A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study on Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders to Previous Peg-IFN Alfa-2 Plus Ribavirin Treatment

Trial Profile

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study on Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders to Previous Peg-IFN Alfa-2 Plus Ribavirin Treatment

Completed
Phase of Trial: Phase II

Latest Information Update: 01 Sep 2016

At a glance

  • Drugs Alisporivir (Primary) ; Peginterferon alfa-2a; Ribavirin
  • Indications Hepatitis C
  • Focus Therapeutic Use
  • Acronyms FUNDAMENTAL
  • Sponsors Debiopharm; Novartis Pharma A.G.
  • Most Recent Events

    • 01 May 2013 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
    • 13 Oct 2012 Planned number of patients changed from 344 to 461 as reported by European Clinical Trials Database.
    • 01 Oct 2012 Interim results presented at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases
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