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Clinical trials for Recombinant proteins

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 ).  
     
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    53 result(s) found for: Recombinant proteins. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2017-002574-39 Sponsor Protocol Number: 207811 Start Date*: 2018-11-08
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: Ancillary study evaluating ChAd155-hIi-HBV shedding in a subset of chronic hepatitis B patients enrolled in the first-time-in-human, Phase I/II, randomised, multi-centric, single-blind study TH HBV...
    Medical condition: Chronic hepatitis B
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10008910 Chronic hepatitis B PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    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: 2017-001452-55 Sponsor Protocol Number: 204852 Start Date*: 2018-11-26
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A first-time-in human (FTIH), Phase I/II, randomized, multi-centric, single-blind, controlled dose-escalation study to evaluate the reactogenicity, safety, immunogenicity and efficacy of GSK Biolog...
    Medical condition: Chronic hepatitis B
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10008910 Chronic hepatitis B PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-003111-31 Sponsor Protocol Number: 2007-1-18-20-6 Start Date*: 2008-07-21
    Sponsor Name:Charité - Universitaetsmedizin Berlin
    Full Title: Influence of postoperative influenza vaccination versus GM-CSF in immune-compromised patients undergoing pancreatic or esophageal resection on the course of immunosuppression and the postoperative ...
    Medical condition: Post-operative immunological stimulation in severe immune suppression. The study population is made up of adult, which are able to give their inform consent by their own. The patients are undergoin...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2010-022726-33 Sponsor Protocol Number: 251001 Start Date*: 2011-03-24
    Sponsor Name:Baxter Innovations GmbH
    Full Title: BAX326 (recombinant Factor IX): Evaluation of Safety, Immunogenicity, and Hemostatic Efficacy in Previously Treated Patients with Severe (FIX level < 1%) or Moderately Severe (FIX level 1- 2%) Hemo...
    Medical condition: Previously treated patients (PTPs) with severe (FIX level < 1%) or moderately severe (FIX level 1- 2%) hemophilia B.
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004850 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BG (Completed) CZ (Completed) GB (Completed) DE (Prematurely Ended) SE (Completed) PL (Completed) ES (Completed) IT (Completed) IE (Completed)
    Trial results: View results
    EudraCT Number: 2011-002437-19 Sponsor Protocol Number: 251101 Start Date*: 2011-10-28
    Sponsor Name:Baxter Innovations GmbH
    Full Title: BAX326 (RECOMBINANT FACTOR IX): A PHASE 2/3 PROSPECTIVE, UNCONTROLLED, MULTICENTER STUDY EVALUATING PHARMACOKINETICS, EFFICACY, SAFETY, AND IMMUNOGENICITY IN PREVIOUSLY TREATED PEDIATRIC PATIENTS W...
    Medical condition: Pediatric previously treated patients (PTPs) with severe (FIX level < 1%) or moderately severe (FIX level ≤ 2%) hemophilia B.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2005-001693-27 Sponsor Protocol Number: 05/Q1606/30 Start Date*: 2005-06-24
    Sponsor Name:Oxford Radcliffe Hospitals NHS Trust
    Full Title: Pilot Effectiveness of Randomised Mandatory Insulin Therapy
    Medical condition: Those admitted to the Intensive Care Unit for treatment and likely to remain on the unit for longer than 5 days.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    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: 2022-002520-13 Sponsor Protocol Number: 251602 Start Date*: 2022-07-18
    Sponsor Name:Baxalta Innovations GmbH
    Full Title: Phase IV Multi-center, Prospective, Interventional, Post-marketing Study in Hemophilia B Patients in India receiving RIXUBIS as On-demand or Prophylaxis Under Standard Clinical Practice
    Medical condition: Hemophilia B
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-000126-38 Sponsor Protocol Number: OVG2012/05 Start Date*: 2014-04-08
    Sponsor Name:University of Oxford
    Full Title: Towards improved meningococcal vaccines: a randomised, descriptive, open label study exploring the relationship between gene expression signatures with reactogenicity and immunogenicity following v...
    Medical condition: This study aims to investigate gene expression following vaccination with 4CMenB and relate this to vaccine reactions and to immune response
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-003262-13 Sponsor Protocol Number: CSL627_3001 Start Date*: 2014-09-30
    Sponsor Name:CSL Behring GmbH
    Full Title: A Phase III Open Label, Multicenter, Extension Study to Assess the Safety and Efficacy of Recombinant Coagulation Factor VIII (rVIII-SingleChain, CSL627) in Subjects with Severe Hemophilia A
    Medical condition: Hemophilia A Severe hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004850 10060613 Hemophilia A (Factor VIII) LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: IT (Completed) GB (GB - no longer in EU/EEA) DE (Completed) CZ (Completed) HU (Completed) ES (Completed) NL (Completed) AT (Completed) PL (Completed) PT (Completed) IE (Completed)
    Trial results: View results
    EudraCT Number: 2016-004974-16 Sponsor Protocol Number: IL1ra03 Start Date*: 2018-11-08
    Sponsor Name:Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
    Full Title: DOUBLE-BLIND PLACEBO-CONTROLLED RANDOMISED CLINICAL DOSE-RANGING STUDY TREATING MODERATE-SEVERE TRAUMATIC BRAIN INJURY PATIENTS WITH RECOMBINANT HUMAN INTERLEUKIN 1 RECEPTOR ANTAGONIST.
