Hepatitis B, Chronic Clinical Trial
Official title:
A Comparative Study of the Week 12 Antiviral Efficacy and Safety of Switching to Entecavir vs. Continuing Adefovir Treatment in Adults With Chronic Hepatitis B and Suboptimal Response to Adefovir
Verified date | January 2013 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
Switching to Entecavir will result in superior antiviral efficacy as compared to continuing with Adefovir in patients with a suboptimal response to Adefovir
Status | Completed |
Enrollment | 228 |
Est. completion date | January 2011 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Local Institution | Beijing | Beijing |
China | Local Institution | Changchun | Jilin |
China | Local Institution | Guiyang | Guizhou |
China | Local Institution | Nanchang | Jiangxi |
China | Local Institution | Nanjing | Jiangsu |
China | Local Institution | Shanghai | Shanghai |
China | Local Institution | Shanghai | Shanghai |
China | Local Institution | Shenyang | Liaoning |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants Who Achieved a Hepatitis B Virus (HBV) DNA Level <50 IU/mL at Week 12 by Polymerase Chain Reaction Testing | HBV DNA Level <50 IU/mL=approximately 300 copies/mL. | At Week 12 from Day 1 | No |
Secondary | Percentage of Participants Who Achieved an HBV DNA Level <50 IU/mL at Week 48 by Polymerase Chain Reaction Testing | HBV=hepatitis B virus. HBV DNA Level <50 IU/mL=approximately 300 copies/mL. | At Week 48 from Day 1 | No |
Secondary | Mean log10 Reduction From Baseline in Serum HBV DNA Level by Polymerase Chain Reaction Testing | HBV=hepatitis B virus | At Weeks 12 and 48 from Day 1 | No |
Secondary | Percentage of Participants Who Achieved Normalization of Alanine Aminotransferase (ALT) | ULN=upper limit of normal. ALT normalization= =1*ULN, among participants with baseline ALT >1*ULN | At Weeks 12 and 48 from Day 1 | No |
Secondary | Percentage of Participants With Loss of Hepatitis B e Antigen (HBeAg) and Hepatitis B e (HBe) Seroconversion | At Weeks 12 and 48 from Day 1 | No | |
Secondary | Number of Participants With Hepatitis B s Surface Antibody (HBsAG) Loss and HBsAG Seroconversion | At Weeks 12 and 48 from Day 1 | No | |
Secondary | Number of Participants With Genotypic Resistance to Entecavir | At Week 48 from Day 1 | No | |
Secondary | Number of Participants With Adverse Events, Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, Death as Outcome, Discontinuations Due to AEs, and Abnormalities in Laboratory Test Results (LTR) Leading to Discontinuation | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study drug. | Continually from Day 1 through Week 48, and through 24-week follow-up period | Yes |
Secondary | Percentage of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results | Hematology testing assessed levels of hemoglobin, white blood cells, platelets, neutrophils, international normalized ration, red blood cells, lymphocytes, and monocytes. | Day 1 through Week 48 | Yes |
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