QUANTUM: An International, Multi-center, Blinded, Randomized Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Administration of Regimens Containing PSI-352938, PSI-7977, and Ribavirin in Patients With Chronic Hepatitis C Virus (HCV) Infection

Trial Profile

QUANTUM: An International, Multi-center, Blinded, Randomized Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Administration of Regimens Containing PSI-352938, PSI-7977, and Ribavirin in Patients With Chronic Hepatitis C Virus (HCV) Infection

Completed
Phase of Trial: Phase II

Latest Information Update: 02 Feb 2016

At a glance

  • Drugs PSI 938 (Primary) ; Sofosbuvir (Primary) ; Ribavirin
  • Indications Hepatitis C
  • Focus Therapeutic Use
  • Acronyms QUANTUM
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 07 Jan 2014 As per ClinicalTrials.gov record timeframe of primary endpoint is changed from week 24 to 12; PSI-938, PSI-938+sofosbuvir, PSI-938+sofosbuvir+ribavirin 12 weeks arm group is removed and Re-treatment: sofosbuvir+ribavirin (24 weeks) arm group added.
    • 01 May 2013 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 07 Jun 2012 Planned end date changed from 1 Aug 2013 to 1 Sep 2013 as reported by ClinicalTrials.gov.
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