioned) DK (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-002754-22 Sponsor Protocol Number: TCC-201 Start Date*: 2019-11-01
    Sponsor Name:Ascendis Pharma Growth Disorders A/S
    Full Title: ACcomplisH: A Phase 2, multicenter, double-blind, randomized, placebo-controlled, dose escalation trial evaluating safety, efficacy, and pharmacokinetics of subcutaneous doses of TransCon CNP admin...
    Medical condition: Achondroplasia (ACH) in prepubertal children
    Disease: Version SOC Term Classification Code Term Level
    25.0 100000004850 10000452 Achondroplasia LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: IE (Completed) GB (GB - no longer in EU/EEA) DE (Completed) AT (Completed) DK (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2017-000701-21 Sponsor Protocol Number: 111-901 Start Date*: 2017-06-19
    Sponsor Name:BioMarin Pharmaceutical Inc.
    Full Title: A Multicenter, Multinational Clinical Assessment Study for Pediatric Patients with Achondroplasia
    Medical condition: Achondroplasia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10000452 Achondroplasia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2005-003985-40 Sponsor Protocol Number: CZOL446G2422 Start Date*: 2006-01-09
    Sponsor Name:Department of Internal Medicine, University Hospital Gasthuisberg
    Full Title: A prospective multicentre phase II trial of zoledronic acid in patients with myelofibrosis with myeloid metaplasia (MMM)
    Medical condition: myelofibrosis with myeloid metaplasia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) ES (Completed) DE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-003212-22 Sponsor Protocol Number: 10MI30 Start Date*: 2013-06-03
    Sponsor Name:GOSH/ICH Joint Research & Development Office
    Full Title: Phase I study of ex-vivo lentiviral gene therapy for the inherited skin disease Netherton Syndrome
    Medical condition: Netherton Syndrome (NS)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10062909 Netherton's syndrome PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-004137-32 Sponsor Protocol Number: 111-202 Start Date*: 2014-04-03
    Sponsor Name:BioMarin Pharmaceutical Inc.
    Full Title: A Phase 2, Open-label, Sequential Cohort Dose-escalation Study of BMN 111 in Children with Achondroplasia
    Medical condition: achondroplasia
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004850 10000452 Achondroplasia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-002038-36 Sponsor Protocol Number: 48438 Start Date*: 2015-08-20
    Sponsor Name:Aarhus University Hospital, Department of Rheumatology U
    Full Title: Chronic non bacterial osteomyelitis treated with pamidronat in a randomised placebo controlled trial
    Medical condition: Chronic non bacterial osteomyelitis
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004862 10009081 Chronic osteomyelitis LLT
    Population Age: Children, Under 18, Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2015-004004-30 Sponsor Protocol Number: 111-205 Start Date*: Information not available in EudraCT
    Sponsor Name:BioMarin Pharmaceutical Inc.
    Full Title: A Phase 2, Open-Label, Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of BMN 111 in Children with Achondroplasia
    Medical condition: achondroplasia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10000452 Achondroplasia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-001855-15 Sponsor Protocol Number: QBGJ398-203 Start Date*: 2022-02-02
    Sponsor Name:QED Therapeutics, Inc.
    Full Title: Phase 2, Open-Label, Long-Term, Extension (OLE) Study of Infigratinib, an FGFR 1-3-Selective Tyrosine Kinase Inhibitor, in Children with Achondroplasia: PROPEL OLE
    Medical condition: Achondroplasia in Children
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10000452 Achondroplasia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-002404-28 Sponsor Protocol Number: 111-302 Start Date*: 2018-10-12
    Sponsor Name:BioMarin Pharmaceutical Inc.
    Full Title: A Phase 3, Open-Label Long-Term Extension Study to Evaluate the Safety and Efficacy of BMN 111 in Children with Achondroplasia
    Medical condition: Achondroplasia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10000452 Achondroplasia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Ongoing) DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-002954-21 Sponsor Protocol Number: QBGJ398-201 Start Date*: 2020-05-06
    Sponsor Name:QED Therapeutics, Inc.
    Full Title: Phase 2, Open-Label, Dose-Escalation and Dose-Expansion Study of Infigratinib, an FGFR 1-3-Selective Tyrosine Kinase Inhibitor, in Children with Achondroplasia: PROPEL 2
    Medical condition: Achondroplasia in Children
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10000452 Achondroplasia LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2021-003210-39 Sponsor Protocol Number: SXR001 Start Date*: 2021-11-23
    Sponsor Name:Sixera Pharma
    Full Title: A phase I/II, multicenter, randomized, double-blind, placebo within-patient controlled, first-time-in-man (FTIM) Proof of Concept (PoC) study to evaluate the safety and efficacy of topically applie...
    Medical condition: Netherton-syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10062909 Netherton's syndrome PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FI (Completed) SE (Trial now transitioned) AT (Trial now transitioned) DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003836-11 Sponsor Protocol Number: 111-301 Start Date*: 2017-01-20
    Sponsor Name:BioMarin Pharmaceutical Inc.
    Full Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BMN 111 in Children with Achondroplasia.
    Medical condition: achondroplasia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10000452 Achondroplasia LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-003227-15 Sponsor Protocol Number: KER050-MF-301 Start Date*: 2022-02-08
    Sponsor Name:Keros Therapeutics, Inc.
    Full Title: A Phase 2 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of KER-050 as Monotherapy or in Combination with Ruxolitinib in Participants with Myelofibrosis
    Medical condition: Myelfibrosis (MF) MF- associated cytopenias
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028537 Myelofibrosis PT
    20.0 100000004851 10002272 Anemia LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10074690 Post essential thrombocythemia myelofibrosis LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10074691 Post polycythaemia vera myelofibrosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned) FR (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-000917-38 Sponsor Protocol Number: CBPR277X2101 Start Date*: 2011-09-14
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A first–in-human study to evaluate safety and tolerability of repeated topical administrations of BPR277 ointment in healthy volunteers, and safety, tolerability, and preliminary efficacy of multip...
    Medical condition: Part 2: Atopic Dermatitis (AD) Part 3: Netherton Syndrome (NS)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004858 10003639 Atopic dermatitis LLT
    14.1 10010331 - Congenital, familial and genetic disorders 10062909 Netherton's syndrome PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) NL (Prematurely Ended)
    Trial results: View results
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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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