    Medical condition: We wish to study the drug Kineret in patients suffering from moderate-to-severe traumatic brain injury
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004863 10060690 Traumatic brain injury LLT
    20.1 10029205 - Nervous system disorders 10051288 Central nervous system inflammation PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-007789-51 Sponsor Protocol Number: B1971005(6108A1-2001-WW) Start Date*: 2009-03-23
    Sponsor Name:Pfizer Inc
    Full Title: A Randomized, Single-Blind, Placebo-Controlled, Phase 2 Trial of the Safety, Immunogenicity, and Tolerability of Meningococcal Serogroup B (MnB) rLP2086 Vaccine at Doses of 60 µg, 120 µg, and 200 µ...
    Medical condition: The test is a vaccine. The subjects are healthy adolescents.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10027202 Meningitis bacterial PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: PL (Completed) ES (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-021373-37 Sponsor Protocol Number: HUBIN_L_05335 Start Date*: 2010-09-15
    Sponsor Name:Sanofi-Aventis Recherche et Développement
    Full Title: Evaluation of Insuman Implantable 400 IU/ml in patients with Type 1 diabetes treated with the Medtronic MiniMed Implantable Pump System using Insuplant 400 IU/mL
    Medical condition: Type 1 diabetes
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed) NL (Completed) SE (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2014-003880-38 Sponsor Protocol Number: 270-201 Start Date*: 2015-06-01
    Sponsor Name:BioMarin Pharmaceutical Inc.
    Full Title: A Phase 1/2, Dose-Escalation Safety, Tolerability and Efficacy Study of BMN 270, an Adenovirus-Associated Virus Vector–Mediated Gene Transfer of Human Factor VIII in Patients with Severe Haemophilia A
    Medical condition: Haemophilia A
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2009-016720-31 Sponsor Protocol Number: 250901 Start Date*: 2010-06-09
    Sponsor Name:Baxter Innovations GmbH [...]
    1. Baxter Innovations GmbH
    2. Baxter Healthcare Corporation
    Full Title: BAX 326 (recombinant Factor IX): A Phase 1/3 Prospective, Controlled, Multicenter Study Evaluating Pharmacokinetics, Efficacy, Safety, Immunogenicity in Previously Treated Patients with Severe (FIX...
    Medical condition: Previously treated patients with severe (FIX level < 1%) or moderately severe (FIX level ≤ 2%) hemophilia B.
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) CZ (Completed) ES (Completed) BG (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2007-006657-63 Sponsor Protocol Number: 0881K1-4500-EU (B1801016) Start Date*: 2009-05-08
    Sponsor Name:Pfizer Ltd., Ramsgate Road,Sandwich,Kent,CT13 9NJ,United Kingdom
    Full Title: Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA).
    Medical condition: Rheumatoid Arthritis (RA) patients who are on Etanercept (ETN) treatment and are in remission or in a Low Disease Activity (LDA) state
    Disease: Version SOC Term Classification Code Term Level
    14.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) SE (Completed) DK (Completed) HU (Completed) IS (Completed)
    Trial results: View results
    EudraCT Number: 2017-003902-42 Sponsor Protocol Number: GePKHIS Start Date*: 2018-03-08
    Sponsor Name:Consorzio Futuro in Ricerca
    Full Title: F9 Genotype and PK Hemophilia B International Study
    Medical condition: Deficiency of coagulation factor IX (FIX; Hemophilia B); Hemophilia B patients treated with recombinant FIX (BeneFIX).
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10053752 Hemophilia B with anti factor IX LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-001923-30 Sponsor Protocol Number: TN-20 Start Date*: 2016-09-26
    Sponsor Name:TRIALNET COORDINATING CENTER AT THE UNIVERSITY OF SOUTH FLORIDA
    Full Title: Exploring Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus
    Medical condition: Type 1 Diabetes
    Disease: Version SOC Term Classification Code Term Level
    21.1 10042613 - Surgical and medical procedures 10066284 Diabetes prophylaxis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-002454-78 Sponsor Protocol Number: V72_62 Start Date*: 2014-02-18
    Sponsor Name:Novartis Vaccines and Diagnostics S.r.l.
    Full Title: A Phase IIIb, Open Label, Controlled, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of Novartis Meningococcal Group B Vaccine when administered to Immunoco...
    Medical condition: Meningococcal Group B disease.
    Disease: Version SOC Term Classification Code Term Level
    16.1 10021881 - Infections and infestations 10027202 Meningitis bacterial PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed) ES (Completed) PL (Completed)
    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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