Value through Innovation27 July 2016

Clinical Study Results

  • BILB 1941 - Hepatitis C, Chronic
    Clinical Study Number 1201.14
    Study Indication Hepatitis C, Chronic
    Product BILB 1941
    Generic Name BILB 1941
    Lab Code
    Clinical Phase Ib
    Study Title

    A multinational randomised, double-blind, placebo controlled study to evaluatethe antiviral pharmacodynamic effect, safety, and pharmacokinetics of escalatingdoses of BILB 1941 ZW oral solution administered Q8H for five days to patientswith chronic hepatitis C genotype 1 virus infection

    Study Document Trial synopsis 1201.14 english
  • Ciluprevir - Hepatitis C, Chronic
    Clinical Study Number 605.5
    Study Indication Hepatitis C, Chronic
    Product Ciluprevir
    Generic Name Ciluprevir
    Lab Code
    Clinical Phase IIa
    Study Title

    A randomised, double-blind, placebo controlled trial with 25 mg,200 mg and 500 mg BILN 2061 ZW given p.o.at two consecutive days bid to investigate the antiviral efficacy, pharmacokinetics, safety in patients with chronic hepatitis C virus infection

    Study Document Trial synopsis 605.5_CO english
  • Ciluprevir - Hepatitis C, Chronic
    Clinical Study Number 605.9
    Study Indication Hepatitis C, Chronic
    Product Ciluprevir
    Generic Name Ciluprevir
    Lab Code
    Clinical Phase IIa
    Study Title

    A randomised, double-blind, placebo controlled trial with 200 mg BILN2061 ZW given p.o. at two consecutive days bid to investigate the antiviral efficacy, pharmacokinetics, safety in patients with cirrhosis and chronic hepatitis C

    Study Document Trial synopsis 605.9_CO english
  • Deleobuvir - Hepatitis C, Chronic
    Clinical Study Number 1241.30
    Study Indication Hepatitis C, Chronic
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase IIb
    Study Title

    A phase IIb open label study of BI 207127 in combination with faldaprevir and ribavirin in patients with moderate hepatic impairment (Child-Pugh B) with genotype 1b chronic hepatitis C infection

    Study Document Trial synopsis 1241.30_DR english
  • Deleobuvir - Hepatitis C, Chronic
    Clinical Study Number 1241.21
    Study Indication Hepatitis C, Chronic
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase Ib/II
    Study 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 infection (randomized Phase Ib/II)

    Study Document Trial synopsis 1241.21_DR english
  • Deleobuvir - Hepatitis C, Chronic
    Clinical Study Number 1241.2
    Study Indication Hepatitis C, Chronic
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase Ib
    Study Title

    Safety, antiviral activity, and pharmacokinetics of multiple oral doses of BI 207127 NA administered q8H for 5 days as monotherapy, a randomised, double-blind, placebo controlled study

    Study Document Trial synopsis 1241.2_DS_DR english
  • Deleobuvir - Hepatitis C, Chronic
    Clinical Study Number 1241.20
    Study Indication Hepatitis C, Chronic
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase III
    Study Title

    A phase III, Randomized, Partially Double-Blind and Placebo-Controlled Study of BI 207127 in Combination with Faldaprevir and Ribavirin in Treatment-Naive Patients with Chronic Genotype 1 HCV Infection

    Study Document Trial synopsis 1241.20_DR english
  • Deleobuvir - Hepatitis C, Chronic
    Clinical Study Number 1241.25
    Study Indication Hepatitis C, Chronic
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase IIa
    Study Title

    An open-label, ascending dose, phase II study to evaluate tolerability, safety, antiviral activity, and pharmacokinetics of BI 207127 NA in combination with BI 201335 NA and ribavirin for 8 weeks in treatment-naive Japanese patients with genotype 1chronic hepatitis C virus infection

    Study Document Trial synopsis 1241.25_DR english
  • Deleobuvir - Hepatitis C, Chronic
    Clinical Study Number 1241.27
    Study Indication Hepatitis C, Chronic
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase Ib
    Study Title

    A multi-centre, open label, parallel group trial to evaluate the pharmacokinetic interactions between BI 207127 (600 mg t.i.d. or 600 mg b.i.d.) and BI 201335 (120 mg q.d.) given in combination with ribavirin for 24 weeks, and their combined effect on the pharmacokinetics of tenofovir, raltegravir, caffeine (the probe drug substrate for CYP1A2), tolbutamide (the probe drug substrate for CYP2C9) and midazolam (the probe drug substrate for CYP3A4) in treatment naive patients and prior treatment relapse or partial responder patients with genotype 1 chronic hepatitis C infection

