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Clinical trials for Recombinant antibodies

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   44334   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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    389 result(s) found for: Recombinant antibodies. Displaying page 1 of 20.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2010-023384-18 Sponsor Protocol Number: 730901 Start Date*: 2011-03-14
    Sponsor Name:Baxter Innovations GmbH
    Full Title: Randomized, double-blind, phase I/II clinical study to investigate the safety and immunogenicity of a multivalent recombinant OspA Lyme Borreliosis vaccine (mv rOspA LB Vaccine) in healthy subjects...
    Medical condition: -) To obtain safety and immunogenicity data of different dose levels of a mv rOspA LB Vaccine with and without adjuvant in seronegative healthy volunteers aged 18 to 70 years. The outcome shall pro...
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004862 10067559 Lyme borreliosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2005-000744-82 Sponsor Protocol Number: 1.1 Start Date*: 2005-06-16
    Sponsor Name:Medical University Vienna, Dept. of Clinical Pharmacology
    Full Title: Impact of rhCu/Zn SOD on inflammation-induced impairment of vascular reactivity
    Medical condition: 43 healthy male subjects, age 19-45 yrs. Nonsmokers
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2007-002984-28 Sponsor Protocol Number: CT-830-07-0047 Start Date*: 2008-01-23
    Sponsor Name:STADA R&D GmbH
    Full Title: Evaluation of the Therapeutic Equivalence of Two Different Formulations Containing Epoetin (Epoetin STADA vs. Erypo®) Administered Subcutaneously for the Maintenance Treatment of Renal Anaemia
    Medical condition: To prove the therapeutic equivalence of Epoetin STADA to a reference product (Erypo®) administered subcutaneously for maintaining the haemoglobin concentration in anaemic patients with end-stage re...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-002393-23 Sponsor Protocol Number: CSL627_1001 Start Date*: 2012-01-10
    Sponsor Name:CSL Behring GmbH
    Full Title: A Phase I/III Open-label, Multicenter, Crossover Safety, Efficacy and Pharmacokinetic Study of Recombinant Coagulation Factor VIII (rFVIII) Compared to Recombinant Factor VIII (rFVIII; INN: octocog...
    Medical condition: Hemophilia A.
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004850 10060612 Hemophilia A LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: DE (Completed) SE (Completed) AT (Completed) IT (Completed) PL (Completed) GB (Completed) ES (Completed) HU (Completed) NL (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2016-002230-69 Sponsor Protocol Number: V102_15E1 Start Date*: 2016-10-31
    Sponsor Name:GlaxoSmithKline Biologicals S.A.
    Full Title: A Phase 2b, Open-Label, Multi-Center Study Assessing the Immunological Persistence of Antibodies at Approximately 2 years After the last Meningococcal Vaccination in Study V102_15 and the Response ...
    Medical condition: Meningococcal diseases
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10027202 Meningitis bacterial PT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2020-002215-22 Sponsor Protocol Number: LTS16294 Start Date*: 2021-06-03
    Sponsor Name:Bioverativ Therapeutics Inc.
    Full Title: A Phase 3 open-label, multicenter study of the long-term safety and efficacy of intravenous recombinant coagulation factor VIII Fc-von willebrand factor-XTEN fusion protein (rFVIIIFc-VWF-XTEN; BIVV...
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060612 Hemophilia A LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) FR (Trial now transitioned) GR (Trial now transitioned) IE (Trial now transitioned) SE (Trial now transitioned) HU (Trial now transitioned) DE (Trial now transitioned) BG (Trial now transitioned) IT (Trial now transitioned) NL (Trial now transitioned)
    Trial results: (No results available)
    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: 2019-004461-41 Sponsor Protocol Number: MET59 Start Date*: 2020-02-14
    Sponsor Name:Sanofi Pasteur Inc
    Full Title: Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adolescents and Adults
    Medical condition: Healthy volunteers (active immunization against invasive meningogoccal disease (IMD) caused by Meningococcal serogroups A, C, Y and W)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10027274 Meningococcal infection PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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: 2020-004741-37 Sponsor Protocol Number: 212458 Start Date*: 2021-06-21
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase I/II, randomised, controlled study to assess the safety, effectiveness and immune response of meningococcal combined ABCWY vaccine when administered to healthy adults (Phase I) and to healt...
    Medical condition: Healthy volunteers (Active immunization against IMD caused by Neisseria Meningitidis (N.meningitidis) serogroups A, B, C, W and Y)
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed) FI (Completed) Outside EU/EEA PL (Completed) SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2023-000924-13 Sponsor Protocol Number: VAN00010 Start Date*: 2023-12-21
    Sponsor Name:Sanofi Pasteur Inc.
