A Comparative Study of Chronic Hepatitis B Subjects Treated with Entecavir Plus Tenofovir Combination Therapy vs Entecavir Monotherapy in Adults who are Treatment-Naïve to Nucleosides and Nucleotides: The BE-LOW Study - The BE-LOW Study

• Conditions: CHRONIC HEPATITIS B VIRUS,TREATMENT-NAIV; MedDRA version: 6.1Level: PTClassification code 10019731

• Registration Number: EUCTR2006-000421-62-IT
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 462

Inclusion Criteria

1)Signed written informed consent 2)Nucleoside- and nucleotide-naïve 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); 3)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) 4)For HBeAg-positive subjects, HBV DNA > 172,000 IU/mL (approximately 1,000,000 copies/mL) by PCR at screening; OR For HBeAg-negative subjects, HBV DNA >17,200 IU/mL (approximately 100,000 copies/mL) by PCR at screening; 5)ALT >= 1.3 x the ULN at screening and at least once >= 12 weeks prior to screening; 6)Males and females >= 16 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

1)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)WOCBP using a prohibited contraceptive method. At this time there are no known contraindicated contraceptives to entecavir or tenofovir; 3)Women who are pregnant or breastfeeding; 4)Women with a positive pregnancy test on enrollment or prior to investigational product administration; 5)Sexually active fertile men not using effective birth control if their partners are WOCBP; 6)Evidence of decompensated cirrhosis including but not limited to: variceal bleeding; hepatic encephalopathy; or ascites requiring management with diuretics or paracentesis; 7)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); 8)Recent history of pancreatitis (within 24 weeks prior to the first dose of study medication); 9)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; 10)Other serious medical conditions that might preclude completion of this study or that require chronic administration of prohibited medications (see Exclusion Criterion 19); 11)Serum creatinine > 1.5 mg/dL; 12)Hemoglobin < 10.0 g/dL; 13)Platelet count < 70,000/mm³; 14)Absolute neutrophil count < 1500 cells/mm³; 15)Serum alpha fetoprotein (AFP) level > 100 ng/mL; If the AFP level is between 21 and 100 ng/mL, it must be repeated prior to randomization. If the repeat AFP level is between 21 and 100 ng/mL, and if ultrasonography or computerized tomography (CT) of the liver performed prior to the first dose of study medication does not demonstrate a focal lesion suggestive of carcinoma, the subject may be dosed in the study; 16)Known history of allergy to nucleoside or nucleotide analogues; 17)Any prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B (e.g., adefovir, entecavir, famciclovir, tenofovir, telbivudine, clevudine, emtracitabine), or any other experimental anti-HBV antiviral; 18)Therapy with interferon; thymosin alpha or other immuno-stimulators within 24 weeks of randomization into this study; 19)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); 20)Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study; 21)Unable to tolerate oral medication; 22)Poor peripheral venous access

Study & Design

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