A Multi-center, Placebo-Controlled, Dose Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Pegylated Interferon and Ribavirin in Treatment-Naïve Patients With Chronic HCV Infection Genotype 1, and an Open Label Assessment of PSI-7977 in Patients With HCV Genotypes 2 or 3.

Trial Profile

A Multi-center, Placebo-Controlled, Dose Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Pegylated Interferon and Ribavirin in Treatment-Naïve Patients With Chronic HCV Infection Genotype 1, and an Open Label Assessment of PSI-7977 in Patients With HCV Genotypes 2 or 3.

Completed
Phase of Trial: Phase II

Latest Information Update: 28 Sep 2014

At a glance

  • Drugs Sofosbuvir (Primary) ; Peginterferon alfa-2a; Ribavirin
  • Indications Hepatitis C
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms PROTON
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 30 May 2012 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 19 Apr 2012 Results will be presented at the 47th Annual meeting of the European Asoociation for the Study of the Liver (EASL-2012).
    • 13 Feb 2012 Company (Gilead Sciences) added as trial sponsor and additional lead trial centre and investigator identified as reported by ClinicalTrials.gov.
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