    Full Title: A Phase I/II, Randomized, Descriptive, Safety and Immunogenicity study to assess Pentavalent Meningococcal ABCYW Vaccine formulations in Adults (18 to 25 years of age) and Adolescents (10 to 17 yea...
    Medical condition: Bacterial infections and mycoses
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10027274 Meningococcal infection PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2014-005477-37 Sponsor Protocol Number: 261303 Start Date*: 2016-01-26
    Sponsor Name:Baxalta Innovations GmbH
    Full Title: Phase 3, prospective, randomized, multi-center clinical study comparing the safety and efficacy of BAX 855 following PK-guided prophylaxis targeting two different FVIII trough levels in subjects wi...
    Medical condition: Severe hemophilia A (FVIII <1%)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000011915 10060612 Hemophilia A LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) AT (Completed) SE (Completed) CZ (Prematurely Ended) ES (Completed) HU (Completed) BG (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-005350-79 Sponsor Protocol Number: NN028-1801 Start Date*: Information not available in EudraCT
    Sponsor Name:Novo Nordisk A/S
    Full Title: A single arm, single-centre, open-label, exploratory trial of recombinant Interleukin-21 administered subcutaneously for 4 weeks as neo-adjuvant treatment prior to sentinel lymph node/complete lymp...
    Medical condition: Recombinant Interleukin-21 administered subcutaneously for 4 weeks as neo-adjuvant treatment prior to sentinel lymph node/complete lymph node dissection followed by 8 weeks of adjuvant treatment in...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10025670 Malignant melanoma stage III LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-000413-39 Sponsor Protocol Number: 251002 Start Date*: 2011-10-06
    Sponsor Name:Baxter Innovations GmbH
    Full Title: BAX 326 (recombinant factor IX): A Phase 3 Prospective, Multicenter Study Evaluating Efficacy and Safety in Previously Treated Patients With Severe (FIX level < 1%) or Moderately Severe (FIX level ...
    Medical condition: Previously treated patients with severe (FIX level < 1%) or moderately severe (FIX level ≤ 2%) hemophilia B undergoing surgical or other invasive procedures
    Disease: Version SOC Term Classification Code Term Level
    14.1 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) CZ (Completed) SE (Completed) BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2011-002667-14 Sponsor Protocol Number: UHKT-RLP/2011 Start Date*: 2011-07-19
    Sponsor Name:Institute of Hematology and Blood Transfusion
    Full Title: Effect of vaccination in patients with recurrent respiratory papillomatosis– can we improve the quality of life of these patients?
    Medical condition: Recurrent respiratory papillomatosis
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10023849 Laryngeal papilloma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2005-001621-29 Sponsor Protocol Number: 80804002 Start Date*: 2009-05-05
    Sponsor Name:Faculty of Medicine Carl Gustav Carus, University of Technology, Dresden
    Full Title: Pre-POINT (Primary Oral INsulin Trial) study A dose finding safety and immune efficacy study for primary mucosal insulin therapy in islet autoantibody negative children at high genetic risk for ty...
    Medical condition: pre-type 1 diabetes (islet autoimmunity in non-diabetic relatives of subjects with type 1 diabetes)
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-001429-30 Sponsor Protocol Number: WA42294 Start Date*: 2021-03-15
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF)
    Medical condition: Idiopathic pulmonary fibrosis (IPF)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10021240 Idiopathic pulmonary fibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) CZ (Completed) DE (Prematurely Ended) SE (Prematurely Ended) GR (Prematurely Ended) HU (Completed) PT (Prematurely Ended) AT (Prematurely Ended) FI (Completed) NO (Completed) DK (Prematurely Ended) PL (Completed) NL (Completed) BE (Completed) IT (Prematurely Ended)
    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: 2011-006032-23 Sponsor Protocol Number: CSL654_3002 Start Date*: 2012-07-20
    Sponsor Name:CSL Behring GmbH
    Full Title: A Phase III Open-label, Multicenter, Pharmacokinetics, Safety, and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) in Previously Treated Children ...
    Medical condition: Prophylaxis and treatment of bleeding episodes in previously treated children with congenital FIX deficiency (hemophilia B)
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004850 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: AT (Completed) ES (Completed) CZ (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-003135-36 Sponsor Protocol Number: CYD67 Start Date*: 2019-10-31
    Sponsor Name:Sanofi Pasteur SA
    Full Title: Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially with Gardasil® in Healthy Subjects Aged 9 to 13 Years in Malaysia
    Medical condition: Dengue Fever Dengue Hemorrhagic Fever Human Papillomavirus Disease
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
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