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Clinical trials for Heterotopic

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   44364   clinical trials with a EudraCT protocol, of which   7388   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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    12 result(s) found for: Heterotopic. Displaying page 1 of 1.
    EudraCT Number: 2014-001453-17 Sponsor Protocol Number: PVO-1A-201 Start Date*: 2015-07-07
    Sponsor Name:Clementia Pharmaceuticals Inc.
    Full Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of a RARγ-Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects with Fibrodysplasia O...
    Medical condition: Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) and abnormal heterotopic ossificat...
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-005035-33 Sponsor Protocol Number: R2477-FOP-1623 Start Date*: 2017-08-15
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: A randomized, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and effects on heterotopic bone formation of REGN2477 in patients with Fibrodysplasia Ossificans Progres...
    Medical condition: Fibrodysplasia Ossificans Progressiva (FOP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) NL (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2016-002526-36 Sponsor Protocol Number: PVO-1A-204 Start Date*: 2022-07-05
    Sponsor Name:Clementia Pharmaceuticals Inc.
    Full Title: A Phase 2, Open-Label, Efficacy and Safety Study of an RARγ-Specific Agonist (Palovarotene) to Prevent Heterotopic Ossification in Subjects with Fibrodysplasia Ossificans Progressiva (FOP)
    Medical condition: Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) and abnormal heterotopic ossificat...
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-002496-28 Sponsor Protocol Number: PVO-1A-202 Start Date*: 2015-11-13
    Sponsor Name:Clementia Pharmaceuticals Inc.
    Full Title: A Phase 2, Open-Label Extension, Efficacy and Safety Study of a RARγ-Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects with Fibrodysplasia Ossificans Progressiva ...
    Medical condition: Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) and abnormal heterotopic ossificat...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-013645-29 Sponsor Protocol Number: 120609 Start Date*: 2009-08-07
    Sponsor Name:Epsom & St Helier's University Hospital NHS Trust
    Full Title: A Two Phase Prospective Randomized Control Trial of Infiltrated Periarticular Multimodal Analgesia following Primary Total Hip Replacement
    Medical condition: Pain relief after total hip replacement
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2011-002516-85 Sponsor Protocol Number: 01-2011 Start Date*: 2011-10-20
    Sponsor Name:A.O. UNIVERSITARIA INTEGRATA DI VERONA
    Full Title: Open-label study to evaluate the efficacy and tolerability of orally administered rosiglitazone in patients with progressive bone Fibrodysplasia (FOP)
    Medical condition: Fibrodysplasia Ossificans Progressive (FOP) is a rare genetically based disability, characterized by progressive heterotopic ossification, usually associated with congenital malformation of the toes.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10028393 Musculoskeletal and connective tissue disorders NEC HLGT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-002541-29 Sponsor Protocol Number: PVO-1A-301 Start Date*: 2017-12-14
    Sponsor Name:Clementia Pharmaceuticals Inc
    Full Title: A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP)
    Medical condition: Fibrodysplasia Ossificans Progressiva (FOP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) SE (Completed) ES (Ongoing) DE (Completed) FR (Completed) NL (Ongoing) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2022-000880-40 Sponsor Protocol Number: R2477-FOP-2175 Start Date*: 2022-08-29
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: Phase 3 Randomized, Placebo-Controlled Study to Assess Safety, Tolerability, and Efficacy of Garetosmab in Patients with Fibrodysplasia Ossificans Progressiva
    Medical condition: Fibrodysplasia Ossificans Progressiva
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) FI (Trial now transitioned) IT (Trial now transitioned) NL (Ongoing) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-002858-24 Sponsor Protocol Number: D-CA-60130-452 Start Date*: 2021-12-17
    Sponsor Name:Clementia Pharmaceuticals Inc, an Ipsen Company
    Full Title: A Phase 2, two-part, placebo-controlled, parallel-group, double-blind study to assess the efficacy and safety of 2 dosage regimens of oral IPN60130 for the treatment of fibrodysplasia ossificans pr...
    Medical condition: fibrodysplasia ossificans progressiva (FOP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Ongoing) SE (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing) NL (Trial now transitioned) BE (Trial now transitioned) PT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-000431-32 Sponsor Protocol Number: ORTHOUNION Start Date*: 2017-05-25
    Sponsor Name:Universidad Autónoma de Madrid (U.A.M.)
    Full Title: A MULTI-CENTRE, OPEN-LABEL, RANDOMIZED, COMPARATIVE CLINICAL TRIAL OF TWO DIFFERENT DOSES OF BONE MARROW AUTOLOGOUS HUMAN MESENCHYMAL STEM CELLS PLUS BIOMATERIAL VERSUS ILIAC CREST AUTOLOGOUS GRAFT...
    Medical condition: Diaphyseal and/or metaphysodiaphyseal fractures (femur, tibia, humerus) with status of non-union
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10028395 Musculoskeletal and connective tissue disorders SOC
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10017085 Fracture malunion PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) DE (Completed) FR (Ongoing) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-004034-11 Sponsor Protocol Number: GR-OG-279239-04 Start Date*: 2022-05-18
    Sponsor Name:Genera Research Ltd
    Full Title: A randomized, evaluator-blinded, dose-ranging, proof of concept study of efficacy, safety and tolerability of Osteogrow-C (rhBMP6 delivered in autologous blood coagulum [ABC] supplemented with sy...
    Medical condition: The treatment of non-union of the tibia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10042613 Surgical and medical procedures SOC
    21.0 10028395 - Musculoskeletal and connective tissue disorders 10017088 Fracture nonunion PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-003324-20 Sponsor Protocol Number: STOPFOP1 Start Date*: 2020-01-08
    Sponsor Name:VU University Medical Center
    Full Title: Saracatinib trial TO Prevent FOP
    Medical condition: Fibrodyplasia Ossificans Progressiva (FOP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (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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