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Hepatitis B Virus (HBV) Viral Suppression by Entecavir in Adefovir Partial Responders (ADVPR)
This study is currently recruiting participants.
Study NCT00704106   Information provided by Pacific Health Foundation
First Received: June 20, 2008   Last Updated: June 23, 2008   History of Changes

June 20, 2008
June 23, 2008
May 2008
 
Our goal is to study patients with chronic hepatitis B, who have been switched to entecavir due to suboptimal treatment response with adefovir for a minimum of 12 weeks with < 2 log drop IU/mL or with persistent viremia after 48 weeks. [ Time Frame: 48 weeks or after ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00704106 on ClinicalTrials.gov Archive Site
  • Compare rate of complete response (CR) as measured by complete virologic and biochemical response at 24 and 48 weeks in patients who had been treated with adefovir for 24 and 48 weeks prior to switching. [ Time Frame: 48 weeks or after ] [ Designated as safety issue: No ]
  • Compare rates of biochemical response (BR) as measured by ALT normalization on the 2 different treatments at corresponding treatment milestones as above. [ Time Frame: 48 weeks or after ] [ Designated as safety issue: No ]
Same as current
 
Hepatitis B Virus (HBV) Viral Suppression by Entecavir in Adefovir Partial Responders
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.

 
 
Observational
Cohort, Other
Hepatitis B
Drug: Entecavir
  • Persistent viremia after 48 weeks or longer.
  • <2 log IU/mL drop from initial HBVDNA after 12 weeks of adefovir

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
80
January 2009
 

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 entecavir after treatment with adefovir for at least 12 weeks by the providing physician.
  • Less than a 2 log drop in HBV DNA from baseline at week 12.
  • Patient already on adefovir for 24 weeks and still have > or equal to 1000 copies/mL of HBV DNA.
  • Patients who still have positive HBV DNA PCR after 48 weeks or longer of adefovir.

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.
  • 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)
Both
18 Years and older
No
Contact: Long H Nguyen, B.A. 408-995-0333 longnguyen07@gmail.com
Contact: Nghi B Ha, B.S. 408-995-0333 nbha202@gmail.com
United States
 
NCT00704106
Huy N. Trinh/Mindie H. Nguyen, Pacific Health Foundation
PHF008
Pacific Health Foundation
Bristol-Myers Squibb
Principal Investigator: Huy N Trinh, M.D. Pacific Health Foundation
Principal Investigator: Mindie H Nguyen, M.D., M.A.S. Pacific Health Foundation
Pacific Health Foundation
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP