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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)

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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)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 09 Nov 2021

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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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