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

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ClinicalTrials.gov Identifier: NCT00704106
Recruitment Status : Completed
First Posted : June 24, 2008
Last Update Posted : November 14, 2022
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Pacific Health Foundation

Study Description
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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.

Condition or disease Intervention/treatment
Hepatitis B Drug: 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 Design
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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: HBV Viral Suppression by Entecavir in Adefovir Partial Responders
Study Start Date : May 2008
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Entecavir

Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. HBV DNA PCR after 24 weeks of entecavir from the time of medication switching. [ Time Frame: 48 weeks or after ]
  2. HBV DNA PCR after 48 weeks of entecavir from the time of medication switching. [ Time Frame: 48 weeks or after ]
  3. BR and CR at 24 and 48 weeks of therapy with entecavir. [ Time Frame: 48 weeks or after. ]
  4. BR and CR for longer duration of therapy if available. [ Time Frame: 48 weeks or after. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00704106


Locations
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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
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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
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pacific Health Foundation
ClinicalTrials.gov Identifier: NCT00704106    
Other Study ID Numbers: PHF008
First Posted: June 24, 2008    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022
Keywords provided by Pacific Health Foundation:
Hepatitis B
HBV
Treatment
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Anti-Infective Agents