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Clinical trials for Primary Immunodeficiency Disease

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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    285 result(s) found for: Primary Immunodeficiency Disease. Displaying page 1 of 15.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2006-006522-25 Sponsor Protocol Number: ZLB06_005CR Start Date*: 2007-02-01
    Sponsor Name:CSL Behring AG
    Full Title: A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID)
    Medical condition: Patients with PID diseases as Common Variable Immunodeficiency (CVID) or X-linked agammaglobulinemia ( XLA), age 1 to 70 years
    Disease: Version SOC Term Classification Code Term Level
    8.1 10010112 Common variable immunodeficiency LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Prematurely Ended) BE (Completed) GR (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2005-002437-13 Sponsor Protocol Number: TMC114-C226 Start Date*: 2006-05-09
    Sponsor Name:Tibotec Pharmaceuticals Ltd.
    Full Title: Early access of TMC114 in combination with low-dose ritonavir (RTV) and other antiretrovirals (ARVs) in highly treatment experienced HIV-1 infected subjects with limited to no treatment options.
    Medical condition: HIV-1 infected patient
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020161 HIV infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-006188-35 Sponsor Protocol Number: IMMUNEF Start Date*: 2009-01-29
    Sponsor Name:AZIENDA OSPEDALIERA SAN GERARDO DI MONZA
    Full Title: Immunological efficacy of efavirenz based treatment in HIV-positive naive patients (a pylot study)
    Medical condition: HIV infection
    Disease: Version SOC Term Classification Code Term Level
    9.1 10052740 Acquired immunodeficiency syndromes HLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-001681-16 Sponsor Protocol Number: Break Start Date*: 2006-06-06
    Sponsor Name:FONDAZIONE NADIR ONLUS
    Full Title: A pilot, open label, randomised clinical trial assessing the 12 week immunological response in HIV-1 failing subjects receiving monotherapy with emtricitabine 200 mg once a day or emtricitabine 200...
    Medical condition: HIV-Infection
    Disease: Version SOC Term Classification Code Term Level
    6.1 10000565 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-017013-29 Sponsor Protocol Number: TMC114-TiDP29-C232 Start Date*: 2010-07-08
    Sponsor Name:Janssen R&D Ireland
    Full Title: Continued access to darunavir/ritonavir (DRV/rtv) in HIV-1 infected children and adolescents aged 3 years and above
    Medical condition: HIV-1
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10020161 HIV infection PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-000526-48 Sponsor Protocol Number: A.S.T.R.A. Start Date*: 2007-03-06
    Sponsor Name:AZIENDA OSPEDALIERA POLICLINICO DI MODENA
    Full Title: Randomized, monocentric trial on sintoms, adherence,toxicity of alternate antiretrovirale regimen
    Medical condition: PT HIV-1 positive and naive to antiretroviral drug
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020161 HIV infection LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-006212-30 Sponsor Protocol Number: IMIRC1002 Start Date*: 2007-08-09
    Sponsor Name:Imperial College London
    Full Title: A Randomised, Open labelled, Phase II, Immunogenicity, and Exploratory Efficacy Evaluation of Therapeutic Immunisations +/- IL-2, GM-CSF and Growth Hormone in HIV-1 Infected Subjects Receiving High...
    Medical condition: HIV-1
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020161 HIV infection LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-007200-16 Sponsor Protocol Number: ISS T-002 Start Date*: 2008-06-13
    Sponsor Name:ISTITUTO SUPERIORE DI SANITA'
    Full Title: A Phase II randomized, open label, immunogenicity and safety trial of the vaccine based on the recombinant biologically active HIV-1 Tat protein in anti-Tat negative HIV-1 infected HAART-treated ad...
    Medical condition: HIV-1 infected subjects
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020161 HIV infection LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-001058-26 Sponsor Protocol Number: P04285 Start Date*: 2006-01-09
    Sponsor Name:Schering-Plough Research Institute
    Full Title: Vicriviroc (SCH 417690) in Combination Treatment with Optimized ART Regimen in Experienced Subjects (VICTOR-E2)
    Medical condition: HIV infection (mixed X4/R5 torpism) with previous therapy
    Disease: Version SOC Term Classification Code Term Level
    10020172 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) PT (Prematurely Ended) DE (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-005015-82 Sponsor Protocol Number: NGAM-05 Start Date*: 2012-01-10
    Sponsor Name:Octapharma AG
    Full Title: Clinical study to evaluate the safety and tolerability of immunoglobulin intravenous (human) 10% (NewGam) administered at high infusion rates to patients with primary immunodeficiency diseases (ext...
    Medical condition: primary immunodeficiency diseases
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10049485 Bruton's agammaglobulinemia LLT
    14.1 10021428 - Immune system disorders 10010112 Common variable immunodeficiency LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2004-004465-15 Sponsor Protocol Number: Study No. 957 Start Date*: 2005-04-05
    Sponsor Name:Biotest AG
    Full Title: A multicentre, open, prospective study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT681 in patients wi...