    Study Document Trial synopsis 1241.27_DR english
  • Deleobuvir - Hepatitis C, Chronic
    Clinical Study Number 1241.36
    Study Indication Hepatitis C, Chronic
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase III
    Study 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 population of treatment naive patients that includes those ineligible to receive peginterferon

    Study Document Trial synopsis 1241.36 english
  • Deleobuvir - Hepatitis C, Chronic
    Clinical Study Number 1241.7
    Study Indication Hepatitis C, Chronic
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase Ib
    Study Title

    Safety, antiviral activity, and pharmacokinetics of BI 207127 NA administered in combination with Peg-IFN and ribavirin in chronic HCV-infected patients for 4 weeks, a randomised, double-blind, placebo controlled study

    Study Document Trial synopsis 1241.7_DS_DR english
  • Faldaprevir - Hepatitis C, Chronic
    Clinical Study Number 1220.19
    Study Indication Hepatitis C, Chronic
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase III
    Study Title

    Safety and Efficacy of 120 mg and 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-infected patients. A multinational, randomised, parallel group, open-label trial.

    Study Document Trial synopsis 1220.19_DR english
  • Faldaprevir - Hepatitis C, Chronic
    Clinical Study Number 1220.2
    Study Indication Hepatitis C, Chronic
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase Ib
    Study Title

    Safety, antiviral activity, and pharmacokinetics of multiple rising oral doses of BI 201335 NA in treatment-naive patients with chronic hepatitis C infection for14 days monotherapy followed by combination with Pegylated Interferon and Ribavirin for an additional 14 days (double-blind, placebo controlled); and in treatment-experienced patients with chronic hepatitis C infection for 28 days as combination therapy with Pegylated Interferon and Ribavirin (open-label)

    Study Document Trial synopsis 1220.2_PE_DS_DR english Trial synopsis 1220.2_DS_DR english
  • Faldaprevir - Hepatitis C, Chronic
    Clinical Study Number 1220.5
    Study Indication Hepatitis C, Chronic
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase II
    Study Title

    Antiviral effect, safety, and pharmacokinetics of BI 201335 NA in hepatitis C virus genotype 1 infected treatment-naive and treatment-experienced patients for 24 weeks as combination therapy with pegylated interferon ?-2a and ribavirin (double blinded, randomised, placebo controlled, Phase II)

    Study Document Trial synopsis 1220.5_DS_DR english
  • Faldaprevir - Hepatitis C, Chronic
    Clinical Study Number 1220.7
    Study Indication Hepatitis C, Chronic
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase III
    Study 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-a (PegIFNa) and ribavirin (RBV) in patients with genotype 1 chronic hepatitis C infection who failed a prior PegIFN/RBV treatment

    Study Document Trial synopsis 1220.7_DR english
  • Faldaprevir - Hepatitis C, Chronic
    Clinical Study Number 1220.47
    Study Indication Hepatitis C, Chronic
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase III
    Study Title

    A phase III, randomised, double-blind and placebo-controlled study of once daily BI 201335 120 mg for 24 weeks and BI 201335 240 mg for 12 weeks in combination with pegylated interferon-? and ribavirin in treatment-naive patients with genotype 1 chronic hepatitis C infection

    Study Document Trial synopsis 1220.47_DR english
  • Faldaprevir - Hepatitis C, Chronic
    Clinical Study Number 1220.48
    Study Indication Hepatitis C, Chronic
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase III
    Study Title

    A phase III, open-label study of once daily BI 201335 240 mg for 24 weeks in combination with pegylated interferon-? (PegIFN) and ribavirin (RBV) in patients with genotype 1 chronic hepatitis C infection who failed a priorPegIFN / RBV treatment

    Study Document Trial synopsis 1220.48_DR english
  • Faldaprevir - Hepatitis C, Chronic
    Clinical Study Number 1220.54
    Study Indication Hepatitis C, Chronic
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase III
    Study Title

    Safety, efficacy and pharmacokinetics of BI 201335 NA in patient with genotype 1 chronic hepatitis C virus infection in combination with pegylated interferon alfa-2b and ribavirin - Cohort 1 for treatment-naive patients: randomised, double-blind part of BI 201335 NA for 12 or 24 weeks - Cohort 2 for treatment-experienced patients: open-label part of BI 201335 NA for 24 weeks

    Study Document Trial synopsis 1220.54_DR english
  • Deleobuvir - Hepatitis C, Chronic
    Clinical Study Number 1241.37
    Study Indication Hepatitis C, Chronic
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase III
    Study 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 pegylated interferon-a and ribavirin in treatment-naive patients with chronic genotype 1b Hepatitis C Virus infection

    Study Document Trial statement 1241.37 english

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