A Phase III, Randomized, 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 Alpha and Ribavirin in Treatment Naive Patients With Genotype 1 Chronic Hepatitis C Infection.

Trial Profile

A Phase III, Randomized, 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 Alpha and Ribavirin in Treatment Naive Patients With Genotype 1 Chronic Hepatitis C Infection.

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Sep 2016

At a glance

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

    • 17 Sep 2015 Endpoints has been changed and timeframe of primary end point has been changed from 12 weeks to 12 weeks post treatment, up to 60 weeks. Number of arms has changed from 3 to 4 as reported by ClinicalTrials.gov record.
    • 16 Apr 2014 According to ClinicalTrials.gov record, status changed from active, no longer recruiting to completed.
    • 13 Apr 2014 Pooled pharmacokinetic-response analysis presented at the 49th Annual Meeting of the European Association for the Study of the Liver.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top