Value through Innovation27 July 2016

Clinical Study Results

  • APTIVUS ® - Hepatitis C
    Clinical Study Number 1182.59
    Study Indication Hepatitis C
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    Open label, study to determine the pharmacokinetic interactions of steady state tipranavir/ritonavir (500/200 mg) and steady state ribavirin and pegylated Interferon alfa 2a in HIV negative, HCV infected subjects with mild hepatic impairment and the pharmacokinetic properties of tipranavir/ritonavir in HIV negative, HCV, HBV, hepatitis delta infected subjects or alcoholic cirrhosis subjects with moderate hepatic impairment

    Study Document Trial synopsis 1182.59 english
  • Faldaprevir - Hepatitis C
    Clinical Study Number 1220.14
    Study Indication Hepatitis C
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase IIa
    Study Title

    Safety, pharmacokinetics and antiviral effect of BI 201335 NA in HCV-1 infected patients treated for 28 days for treatment naive and experienced patients treated in combination with Peg Interferon ?-2a and ribavirin

    Study Document Trial synopsis 1220.14_DS_DR english
  • Faldaprevir - Hepatitis C
    Clinical Study Number 1220.15
    Study Indication Hepatitis C
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    An open label single dose phase I trial of 120 mg and 240 mg BI 201335 soft gel capsules to study pharmacokinetic properties and safety in patients with compensated liver cirrhosis in historical comparison with 1220.2

    Study Document Trial synopsis 1220.15_DS_DR english
  • Faldaprevir - Hepatitis C
    Clinical Study Number 1220.30
    Study Indication Hepatitis C
    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 faldaprevir 120 mg for 12 or 24 weeks or faldaprevir 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 1220.30_DR english
  • Faldaprevir - Hepatitis C
    Clinical Study Number 1220.40
    Study Indication Hepatitis C
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase II
    Study Title

    Antiviral effect and safety of once daily BI 201335 NA in hepatitis C virus genotype 1 infected treatment-naive patients for 12 or 24 weeks as combination therapy with pegylated interferon-? 2a and ribavirin (open-label, randomised, Phase II)

    Study Document Trial synopsis 1220.40_DS_DR english

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