Safety, Antiviral Activity, and Pharmacokinetics of Multiple Rising Oral Doses of BI 201335 NA in Treatment-naïve Patients With Chronic Hepatitis C Infection for 14 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)

Trial Profile

Safety, Antiviral Activity, and Pharmacokinetics of Multiple Rising Oral Doses of BI 201335 NA in Treatment-naïve Patients With Chronic Hepatitis C Infection for 14 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)

Completed
Phase of Trial: Phase I

Latest Information Update: 06 Oct 2015

At a glance

  • Drugs Faldaprevir (Primary) ; Peginterferon alfa-2a; Ribavirin
  • Indications Hepatitis C
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Boehringer Ingelheim
  • Most Recent Events

    • 14 Feb 2011 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 18 Oct 2010 Planned end date changed from 1 Oct 2010 to 1 Jan 2011 as reported by ClinicalTrials.gov.
    • 30 Oct 2009 Results were reported at the 60th Annual Meeting of the American Association for the Study of Liver Diseases.
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