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Clinical trials for Helix

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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    8 result(s) found for: Helix. Displaying page 1 of 1.
    EudraCT Number: 2009-010078-39 Sponsor Protocol Number: HeLIX Start Date*: 2009-06-03
    Sponsor Name:Academic Medical Center
    Full Title: The effect of helium on the immune system ex vivo
    Medical condition: Healthy volunteers, Effects of helium on the immune system ex vivo
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-003699-60 Sponsor Protocol Number: KIBB01 Start Date*: 2018-09-28
    Sponsor Name:Karolinska Institutet
    Full Title: An exploratory, open label, multiple dose, multicentre phase I/II trial evaluating safety and efficacy of postnatal or prenatal and postnatal intravenous administration of allogeneic expanded fetal...
    Medical condition: Treatment of Osteogenesis Imperfecta (OI) type III and severe type IV.
    Disease:
    Population Age: In utero, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: SE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-003015-34 Sponsor Protocol Number: LDOS003 Start Date*: 2018-04-12
    Sponsor Name:Helix BioPharma Corp
    Full Title: A Phase II Open-Label, Randomized Study of Immunoconjugate L-DOS47 in Combination with Vinorelbine/Cisplatin Versus Vinorelbine/Cisplatin Alone in Patients with Lung Adenocarcinoma
    Medical condition: Lung adenocarcinoma chemotherapy naive or recurrent for which vinorelbine/cisplatin would be appropriate therapy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025031 Lung adenocarcinoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Prematurely Ended) HU (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-000162-40 Sponsor Protocol Number: IFN 001 Start Date*: 2005-09-06
    Sponsor Name:Helix Product Development (Ireland) Limited
    Full Title: Treatment of genital warts with Interferon alpha-2b Cream: a randomized, double blind, placebo-controlled study
    Medical condition: Condylomata acuminata (genital warts)
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: SE (Completed) DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-020729-42 Sponsor Protocol Number: LDOS002 Start Date*: Information not available in EudraCT
    Sponsor Name:Helix BioPharma Corp
    Full Title: A Phase I/II Open-Label, Non-Randomized Dose Escalation Study of Immunoconjugate L-DOS47 as a Monotherapy in Non-Squamous Non-Small Cell Lung Cancer Patients
    Medical condition: Inoperable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: View results
    EudraCT Number: 2008-006208-52 Sponsor Protocol Number: IFN005 Start Date*: 2009-03-09
    Sponsor Name:Helix BioPharma Cooperation
    Full Title: Mono-centre, open-label study to investigate the multi-dose pharmacokinetics, efficacy and safety of Interferon alpha-2b Cream in women with a history of cytological diagnosed Pap IIID, with a con...
    Medical condition: cervical dysplasia (CIN I or CIN II; Pap IIID in the history, confirmed HPV+ status)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10008263 Cervical dysplasia LLT
    Population Age: Adults Gender: Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-016778-34 Sponsor Protocol Number: TH09001 Start Date*: 2010-01-27
    Sponsor Name:THERABEL LUCIEN PHARMA
    Full Title: Evaluation de la non-infériorité de l’efficacité d’Helicidine® versus Sirop à base de dextromethorphane sur la toux sèche des patients pris en charge en médecine générale.
    Medical condition: Patients volontaires présentant un épisode de toux sèche et venant consulter en médecine générale.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10013773 Dry cough LLT
    12.1 10011224 Cough LLT
    12.1 10011233 Coughing and associated symptoms HLT
    12.1 10038716 Respiratory disorders NEC HLGT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-003903-79 Sponsor Protocol Number: SYL1001_IV Start Date*: 2017-07-24
    Sponsor Name:Sylentis SAU - PharmaMar Group
    Full Title: A double-masked study of SYL1001 in patients with moderate to severe dry eye disease (DED)
    Medical condition: Moderate to severe dry eye disease (DED)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10015919 - Eye disorders 10013774 Dry eye PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) PT (Completed) EE (Completed) SK (Completed) IT (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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