    Medical condition: primary immunodeficiency syndrome as congenital agammaglobulinaemia or hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiencies, Wiskott Aldrich syndrome
    Disease: Version SOC Term Classification Code Term Level
    7.0 10036700 HLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2006-003881-32 Sponsor Protocol Number: 023-01 Start Date*: 2007-09-20
    Sponsor Name:Merck & Co, Inc
    Full Title: Early Access of MK-0518 in Combination With an Optimized Background Antiretroviral Therapy (OBT) in Highly Treatment Experienced HIV-1 Infected Patients With Limited to No Treatment Options.
    Medical condition: HIV-1 infected patients
    Disease: Version SOC Term Classification Code Term Level
    8.1 10020161 HIV infection LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) FI (Completed) ES (Completed) DE (Completed) SE (Prematurely Ended) AT (Completed) NL (Completed) LV (Completed) IT (Completed) EE (Completed) SI (Completed) IE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2009-013126-16 Sponsor Protocol Number: TMC125-TiDP35-C239 Start Date*: 2009-11-09
    Sponsor Name:Tibotec Pharmaceuticals c/o Tibotec BVBA
    Full Title: Continued access to etravirine in treatment experienced HIV-1 infected children and adolescents.
    Medical condition: HIV-1 Infection
    Disease: Version SOC Term Classification Code Term Level
    12.0 10020192 HIV-1 LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Ongoing) ES (Ongoing) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-002647-25 Sponsor Protocol Number: TMC278-TiDP6-C215 Start Date*: 2007-12-18
    Sponsor Name:Tibotec Pharmaceuticals
    Full Title: A Phase III, randomized, double-blind trial of TMC278 25 mg q.d. versus efavirenz 600 mg q.d. in combination with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhib...
    Medical condition: HIV infection
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020161 HIV infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) FR (Completed) PT (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-023483-41 Sponsor Protocol Number: I10E-0718 Start Date*: 2011-03-01
    Sponsor Name:LFB BIOTECHNOLOGIES
    Full Title: A MULTICENTER STUDY ON THE EFFICACY, SAFETY AND PHARMACOKINETICS OF I10E IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY (PID)
    Medical condition: a primary immunodeficiency as defined by the ESID and validated by a reference centre : • X-linked agammaglobulinemia (XLA) • Common variable immunodeficiency (CVID)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004870 10010112 Common variable immunodeficiency LLT
    14.1 100000004870 10036700 Primary immunodeficiency syndromes HLT
    14.1 100000004870 10001471 Agammaglobulinemia LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) FR (Completed) Outside EU/EEA
    Trial results: Removed from public view
    EudraCT Number: 2008-004631-37 Sponsor Protocol Number: TMC114-TiDP29-C230 Start Date*: 2009-06-25
    Sponsor Name:Tibotec Pharmaceuticals
    Full Title: A Phase II, open-label trial, to evaluate pharmacokinetics, safety, tolerability and antiviral activity of DRV/rtv once daily in treatment-naïve HIV 1 infected adolescents aged between 12 and < 18 ...
    Medical condition: HIV-1
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020161 HIV infection LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IE (Completed) GB (Completed) FR (Completed) ES (Completed) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-001287-23 Sponsor Protocol Number: TMC125-C217 Start Date*: 2006-06-13
    Sponsor Name:Tibotec Pharmaceuticals Limited
    Full Title: An open-label trial with TMC125 as part of an ART including TMC114/rtv and an investigator-selected OBR in HIV-1 infected subjects who participated in a DUET trial (TMC125-C206 or TMC125-C216).
    Medical condition: HIV-1 infection
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020192 HIV-1 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) ES (Completed) FR (Completed) IT (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2006-004306-50 Sponsor Protocol Number: A4001050 Start Date*: 2007-04-23
    Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017
    Full Title: A MULTI-CENTER, OPEN LABEL, EXPANDED ACCESS TRIAL OF MARAVIROC
    Medical condition: HIV
    Disease: Version SOC Term Classification Code Term Level
    8.1 10020192 HIV-1 LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) GB (Completed) BE (Completed) CZ (Completed) DE (Completed) PT (Completed) ES (Completed) NL (Completed) AT (Completed) GR (Completed) IT (Completed) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-000793-45 Sponsor Protocol Number: TMC114-C209 Start Date*: Information not available in EudraCT
    Sponsor Name:Tibotec Pharmaceuticals Ltd.
    Full Title: Open-label safety study of TMC114 in combination with low dose RTV and other ARVs in highly experienced HIV-1 infected patients with limited or no treatment options.
    Medical condition: HIV-1 infected patient
    Disease: Version SOC Term Classification Code Term Level
    7.1 10020161 4
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-003955-40 Sponsor Protocol Number: TMC114FD1HTX1004 Start Date*: 2022-05-10
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Single-dose, Open-label, Randomized, Crossover Pivotal Bioequivalence Study in Healthy Participants to Assess the Bioequivalence of Darunavir 600 mg in the Presence of Cobicistat 90 mg When Admin...
    Medical condition: Human Immunodeficiency Virus-1 (Healthy participants)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10020443 Human immunodeficiency virus syndrome LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (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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