A Comparative Study of the Antiviral Efficacy and Safety of Entecavir Plus Tenofovir versus Adefovir Added to Continuing Lamivudine in Adults with Lamivudine Resistant Chronic Hepatitis B Virus Infection. - ND

• Conditions: Hepatitis B Virus; MedDRA version: 9.1Level: LLTClassification code 10008910Term: Chronic hepatitis B

• Registration Number: EUCTR2007-001269-14-IT
• Lead Sponsor: BRISTOL-M.SQUIBB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-18
• Last Update Posted: 17 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

) Signed Written Informed Consent 2) Subjects with chronic HBV infection (detectable HBsAg at screening and for at least 24 weeks prior to screening, or detectable HBsAg for < 24 weeks and negative for IgM core antibody); subjects may be either HBeAg-positive or HBeAg-negative; 3) Subjects must have a history of previous lamivudine treatment, must have LVD resistance substitutions at reverse transcriptase rtM204I/V ± rtL180M, documented by INNO-Lipa HBV-DR assay, and must be receiving lamivudine at the screening visit; 4) Subjects must have compensated liver function and must meet ALL of the following criteria; International Normalization Ratio (INR) ≤ 1.5 Serum albumin ≥ 3 g/dL (≥ 30 g/L) Serum total bilirubin ≤ 2.5 mg/dL (≤ 42.75 μmol/L) 5) HBV DNA ≥ 172,000 IU/mL HBV DNA (approximately 106 copies/mL) by PCR at screening; 6) ALT >1.0 x and ≤10 x the ULN at screening and at least once ≥ 12 weeks prior to screening with no value falling within the normal reference range in the intervening period; 7) Men and women, ≥ 18 years of age (or minimum age of consent in a given country)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 6 weeks after the last dose of investigational product. 2) Evidence of decompensated cirrhosis including but not limited to: variceal bleeding; hepatic encephalopathy; or ascites requiring management with diuretics or paracentesis; 3) Coinfection with HIV, hepatitis C virus ([HCV]; coinfection is defined as HCV Ab-positive with detectable HCV ribonucleic acid [RNA] by PCR), or hepatitis D virus (HDV). 4) Recent history of pancreatitis (within 24 weeks prior to the first dose of study medication); 5) Currently abusing 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; 6) Other serious medical conditions that might preclude completion of this study or that require chronic administration of prohibited medications (see Exclusion Criteria 13 - 15). 7) Renal impairment that precludes subject from tolerating the per protocol study drug dose levels (see Protocol section 5.3.1). 8) Serum creatinine > 1.5 mg/dL; 9) Hemoglobin < 10.0 g/dL; 10) Platelet count < 70,000/mm3; 11) Absolute neutrophil count < 1500 cells/mm3; 12) Serum alpha fetoprotein (AFP) level > 100 ng/mL. 13) Known history of allergy to nucleoside or nucleotide analogues. 14) Except lamivudine, any prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B (e.g., adefovir, entecavir, famciclovir, tenofovir/emtricitabine, clevudine); 15) Therapy with interferon, thymosin alpha or other immuno-stimulators within 24 weeks of randomization into this study; 16) Required chronic administration of medications which cause immunosuppression or which are associated with a high risk of nephrotoxicity or hepatotoxicity or which affect renal excretion. (See Protocol Section 5.5.1 for examples.). 17) Prisoners or subjects who are involuntarily incarcerated; 18) Subject who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease); 19) Unable to tolerate oral medication; 20) Poor peripheral venous access; 21) Off lamivudine therapy for greater than 7 days between the time of the screening visit and initiation of study treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified