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A phase Ib, multicentre, randomized, double-blind, cohort, placebo-controlled, multiple ascending-dose study to evaluate the safety, tolerability and pharmacokinetics of PSI 938 (GS-0938), Sofosbuvir (GS-7977, PSI 7977) and their combination in treatment-naive patients with chronic hepatitis C genotype 1 infection.

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Trial Profile

A phase Ib, multicentre, randomized, double-blind, cohort, placebo-controlled, multiple ascending-dose study to evaluate the safety, tolerability and pharmacokinetics of PSI 938 (GS-0938), Sofosbuvir (GS-7977, PSI 7977) and their combination in treatment-naive patients with chronic hepatitis C genotype 1 infection.

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 05 Dec 2015

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At a glance

  • Drugs PSI 938 (Primary) ; Sofosbuvir (Primary)
  • Indications Hepatitis C
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics
  • Acronyms NUCLEAR

Most Recent Events

  • 28 Mar 2011 Results will be presented at EASL-2011 according to a Pharmasset media release.
  • 06 Jan 2011 Interim results for the PSI 938 300mg QD group presented in a Pharmasset media release
  • 06 Jan 2011 Patients now being enrolled in the second and third cohorts, and further data expected to be reported during the first quarter of 2011, according to a Pharmasset media release

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