Trial Search Results

Hepatitis B Virus (HBV) Viral Suppression by Entecavir in Adefovir Partial Responders

We propose a largely retrospective study with short-term prospective follow-up in a subgroup of patients who have not yet been treated with 48 weeks of entecavir following partial response to adefovir. The aim of the study is to describe sequential virologic response to adefovir and entecavir.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Pacific Health Foundation

Collaborator: Bristol-Myers Squibb

Stanford Investigator(s):

Intervention(s):

  • Drug: Entecavir

Eligibility


KEY INCLUSION CRITERIA:

   - Age 18 years or older

   - All genders and ethnicity

   - Positive HBsAg

   - HBeAg positive and negative

   - Pretreatment HBV DNA of 10,000 copies/mL or higher (for purposes of this study, both
   copies and equivalent IU measurements will be recorded and analyzed)

   - Patients who are switched to, or prescribed, entecavir after treatment with adefovir
   for at least 12 weeks by the providing physician.

   - Patients with and without prior lamivudine exposure will be enrolled but enrollment of
   lamivudine experienced cases will be limited to no more than 30 patients total

KEY EXCLUSION CRITERIA:

   - Patients who refused to consent to the study

   - Patients younger than 18

   - Vulnerable subjects such as pregnant women, prisoners, employees, patients with
   significant cognitive deficits.

   - Patients with prior exposure to another nucleoside for more than 2 weeks. Those with
   prior exposure to lamivudine will be enrolled under conditions detailed above.

   - HIV co-infection

   - HCV co-infection

   - HDV co-infection

   - Recipients of solid organ transplantation

   - Patients who receive high-dose steroid (60 mg/d or higher and for longer than 10 days)

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mindie H. Nguyen, MD
650-498-7878
Not Recruiting