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Clinical trials for Mecasermin

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  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    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 ).  
     
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    16 result(s) found for: Mecasermin. Displaying page 1 of 1.
    EudraCT Number: 2004-000644-25 Sponsor Protocol Number: INSM-110-303 Start Date*: 2004-07-09
    Sponsor Name:Insmed Incorporated
    Full Title: A Phase II/III, Open-Label, Multi-Center Clinical Trial to Evaluate the Safety and Efficacy of Insulin-Like Growth Factor I/ Insulin-Like Growth Factor Binding Protein-3 (rhIGF-I/rhIGFBP-3), Admini...
    Medical condition: Growth Hormone Insensitivity Syndrome (GHIS) is a genetically disturbance of the biological action of growth hormone (GH). This study is intended to evaluate the ability of rhIGF-I/rhIGFBP-3 to de...
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SK (Completed) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-001095-11 Sponsor Protocol Number: MS308 Start Date*: 2019-05-31
    Sponsor Name:Ipsen Pharma
    Full Title: RECOMBINANT HUMAN INSULIN-LIKE GROWTH FACTOR-1 (rhIGF-1) TREATMENT OF SHORT STATURE ASSOCIATED WITH PRIMARY IGF-1 DEFICIENCY: A MULTICENTER, OPEN-LABEL, CONCENTRATION-CONTROLLED TRIAL
    Medical condition: Children with growth failure associated with primary insulin-like growth factor deficiency (IGFD).
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-000844-81 Sponsor Protocol Number: MS306 Start Date*: 2019-05-31
    Sponsor Name:Ipsen Pharma
    Full Title: RECOMBINANT HUMAN INSULIN-LIKE GROWTH FACTOR-1 (rhIGF-1) TREATMENT OF CHILDREN AND ADOLESCENTS WITH GROWTH FAILURE ASSOCIATED WITH PRIMARY IGF-1 DEFICIENCY: AN OPEN-LABEL, MULTI-CENTER, EXTENSION S...
    Medical condition: Children and adolescents with growth failure associated with primary insulin-like growth factor deficiency (IGFD).
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-002500-34 Sponsor Protocol Number: ROPP-2005-01 Start Date*: 2006-08-31
    Sponsor Name:Ann Hellström
    Full Title: A Phase I, Open-Label, Pharmacokinetic, Single-Center, Dose Evaluation Study to Determine the Dose of rhIGF-I/rhIGFBP-3 required to Increase Serum IGF-I levels to Physiological Levels in Premature ...
    Medical condition: Premature male/female infants, between 26 weeks ±0 days and 29 weeks +6 days at birth, in risk of developing ROP, retinopathy of prematurity.
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-001393-16 Sponsor Protocol Number: SHP607-202 Start Date*: 2019-06-21
    Sponsor Name:Premacure AB
    Full Title: A Phase 2b, Multicenter, Randomized, Open-label, Controlled, 3-Arm Study to Evaluate the Clinical Efficacy and Safety of SHP607 in Preventing Chronic Lung Disease Through 12 Months Corrected Age Co...
    Medical condition: Chronic Lung Disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004855 10066204 Chronic lung disease of prematurity LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IE (Trial now transitioned) SE (Prematurely Ended) FR (Completed) DE (Trial now transitioned) PT (Trial now transitioned) ES (Temporarily Halted) FI (Trial now transitioned) NL (Trial now transitioned) PL (Prematurely Ended) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-001020-36 Sponsor Protocol Number: MS301 Start Date*: 2019-05-31
    Sponsor Name:Ipsen Pharma
    Full Title: RECOMBINANT HUMAN INSULIN-LIKE GROWTH FACTOR-1 (rhIGF-1) TREATMENT OF PREPUBERTAL CHILDREN WITH GROWTH FAILURE ASSOCIATED WITH PRIMARY IGF-1 DEFICIENCY: A PHASE 3, RANDOMIZED, OPEN LABEL, OBSERVATI...
    Medical condition: Children with growth failure associated with primary insulin-like growth factor deficiency (IGFD).
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-000843-29 Sponsor Protocol Number: MS316 Start Date*: 2019-05-31
    Sponsor Name:Ipsen Pharma
    Full Title: Recombinant Human Growth Hormone (rhGH) and Recombinant Human Insulin-like Growth Factor-1 (rhIGF-1) Combination Therapy in Children with Short Stature Associated with IGF-1 Deficiency: A Six-year,...
