A phase 1, randomized, observer-blind, dose-escalating study in adult end-stage renal failure patients to explore the safety, tolerability, pharmacokinetics and immune response to recombinant hepatitis B virus surface antigen (rHBsAg) co-administered with Dynavax immunostimulatory phosphorothioate oligodeoxyribonucleotide (1018 ISS).

Trial Profile

A phase 1, randomized, observer-blind, dose-escalating study in adult end-stage renal failure patients to explore the safety, tolerability, pharmacokinetics and immune response to recombinant hepatitis B virus surface antigen (rHBsAg) co-administered with Dynavax immunostimulatory phosphorothioate oligodeoxyribonucleotide (1018 ISS).

Completed
Phase of Trial: Phase I

Latest Information Update: 06 Mar 2017

At a glance

  • Drugs V 270 (Primary) ; Hepatitis B vaccine recombinant
  • Indications Hepatitis B
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics
  • Sponsors Dynavax Technologies
  • Most Recent Events

    • 20 Jul 2010 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 28 Jul 2009 Actual number of patients (42) added as reported by ClinicalTrials.gov
    • 21 Feb 2007 New trial record.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top