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

November 10, 2022 updated by: Pacific Health Foundation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University Medical Center
      • San Jose, California, United States, 95116
        • San Jose Gastroenterology
      • San Jose, California, United States, 95128
        • San Jose Gastroenterology
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Asian Village Medical Clinic
    • Texas
      • Houston, Texas, United States, 77072
        • Houston Gastroenterology Clinic
      • Plano, Texas, United States, 75093
        • Digestive Health Associates of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • 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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Persistent viremia after 48 weeks or longer.
Drug: Entecavir
0.5 or 1 mg dose qd
Other Names:
  • Baraclude
Group 2
<2 log IU/mL drop from initial HBVDNA after 12 weeks of adefovir
Drug: Entecavir
0.5 or 1 mg dose qd
Other Names:
  • Baraclude
Group 3
Patients who responded to adefovir and were switched to entecavir.
Drug: Entecavir
0.5 or 1 mg dose qd
Other Names:
  • Baraclude
Group 4
Patients with 160 copies/mL (100 IU/mL) or higher at the time of medication switch.
Drug: Entecavir
0.5 or 1 mg dose qd
Other Names:
  • Baraclude

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
48 weeks or after

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pacific Health Foundation

Collaborators

Bristol-Myers Squibb

Investigators

  • Principal Investigator: Huy N Trinh, M.D., Pacific Health Foundation
  • Principal Investigator: Mindie H Nguyen, M.D., M.A.S., Pacific Health Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

June 20, 2008

First Submitted That Met QC Criteria

June 23, 2008

First Posted (Estimate)

June 24, 2008

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 10, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHF008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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