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

BRISTOL-M.SQUIBB0 sites84 target enrollmentJuly 18, 2008

ConditionsHepatitis B Virus MedDRA version: 9.1Level: LLTClassification code 10008910Term: Chronic hepatitis B

DrugsVIREAD BARACLUDE*FL 30CPR RIV 1MG HEPSERA*1FL 30CPR 10MG ZEFFIX*28CPR RIV 100MG

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hepatitis B Virus
Sponsor: BRISTOL-M.SQUIBB
Enrollment: 84
Status: Active, not recruiting
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 18, 2008

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

BRISTOL-M.SQUIBB

Eligibility Criteria

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.