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

Completed

• Conditions: Hepatitis B
• Interventions: Drug: Entecavir

• Registration Number: NCT00704106
• Lead Sponsor: Pacific Health Foundation

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-20
• Study First Submitted QC: 2008-06-23
• Study First Posted: 2008-06-24
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-10
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Entecavir	\<2 log IU/mL drop from initial HBVDNA after 12 weeks of adefovir
Group 1	Entecavir	Persistent viremia after 48 weeks or longer.
Group 3	Entecavir	Patients who responded to adefovir and were switched to entecavir.
Group 4	Entecavir	Patients with 160 copies/mL (100 IU/mL) or higher at the time of medication switch.

Primary Outcome Measures

Name	Time	Method
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.	48 weeks or after

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Stanford University Medical Center; 🇺🇸 Palo Alto, California, United States

San Jose Gastroenterology; 🇺🇸 San Jose, California, United States

Asian Village Medical Clinic; 🇺🇸 Chicago, Illinois, United States

Digestive Health Associates of Texas; 🇺🇸 Plano, Texas, United States

Houston Gastroenterology Clinic; 🇺🇸 Houston, Texas, United States