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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Pacific Health Foundation
ClinicalTrials.gov Identifier:
NCT00704106
First received: June 20, 2008
Last updated: May 8, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention
Hepatitis B
 Drug: Entecavir

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: HBV Viral Suppression by Entecavir in Adefovir Partial Responders

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pacific Health Foundation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HBV DNA PCR after 24 weeks of entecavir from the time of medication switching. [ Time Frame: 48 weeks or after ] [ Designated as safety issue: No ]
  • HBV DNA PCR after 48 weeks of entecavir from the time of medication switching. [ Time Frame: 48 weeks or after ] [ Designated as safety issue: No ]
  • BR and CR at 24 and 48 weeks of therapy with entecavir. [ Time Frame: 48 weeks or after. ] [ Designated as safety issue: No ]
  • BR and CR for longer duration of therapy if available. [ Time Frame: 48 weeks or after. ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: May 2008
Estimated Study Completion Date: December 2013
Groups/Cohorts Assigned Interventions
Group 1
Persistent viremia after 48 weeks or longer.
 Drug: Entecavir
0.5 or 1 mg dose qd
Other Name: 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 Name: Baraclude
Group 3
Patients who responded to adefovir and were switched to entecavir.
 Drug: Entecavir
0.5 or 1 mg dose qd
Other Name: 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 Name: Baraclude

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00704106

Locations
United States, California
Stanford University Medical Center
Palo Alto, California, United States, 94304
San Jose Gastroenterology
San Jose, California, United States, 95116
San Jose Gastroenterology
San Jose, California, United States, 95128
United States, Illinois
Asian Village Medical Clinic
Chicago, Illinois, United States, 60640
United States, Texas
Houston Gastroenterology Clinic
Houston, Texas, United States, 77072
Digestive Health Associates of Texas
Plano, Texas, United States, 75093
Sponsors and Collaborators
Pacific Health Foundation
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
  More Information

Publications:

Responsible Party: Pacific Health Foundation
ClinicalTrials.gov Identifier: NCT00704106     History of Changes
Other Study ID Numbers: PHF008
Study First Received: June 20, 2008
Last Updated: May 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Pacific Health Foundation:
Hepatitis B
HBV
Treatment

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
 Adefovir
Adefovir dipivoxil
Entecavir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on May 23, 2013