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Clinical trials for Product quality issues

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   44412   clinical trials with a EudraCT protocol, of which   7421   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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    12 result(s) found for: Product quality issues. Displaying page 1 of 1.
    EudraCT Number: 2016-004129-18 Sponsor Protocol Number: AK581 Start Date*: 2017-03-17
    Sponsor Name:Akari Therapeutics Plc
    Full Title: CONSERVE: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study
    Medical condition: Paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10005329 - Blood and lymphatic system disorders 10018932 Haemolytic uraemic syndrome PT
    21.1 10038359 - Renal and urinary disorders 10034042 Paroxysmal nocturnal haemoglobinuria PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) PL (Prematurely Ended) NL (Prematurely Ended) LT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-000435-13 Sponsor Protocol Number: JWGKDVAAP0117 Start Date*: 2017-11-13
    Sponsor Name:University Hospital Frankfurt for its Dermatology Department, Clinical Research
    Full Title: Exploratory study to evaluate changes in inflammatory pattern and analysis for serum biomarkers in patients with active, moderate-to-severe hidradenitis suppurativa after 2-week and 6-week treatmen...
    Medical condition: Hidradenitis suppurativa is defined as a chronic inflammatory disease of the intertriginous area, including the axilla, groin and anogenital or submammary regions. The condition is characterized by...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-003256-32 Sponsor Protocol Number: MO42245 Start Date*: 2021-04-14
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: AN INTERVENTIONAL OPEN-LABEL MULTICENTER PHASE IV STUDY TO EVALUATE THE IMPACT OF EMICIZUMAB ON HEALTH-RELATED QUALITY OF LIFE, PHYSICAL ACTIVITY, AND JOINT HEALTH IN PATIENTS WITH SEVERE HEMOPHILI...
    Medical condition: Severe hemophilia A without factor VIII inhibitors
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10053753 Hemophilia A without inhibitors LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: SE (Completed) NO (Completed) FI (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2017-002204-27 Sponsor Protocol Number: GS030_CLIN_001 Start Date*: 2017-12-22
    Sponsor Name:GENSIGHT-BIOLOGICS
    Full Title: A Phase 1/2a, Open-Label, Non-Randomized, Dose-Escalation Study to Evaluate the Safety and Tolerability of GS030 in Subjects with Retinitis Pigmentosa
    Medical condition: Retinitis Pigmentosa
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-003879-42 Sponsor Protocol Number: 2021/ABM/03/00006 Start Date*: 2023-04-12
    Sponsor Name:Medical Univeristy of Bialystok
    Full Title: A randomized, controlled, double-blind clinical trial evaluating the effect of METformin treatment on endometrial function in women diagnosed with Idiopathic Infertility
    Medical condition: Potential causes of idiopathic infertility include in particular: abnormal function of the endometrium, including implantation disorders and immunological abnormalities, genetic abnormalities and t...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10016471 Fertility and fertilisation interventions female HLT
    20.0 10038604 - Reproductive system and breast disorders 10021928 Infertility female PT
    Population Age: Adults Gender: Female
    Trial protocol: PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-000694-39 Sponsor Protocol Number: SPL7013-018 Start Date*: 2014-10-22
    Sponsor Name:Starpharma Pty Ltd
    Full Title: A phase 3, double-blind, multicentre, randomised, placebo-controlled study to determine the efficacy and safety of SPL7013 Gel (VivaGel®) to prevent the recurrence of bacterial vaginosis
    Medical condition: recurrent bacterial vaginosis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10004055 Bacterial vaginosis PT
    Population Age: Adults Gender: Female
    Trial protocol: CZ (Completed) GB (Completed) HU (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2013-001449-15 Sponsor Protocol Number: R668-AD-1225 Start Date*: 2013-12-05
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: AN OPEN-LABEL STUDY OF DUPILUMAB IN PATIENTS WITH ATOPIC DERMATITIS WHO PARTICIPATED IN PREVIOUS DUPILUMAB CLINICAL TRIALS
    Medical condition: Atopic dermatits
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000018018 10003639 Atopic dermatitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) HU (Completed) DE (Completed) PL (Completed) SE (Completed) LT (Completed) EE (Completed) DK (Completed) FI (Completed) ES (Completed) IT (Completed) NL (Completed) AT (Completed) BE (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2015-003471-30 Sponsor Protocol Number: D-FR-52120-222 Start Date*: 2016-09-26
    Sponsor Name:Ipsen Innovation
    Full Title: A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT...
    Medical condition: Urinary incontinence (UI) caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10038359 - Renal and urinary disorders 10046543 Urinary incontinence PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: RO (Completed) PT (Completed) CZ (Completed) IT (Completed) NL (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2017-003281-27 Sponsor Protocol Number: BCX7353-204 Start Date*: 2017-12-27
    Sponsor Name:BioCryst Pharmaceuticals Inc
    Full Title: An Open-Label study to Evaluate the Long-Term Safety of Daily Oral BCX7353 in subjects with Type I and II Hereditary Angioedema
    Medical condition: Hereditary Angioedema
    Disease: Version SOC Term Classification Code Term Level
    23.1 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) HU (Completed) DK (Completed) AT (Completed) ES (Completed) SK (Completed) PL (Completed) BE (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-000507-44 Sponsor Protocol Number: D-FR-52120-223 Start Date*: 2016-06-29
    Sponsor Name:Ipsen Innovation
    Full Title: A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT...
    Medical condition: Urinary incontinence caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10038359 - Renal and urinary disorders 10046543 Urinary incontinence PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) ES (Completed) FR (Completed) LT (Completed)
    Trial results: View results
    EudraCT Number: 2020-001056-17 Sponsor Protocol Number: 3606 Start Date*: 2020-08-14
    Sponsor Name:Kings's College London [...]
    1. Kings's College London
    2. South London and Maudsley NHS Foundation Trust
    Full Title: A randomised feasibility trial investigating Sativex® for the treatment of the Agitation & Aggression (A/A) in Alzheimer’s Dementia.
    Medical condition: Clinically significant agitation in Alzheimer's Diseases
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10001499 Agitation mental LLT
    20.0 10037175 - Psychiatric disorders 10001497 Agitation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2017-001982-26 Sponsor Protocol Number: OZM-063 Start Date*: 2018-04-26
    Sponsor Name:The Hospital for Sick Children
    Full Title: A phase II, open-labeled, multi-center, randomized controlled trial of Vinblastine +/- Bevacizumab for the treatment of chemotherapy-naïve children with unresectable or progressive low grade glioma...
    Medical condition: Unresectable or progressive low grade glioma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10018338 Glioma PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    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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