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Clinical trials for Faldaprevir

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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    4 result(s) found for: Faldaprevir. Displaying page 1 of 1.
    EudraCT Number: 2012-003534-17 Sponsor Protocol Number: 1241.30 Start Date*: 2013-04-05
    Sponsor Name:Boehringer Ingelheim España S.A
    Full Title: A phase II randomised, double-blind and placebo-controlled study of BI 207127 in combination with faldaprevir and ribavirin in patients with moderate hepatic impairment (Child-Pugh B) with genotype...
    Medical condition: Chronic Hepatitis C Infection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) GB (Prematurely Ended) IT (Prematurely Ended) IE (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2012-003535-27 Sponsor Protocol Number: 1241.36 Start Date*: 2012-10-17
    Sponsor Name:SCS Boehringer Ingelheim Comm.V
    Full Title: A phase III randomised, partially double-blind and placebo-controlled study of BI 207127 in combination with faldaprevir and ribavirin for chronic genotype 1 hepatitis C infection in an extended p...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    17.0 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) PT (Completed) GB (Completed) ES (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-003533-41 Sponsor Protocol Number: 1241.20 Start Date*: 2012-12-04
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: A Phase III, Randomised, Partially Double-Blind and Placebo-Controlled Study of BI 207127 in Combination with Faldaprevir and Ribavirin in Treatment-Naïve Patients with Chronic Genotype 1 HCV Infec...
    Medical condition: Chronic infection with HCV - genotype 1
    Disease: Version SOC Term Classification Code Term Level
    17.0 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PT (Completed) GB (Completed) ES (Completed) IE (Completed) IT (Completed) NL (Completed) HU (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2012-004544-30 Sponsor Protocol Number: 1241.37 Start Date*: 2013-04-03
    Sponsor Name:SCS Boehringer Ingelheim Comm.V
    Full Title: A phase III, randomised, open label, active-controlled study of an interferon-free regimen of BI 207127 in combination with Faldaprevir and Ribavirin compared to Telaprevir in combination with pe...
    Medical condition: Hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    16.0 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) SE (Prematurely Ended) NO (Completed) IT (Prematurely Ended) GB (Prematurely Ended) ES (Prematurely Ended) DE (Completed) DK (Prematurely Ended) FR (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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