A Phase 3 trial of TXL in treatment-naïve patients with chronic hepatitis B (both HBeAg and HeAg)

Trial Profile

A Phase 3 trial of TXL in treatment-naïve patients with chronic hepatitis B (both HBeAg and HeAg)

Planning
Phase of Trial: Phase III

Latest Information Update: 16 Feb 2018

At a glance

  • Drugs Tenofovir exalidex (Primary)
  • Indications Hepatitis B
  • Focus Registrational; Therapeutic Use
  • Sponsors ContraVir Pharmaceuticals
  • Most Recent Events

    • 16 Feb 2018 New trial record
    • 12 Feb 2018 According to a ContraVir Pharmaceuticals media release, the company the U.S. Food and Drug Administration (FDA) has agreed to allow the company to utilize the 505(b)(2) Regulatory Pathway to streamline the development and registration of TXL for the treatment of Chronic Hepatitis B. US FDA also agreed on the major elements of design of this trial including duration of treatment, clinical endpoints, comparator and number of patients needed for NDA submission.
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