    Medical condition: Idiopatic Short Stature in prepubertal children associated with low IGF-1 and normal stimulated GH response
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-002726-84 Sponsor Protocol Number: SHP607-203 Start Date*: Information not available in EudraCT
    Sponsor Name:Premacure AB
    Full Title: Long-Term Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment with SHP607 in Extremely Premature Infants
    Medical condition: Chronic Lung Disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004855 10066204 Chronic lung disease of prematurity LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-004104-38 Sponsor Protocol Number: ARPA-IGF1-2011 Start Date*: 2012-02-17
    Sponsor Name:FIBHULP
    Full Title:
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10017374 Friedreich's ataxia PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-000480-27 Sponsor Protocol Number: UCC-IGF-001 Start Date*: 2011-06-03
    Sponsor Name:University College Cork
    Full Title: A Randomised Trial Evaluating the Safety and Efficacy of a Single Low Dose of Intracoronary Insulin-like Growth Factor-1 Following Percutaneous Coronary Intervention for ST-Elevation Acute Myocardi...
    Medical condition: ST Elevation Myocardial Infarction
    Disease: Version SOC Term Classification Code Term Level
    17.1 10007541 - Cardiac disorders 10000891 Acute myocardial infarction PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2007-007872-40 Sponsor Protocol Number: ROPP-2008-01 Start Date*: 2014-08-19
    Sponsor Name:Premacure AB, A member of the Shire Group of Companies
    Full Title: Determination of the rhIGF-I/rhIGFBP-3 Dose; Administered as a Continuous Infusion, Required to Establish and Maintain Longitudinal Serum IGF-I Levels within Physiological Levels in Premature Infan...
    Medical condition: Retinopathy of Prematurity (ROP)
    Disease: Version SOC Term Classification Code Term Level
    17.1 10015919 - Eye disorders 10015919 Eye disorders SOC
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) GB (Completed) IT (Completed) NL (Prematurely Ended) PL (Completed)
    Trial results: View results
    EudraCT Number: 2014-003556-31 Sponsor Protocol Number: SHP-607-201 Start Date*: 2015-02-10
    Sponsor Name:Premacure AB, A Member of the Shire Group of Companies
    Full Title: Long-term Outcome of Children Enrolled in Study ROPP-2008-01 Previously Treated with rhIGF-1/rhIGFBP-3 for the Prevention of Retinopathy of Prematurity (ROP) or Who Received Standard Neonatal Care
    Medical condition: Retinopathy of Prematurity (ROP)
    Disease:
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) GB (GB - no longer in EU/EEA) NL (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-001239-30 Sponsor Protocol Number: CIR976101 Start Date*: 2012-05-22
    Sponsor Name:Foundation for Liver Research
    Full Title: THE EFFECTS OF RECOMBINANT HUMAN INSULIN-LIKE GROWTH FACTOR-1 ON THE NUTRITIONAL STATUS IN PATIENTS WITH LIVER CIRRHOSIS: A PILOT-STUDY.
    Medical condition: Liver cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10019805 - Hepatobiliary disorders 10024667 Liver cirrhosis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-022215-19 Sponsor Protocol Number: GHIGF1/2011 Start Date*: 2011-07-21
    Sponsor Name:Greater Glasgow & Clyde NHS
    Full Title: A Pharmacokinetic Study Of The Combined Use Of Recombinant Human GH And IGF-1 In Children With Inflammatory Bowel (Crohn’s) Disease
    Medical condition: Impaired growth in Paediatric Crohn's disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004856 10011398 Crohn's LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-002719-27 Sponsor Protocol Number: GLU2011FC Start Date*: 2011-12-30
    Sponsor Name:AZIENDA OSPEDALIERA DI PARMA
    Full Title: GLUCOSE METABOLISM AND INFLAMMATORY PARAMETERS UNDER IGF-I TREATMENT IN CYSTIC FIBROSIS
    Medical condition: PATIENTS WITH CYSTIC FIBROSIS
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10011766 Cystic fibrosis pancreatic PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2010-020742-10 Sponsor Protocol Number: 8-79-52800-011 Start Date*: 2011-05-09
    Sponsor Name:Ipsen Pharma
    Full Title: Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Ye...
    Medical condition: Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency
    Disease: Version SOC Term Classification Code Term Level
    12.1 10056438 Growth hormone deficiency LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) SE (Prematurely Ended) FI (Prematurely Ended) ES (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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