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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 November 2022
• Main ID: NCT00704106
• Date of registration: 20/06/2008
• Prospective Registration: No
• Primary sponsor: Pacific Health Foundation
• Public title: Hepatitis B Virus (HBV) Viral Suppression by Entecavir in Adefovir Partial Responders ADVPR
• Scientific title: HBV Viral Suppression by Entecavir in Adefovir Partial Responders
• Date of first enrolment: May 2008
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00704106
• Study type: Observational

Countries of recruitment

United States

Contacts

• Name: Mindie H Nguyen, M.D., M.A.S.
• Affiliation: Pacific Health Foundation

• Name: Huy N Trinh, M.D.
• Affiliation: Pacific Health Foundation

Key inclusion & exclusion criteria

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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hepatitis B

Intervention(s)

Drug: Entecavir

Primary Outcome(s)

HBV DNA PCR after 12 weeks of entecavir from the time of medication switching: percent of patients with <2log drop in HBV DNA and percent of patients with complete viral suppression during adefovir versus during entecavir. [Time Frame: 48 weeks or after]

Secondary Outcome(s)

BR and CR for longer duration of therapy if available. [Time Frame: 48 weeks or after.]

HBV DNA PCR after 24 weeks of entecavir from the time of medication switching. [Time Frame: 48 weeks or after]

BR and CR at 24 and 48 weeks of therapy with entecavir. [Time Frame: 48 weeks or after.]

HBV DNA PCR after 48 weeks of entecavir from the time of medication switching. [Time Frame: 48 weeks or after]

Secondary ID(s)

PHF008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bristol-Myers Squibb