1220.5 Protease Inhibitor (BI 201335 NA) study in hepatitis C patients

• Research type

  Research Study

• Full title

  1220.5 Antiviral effect, safety and pharmacokinetics of once daily BI 201335 NA in hepatitis C virus genotype 1 infected treatment-naïve patients for 24 weeks as combination therapy with pegylated interferon-a 2a and ribavirin (double-blinded, randomised, placebo-controlled, Phase II)

• IRAS ID

  5173

• Contact name

  Graham Foster

• Sponsor organisation

  Boehringer Ingelheim

• Eudract number

  2008-003538-11

• Clinicaltrials.gov Identifier

  00774397

• Research summary

  This is a phase II study to evaluate the safety, effectiveness and pharmacokinetics of an anti-viral medication in combination with pegylated interferon a and ribavirin (current standard of care treatment) in the treatment of hepatitis C virus genotype 1 infected, treatment-naÇîve and treatment-experienced patients. Patients will be treated with BI 201335 in combination with Pegylated Interferon-alpha 2a and Ribavirin for 24 weeks and followed up for 72 weeks after treatment completion.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  08/H0703/118

• Date of REC Opinion

  8 Jan 2009

• REC opinion

  Further Information Favourable Opinion