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Clinical trials for BI 201335

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   44336   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 ).  
     
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    10 result(s) found for: BI 201335. Displaying page 1 of 1.
    EudraCT Number: 2009-018197-66 Sponsor Protocol Number: 1241.21 Start Date*: 2010-04-29
    Sponsor Name:Unilfarma, Lda.
    Full Title: Safety, antiviral effect and pharmacokinetics of BI 207127 in combination with BI 201335 and with or without ribavirin for 4, 16, 24, 28 or 40 weeks in patients with chronic HCV genotype 1 infectio...
    Medical condition: chronic hepatitis C infection of genotype 1
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004848 10019751 Hepatitis C virus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Completed) FR (Completed) DE (Completed) AT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2010-021716-42 Sponsor Protocol Number: 1220.30 Start Date*: 2011-03-11
    Sponsor Name:Boehringer Ingelheim International GmbH
    Full Title: A phase III, randomised, double-blind and placebo-controlled study of once daily BI 201335 120 mg for 12 or 24 weeks or BI 201335 240 mg for 12 weeks in combination with pegylated interferon-α and ...
    Medical condition: genotype 1 chronic hepatitis C infection
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10019744 Hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Completed) BE (Completed) GB (Completed) DE (Completed) ES (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2010-021734-59 Sponsor Protocol Number: 1220.19 Start Date*: 2011-08-11
    Sponsor Name:Boehringer Ingelheim Limited
    Full Title: Safety and Efficacy of 240 mg BI 201335 once daily in combination with pegylated interferon alpha 2a and ribavirin for treatment of chronic Hepatitis C (HCV) genotype 1 infection in HIV/HCV-co-in...
    Medical condition: Chronic hepatitis C infection genotype 1 in patients coinfected with HIV-1
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10019744 Hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) DE (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-021715-17 Sponsor Protocol Number: 1220.7 Start Date*: 2011-07-12
    Sponsor Name:Boehringer Ingelheim Limited
    Full Title: A phase III, randomised, double-blind and placebo controlled study of once daily BI 201335, 240 mg for 12 or 24 weeks in combination with pegylated interferon-α and ribavirin in patients with genot...
    Medical condition: Chronic hepatitis C infection genotype 1
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10019744 Hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) PT (Completed) BE (Completed) DE (Completed) AT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2008-003538-11 Sponsor Protocol Number: 1220.5 Start Date*: 2008-10-01
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: Antiviral effect, safety and pharmacokinetics of BI 201335 NA in hepatitis C virus genotype 1 infected treatment-naïve and treatment-experienced patients for 24 weeks as combination therapy with pe...
    Medical condition: chronic hepatitis C infection of genotype 1
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10047457 Viral hepatitis C LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) FR (Completed) NL (Completed) PT (Completed) GB (Completed) AT (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2009-012579-90 Sponsor Protocol Number: 1220.40 Start Date*: 2009-08-04
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: Antiviral effect and safety of once daily BI 201335 NA in hepatitis C virus genotype 1 infected treatment-naïve patients for 12 or 24 weeks as combination therapy with pegylated interferon-α 2a and...
    Medical condition: chronic hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    9.1 10002724 Anti-HCV positive LLT
    9.1 10019183 HCV LLT
    9.1 10019752 Hepatitis C virus (HCV) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2011-000141-20 Sponsor Protocol Number: 1220.48 Start Date*: 2011-07-12
    Sponsor Name:Boehringer Ingelheim Limited
    Full Title: A phase III, open-label study of once daily BI 201335 240 mg for 24 weeks in combination with pegylated interferon-α (PegIFN) and ribavirin (RBV) in patients with genotype 1 chronic hepatitis C inf...
    Medical condition: Hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10019744 Hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) PT (Completed) DE (Completed) AT (Completed) BE (Completed) ES (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: 2012-003534-17 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
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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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