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Clinical trials for Capsid protein

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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    15 result(s) found for: Capsid protein. Displaying page 1 of 1.
    EudraCT Number: 2016-000925-38 Sponsor Protocol Number: UCL13/0076 Start Date*: 2017-01-04
    Sponsor Name:University College London (UCL)
    Full Title: GO-8: Gene therapy for haemophilia A using a novel serotype 8 capsid pseudotyped adeno-associated viral vector encoding Factor VIII-V3
    Medical condition: Severe Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060612 Hemophilia A LLT
    20.0 100000004850 10060613 Hemophilia A (Factor VIII) LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    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: 2014-001874-32 Sponsor Protocol Number: RDC-CNGA3-01 Start Date*: 2015-09-09
    Sponsor Name:Universitätsklinikum Tübingen
    Full Title: Safety and efficacy of a bilateral single subretinal injection of rAAV.hCNGA3 in adult and minor patients with CNGA3-linked achromatopsia investigated in a randomized, wait list controlled, observe...
    Medical condition: CNGA3-linked achromatopsia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10000454 Achromatopsia LLT
    Population Age: Children, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-005711-17 Sponsor Protocol Number: AGT4HB Start Date*: 2009-09-25
    Sponsor Name:St. Jude Children’s Research Hospital
    Full Title: AN OPEN LABEL DOSE-ESCALATION STUDY OF A SELF COMPLEMENTARY ADENO-ASSOCIATED VIRAL VECTOR (scAAV2/8-LP1-hFIXco) FOR GENE TRANSFER IN SUBJECTS WITH HEMOPHILIA B
    Medical condition: Gene therapy for Haemophilia B
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004865 10001140 Adeno-associated in vivo gene therapy LLT
    19.0 10010331 - Congenital, familial and genetic disorders 10061992 Haemophilia PT
    Population Age: Adults Gender: Male
    Trial protocol: GB (Temporarily Halted)
    Trial results: (No results available)
    EudraCT Number: 2013-005579-42 Sponsor Protocol Number: CT-AMT-060-01 Start Date*: 2015-03-20
    Sponsor Name:uniQure biopharma B.V.
    Full Title: A phase I/II, open-label, uncontrolled, single-dose, dose-ascending, multi-centre trial investigating an adeno-associated viral vector containing a codon-optimized human factor IX gene (AAV5-hFIX) ...
    Medical condition: Haemophilia B
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Completed) DK (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2017-004305-40 Sponsor Protocol Number: CSL222-3001 Start Date*: 2018-10-12
    Sponsor Name:CSL Behring LLC
    Full Title: Phase III, open-label, single-dose, multi-center multinational trial investigating a serotype 5 adeno-associated viral vector containing the Padua variant of a codon-optimized human factor IX gene ...
    Medical condition: Hemophilia B
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DK (Trial now transitioned) GB (GB - no longer in EU/EEA) IE (Trial now transitioned) NL (Trial now transitioned) DE (Trial now transitioned) BE (Trial now transitioned) SE (Trial now transitioned) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-004024-11 Sponsor Protocol Number: SHP648-101 Start Date*: 2020-05-04
    Sponsor Name:Baxalta Innovations GmbH
    Full Title: An Open-Label, Multinational, Phase 1/2 Study of the Safety and Dose Escalation of SHP648, an Adeno-Associated Virus Serotype 8 (AAV8) Vector Expressing FIX Padua in Hemophilia B Subjects
    Medical condition: Hemophilia B is a X-linked recessive bleeding disorder caused by mutations in the gene encoding clotting factor IX (FIX) that result in disruption of the normal clotting pathway. Hemophilia B affec...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Prematurely Ended) HU (Prematurely Ended) ES (Prematurely Ended) AT (Prematurely Ended) FR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-001079-18 Sponsor Protocol Number: FLT180a-06 Start Date*: 2022-04-27
    Sponsor Name:Freeline Therapeutics Ltd
    Full Title: A dose confirmation study of FLT180a (adeno-associated viral vector containing the Padua variant of a codon-optimized human Factor IX gene) in adult subjects with hemophilia B.
    Medical condition: Haemophilia B.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-004451-37 Sponsor Protocol Number: C3731003 Start Date*: 2021-09-24
    Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017
    Full Title: Phase 3, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of PF-07055480 (Recombinant AAV2/6 Human Factor VIII Gene Therapy) in Adult Male Participants with Moderately Severe to Sev...
