A Multicenter, Randomized, Double-blind, Placebo-controlled, Multi-dose Study to Determine the Depth of Hepatitis B Surface Antigen (HBsAg) Reduction Following Intravenous ARC-520 in Combination with Entecavir or Tenofovir in Patients with HBeAg Positive, Chronic Hepatitis B Virus (HBV) Infection
Phase of Trial: Phase II
Latest Information Update: 02 Aug 2017
At a glance
- Drugs ARC 520 (Primary) ; Entecavir; Tenofovir disoproxil fumarate
- Indications Hepatitis B
- Focus Therapeutic Use
- Sponsors Arrowhead Pharmaceuticals
- 29 Nov 2016 Arrowhead Pharmaceuticals discontinued the development of ARC-520 based upon the discussion with the regulatory agencies regarding the substantial delays in all clinical programs that utilize EX1 and secondly, company has made substantial advances in RNA chemistry and targeting resulting in large potency gains for subQ administered and extra-hepatic RNAi-based development programs. Patients recruitment has been halted and dosing discontinued.
- 29 Nov 2016 Status changed from recruiting to discontinued, as per an Arrowhead Pharmaceuticals media release.
- 27 Apr 2016 Planned End Date changed from 1 Dec 2016 to 1 Mar 2017.