Status:
COMPLETED
Suboptimal Responders to Adefovir Switching to Entecavir
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief Summary
Switching to Entecavir will result in superior antiviral efficacy as compared to continuing with Adefovir in patients with a suboptimal response to Adefovir
Eligibility Criteria
Inclusion
- Chronic infection with hepatitis B virus (HBV)(detectable hepatitis B surface antibody (HBsAg) at screening and at least 24 weeks prior to screening, or detectable HBsAg for \<24 weeks and negative for immunoglobulin M core antibody)
- Documentation of hepatitis B e antigen (HBeAg) positive or negative status
- Naive to nucleoside/nucleotide analogues, with the exception of adefovir
- Suboptimal response to adefovir treatment
- No lamivudine/telbivudine, entecavir, or adefovir resistance-associated substitutions at screening
- Male or female gender, aged 16 years and older
- Compensated liver function
- Serum alanine aminotransferase level \<10\*upper limit of normal at screening
Exclusion
- Women who are pregnant or breastfeeding
- Evidence of decompensated cirrhosis
- Coinfection with HIV, hepatitis C virus, or hepatitis D virus
- Recent history of pancreatitis (within 24 weeks prior to the first dose of study medication)
- Chronic renal insufficiency, defined as a creatinine clearance \<50 mL/min
- Current abuse of illegal drugs or alcohol, sufficient in the investigator's opinion to prevent adequate compliance with study therapy or to increase the risk of hepatotoxicity or pancreatitis
- Other serious medical conditions that might preclude completion of this study or that require chronic administration of prohibited medications
- Serum creatinine level \>1.5 mg/dL; hemoglobin level \<10.0 g/dL; platelet count \<70,000/mm\^3; absolute neutrophil count \<1500 cells/mm\^3; serum alpha fetoprotein level \>100 ng/mL
- Except adefovir, any prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B (eg, lamivudine, entecavir), or any other experimental anti-HBV antiviral, or any China Traditional Medicine
- Therapy with interferon, thymosin alpha, or other immunostimulators within 24 weeks of randomization
- Required chronic administration of medications that cause immunosuppression, that are associated with a high risk of nephrotoxicity or hepatotoxicity, or that affect renal excretion.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT00718887
Start Date
July 1 2008
End Date
January 1 2011
Last Update
February 11 2013
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Local Institution
Beijing, Beijing Municipality, China, 100011
2
Local Institution
Guiyang, Guizhou, China, 550004
3
Local Institution
Nanjing, Jiangsu, China, 210002
4
Local Institution
Nanchang, Jiangxi, China, 330006