    Medical condition: hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060613 Hemophilia A (Factor VIII) LLT
    Population Age: Adults Gender: Male
    Trial protocol: DE (Trial now transitioned) FR (Trial now transitioned) IT (Completed) ES (Restarted)
    Trial results: (No results available)
    EudraCT Number: 2013-002090-21 Sponsor Protocol Number: IM103177 Start Date*: 2016-02-02
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Evaluation of Acute Rejection Rates in de novo Renal Transplant Recipients Following Thymoglobulin Induction, CNI-free, Nulojix (belatacept) -based Immunosuppression
    Medical condition: Maintenance of renal transplant recipients.
    Disease: Version SOC Term Classification Code Term Level
    18.1 10021428 - Immune system disorders 10023439 Kidney transplant rejection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2019-001283-30 Sponsor Protocol Number: SPK-3006-101 Start Date*: 2020-06-16
    Sponsor Name:Spark Therapeutics
    Full Title: Phase 1/2, dose-escalation study to evaluate the safety, tolerability and efficacy of a single intravenous infusion of SPK-3006 in adults with late-onset Pompe disease
    Medical condition: Pompe Disease (also known as glycogen storage disease type II)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10053185 Glycogen storage disease type II PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) DE (Trial now transitioned) NL (Ongoing) DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2022-001157-23 Sponsor Protocol Number: GO44096 Start Date*: 2023-01-03
    Sponsor Name:F.Hoffmann-La Roche Ltd
    Full Title: A PHASE II, SINGLE-ARM, OPEN-LABEL STUDY EVALUATING THE SAFETY AND PHARMACOKINETICS OF THE INTRAVENOUS FIXED-DOSE COMBINATION (IV FDC) OF TIRAGOLUMAB AND ATEZOLIZUMAB IN PARTICIPANTS WITH LOCALLY A...
    Medical condition: Solid Tumors
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065252 Solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Trial now transitioned) CY (Trial now transitioned) ES (Ongoing) HR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-005229-95 Sponsor Protocol Number: PBKR03-001 Start Date*: 2021-08-23
    Sponsor Name:Passage Bio, Inc.
    Full Title: A Phase 1/2 Open-Label, Multicenter, Dose Ranging and Confirmatory Study to Assess the Safety, Tolerability and Efficacy of PBKR03 Administered to Pediatric Subjects with Early Infantile Krabbe Dis...
    Medical condition: Krabbe disease (globoid cell leukodystrophy) is an autosomal recessive lysosomal storage disease (LSD) caused by mutations in the gene encoding the hydrolytic enzyme galactosylceramidase (galactoce...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10023492 Krabbe's disease PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-005576-22 Sponsor Protocol Number: 201501 Start Date*: 2018-05-22
    Sponsor Name:BAXALTA INNOVATIONS GMBH
    Full Title: A Global, Open-Label, Multicenter, Phase 1/2 Study of the Safety and Dose Escalation of BAX 888, an Adeno-Associated Virus Serotype 8 (AAV8) Vector Expressing B-Domain Deleted Factor VIII (BDD-FVII...
    Medical condition: Hemophilia A is a rare congenital disease characterized by reduced or absent levels of the coagulation FVIII. It occurs in approximately 1 in 5,000 live male births. Mutations of the FVIII gene res...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060613 Hemophilia A (Factor VIII) LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-001271-23 Sponsor Protocol Number: C0371004 Start Date*: 2019-02-20
    Sponsor Name:Pfizer Inc.
    Full Title: AN OPEN-LABEL, NON-INVESTIGATIONAL PRODUCT, MULTI-CENTER, LEAD-IN STUDY TO EVALUATE PROSPECTIVE EFFICACY AND SELECTED SAFETY DATA OF CURRENT FACTOR IX (FIX) OR FACTOR VIII (FVIII) PROPHYLAXIS REPLA...
    Medical condition: Moderately Severe To Severe Adult Hemophilia B Participants (FIX:C≤2%) Who Are Negative For Neutralizing Antibodies (NAb) To Adeno-Associated Virus Vector (AAV) Spark100. Moderately severe to sever...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060614 Hemophilia B (Factor IX) LLT
    20.0 100000004850 10060613 Hemophilia A (Factor VIII) LLT
    Population Age: Adults Gender: Male
    Trial protocol: SE (Completed) GB (GB - no longer in EU/EEA) IE (Completed) DE (Completed) FR (Completed) ES (Ongoing) NL (Ongoing)
    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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