Overview

This trial is active, not recruiting.

Condition hepatitis b
Treatment entecavir
Sponsor Pacific Health Foundation
Collaborator Bristol-Myers Squibb
Start date May 2008
End date December 2013
Trial size 120 participants
Trial identifier NCT00704106, PHF008

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Arm
Persistent viremia after 48 weeks or longer.
entecavir Baraclude
0.5 or 1 mg dose qd
<2 log IU/mL drop from initial HBVDNA after 12 weeks of adefovir
entecavir Baraclude
0.5 or 1 mg dose qd
Patients who responded to adefovir and were switched to entecavir.
entecavir Baraclude
0.5 or 1 mg dose qd
Patients with 160 copies/mL (100 IU/mL) or higher at the time of medication switch.
entecavir Baraclude
0.5 or 1 mg dose qd

Primary Outcomes

Measure
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 Outcomes

Measure
HBV DNA PCR after 24 weeks of entecavir from the time of medication switching.
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
BR and CR at 24 and 48 weeks of therapy with entecavir.
time frame: 48 weeks or after.
BR and CR for longer duration of therapy if available.
time frame: 48 weeks or after.

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title HBV Viral Suppression by Entecavir in Adefovir Partial Responders
Principal investigator Huy N Trinh, M.D.
Description Amendment was made, and approved by WIRB in January 2009, to this protocol: We propose a largely retrospective study with short-term prospective follow-up in a subgroup of patients who have not yet been treated with 96 weeks of entecavir following adefovir treatment. The aim of the study is to describe sequential virologic response to adefovir and entecavir.
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by Pacific Health Foundation.