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Clinical trials for Alisporivir

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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    10 result(s) found for: Alisporivir. Displaying page 1 of 1.
    EudraCT Number: 2011-006132-24 Sponsor Protocol Number: CDEB025A2313 Start Date*: 2012-05-18
    Sponsor Name:Novartis Farmaceutica, S.A.
    Full Title: A multi-centre 3-year follow-up study to assess the viral activity in patients who failed to achieve sustained virologic response in Novartis-sponsored alisporivir studies for chronic hepatitis C p...
    Medical condition: Chronic hepatitis C patients who failed to achieve sustained virologic response (SVR24) on alisporivir or direct-acting antivirals (DAA) in previous Novartis-sponsored studies.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) HU (Prematurely Ended) GB (Completed) PL (Prematurely Ended) IT (Prematurely Ended) DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-006131-38 Sponsor Protocol Number: CDEB025A2312 Start Date*: 2012-05-18
    Sponsor Name:Novartis Farmaceutica, S.A.
    Full Title: A multi-centre 3-year follow-up study to assess the durability of sustained virologic response in alisporivir treated chronic hepatitis C patients
    Medical condition: Chronic hepatitis C in patients who achieved sustained virologic response (SVR24) on alisporivir in a Novartis-sponsored chronic Hepatitis C study.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) HU (Completed) GB (Completed) PL (Completed) IT (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-002295-13 Sponsor Protocol Number: APHP200552 Start Date*: 2020-10-15
    Sponsor Name:Assistance Publique - Hôpitaux Paris
    Full Title: Evaluation of the efficacy, safety and tolerability of alisporivir for the treatment of hospitalised patients with infections due to SARS-CoV-2 (COVID-19). A randomised, open-label, proof of conc...
    Medical condition: The study population will consist of adults (18-80 years old) hospitalised for ≤48 hours prior to randomisation with a diagnosis of COVID-19 based on symptoms onset and SARS-CoV-2 RT-PCR test posit...
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10051905 Coronavirus infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-003559-21 Sponsor Protocol Number: CDEB025A2212 Start Date*: 2012-02-28
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Retrospective Pharmacogenetic Analysis of Hepatitis C Patients treated with Alisporivir (DEB025) Alone or in Combination with Peg-IFN2a and/or Ribavirin
    Medical condition: Hepatitis C and how biomarkers affect the response to treatment of the disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) IT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2013-003751-38 Sponsor Protocol Number: CDEB025A2233 Start Date*: 2014-03-27
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multicenter, open-label, randomized, 2-arm, phase II trial of pharmacodynamics, pharmacokinetics and safety of two dose regimens of DEB025/alisporivir in combination with ribavirin therapy in c...
    Medical condition: Chronic hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    18.0 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2012-004185-17 Sponsor Protocol Number: CDEB025A2222 Start Date*: 2013-08-15
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multicenter, open-label, randomized, 3-arm, phase II profiling trial of pharmacokinetics, pharmacodynamics and safety of DEB025/Alisporivir in combination with ribavirin therapy in chronic hepa...
    Medical condition: Chronic hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DE (Completed) GB (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-004653-31 Sponsor Protocol Number: CDEB025A2306 Start Date*: 2012-02-22
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multicenter, single-arm trial evaluating the safety and efficacy of DEB025/Alisporivir in combination with pegylated interferon-α2a and ribavirin (peg-IFNα2a/RBV) in protease inhibitor treatment ...
    Medical condition: Chronic hepatitis C genotype 1 protease inhibitor (PI) treatment failure
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) ES (Prematurely Ended) GB (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-020034-26 Sponsor Protocol Number: CDEB025A2211 Start Date*: 2010-11-18
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multicenter, randomized, open label, parallel-group phase IIB study on the efficacy and safety of oral regimens of DEB025 alone or in combination with ribavirin versus Standard of Care (peg-IFN a...
    Medical condition: Chronic Hepatitis C Genotype 2 and 3 patients
    Disease: Version SOC Term Classification Code Term Level
    12.1 10008912 Chronic hepatitis C LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed) GB (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-020033-14 Sponsor Protocol Number: CDEB025A2210 Start Date*: 2010-09-03
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multicentre, randomized, double-blind, placebocontrolled, parallel-group phase II study on efficacy and safety of DEB025 combined with peg-IFN alfa-2a and ribavirin in chronic hepatitis C genotyp...
    Medical condition: Chronic Hepatitis C Genotype 1 patients
    Disease: Version SOC Term Classification Code Term Level
    15.0 10021881 - Infections and infestations 10008912 Chronic hepatitis C LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) DE (Completed) FR (Completed) ES (Completed) BE (Completed) IT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2010-022867-37 Sponsor Protocol Number: CDEB025A2301 Start Date*: 2011-05-18
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized, double-blind, placebo-controlled trial of the efficacy and safety of DEB025/Alisporivir in combination with peg-IFN alfa2a and ribavirin in hepatitis C genotype 1 treatment-naïve pati...
    Medical condition: Chronic Hepatitis C genotype 1 treatment-naïve patients
    Disease: Version SOC Term Classification Code Term Level
    15.0 10021881 - Infections and infestations 10008912 Chronic hepatitis C LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) DE (Completed) BE (Completed) GB (Completed) PL (Completed) IT (Completed) ES (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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