A Phase IIIb Study to Compare Entecavir Plus Tenofovir vs. Adefovir Added to Continuing Lamivudine Therapy in Adult Patients With Lamivudine-Resistant Hepatitis B Infection

Phase 3TerminatedNCT00605384

Bristol-Myers Squibb4 enrolled

Overview

The purpose of this clinical research study is to find out whether a combination of entecavir (ETV) plus tenofovir (TNF) works better against Hepatitis B virus than adefovir (ADV) added to continuing lamivudine (LVD) therapy in patients whose Hepatitis B virus (HBV) is resistant against lamivudine. The safety of this treatment will also be studied.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis B

Interventions

Entecavir + TenofovirDRUG

Tablets, Oral Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks

Adefovir + continuing LamivudineDRUG

Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Chronic HBV infection * History of lamivudine (LVD) treatment, and lamivudine resistance (LVDr), receiving LVD at screening visit * Compensated liver function * HBV DNA ≥ 172,000 IU/mL * Hepatitis B e-antigen (HBeAg)-positive or HBeAg-negative Exclusion Criteria: * Evidence of decompensated cirrhosis * Coinfection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis D virus (HDV) * Recent history of pancreatitis * Serum alpha fetoprotein \> 100 ng/mL * Except lamivudine, any prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B

Locations (29)

Cedars Sinai Medical Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

Number of Participants Who Achieved an Hepatitis B Virus DNA (HBV DNA) Level < 50 IU/mL at Week 48

using the Roche COBAS® TaqMan HBV Test for use with the High Pure System (HPS) assay, by Polymerase Chain Reaction (PCR); HBV DNA \< 50 IU/mL = approximately 300 copies/mL

Time frame: Week 48

Secondary Outcomes

Number of Participants Who Achieved an HBV DNA Level <50 IU/mL at Week 96

by PCR, using the Roche COBAS®TaqMan - HPS assay; HBV DNA \< 50 IU/mL = approximately 300 copies/mL.

Time frame: Week 96

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs or Laboratory Abnormalities

AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and/or is an important medical event.

Time frame: Day 1 through end of treatment (Week 100 +/- 5 days)

Number of Participants Who Achieved HBV DNA < the Lower Limit of Detection (LLD) at Weeks 48 and 96

by PCR, using the Roche for the Roche COBAS® TaqMan - HPS assay. LLD = 4.8 IU/mL (approximately 28 copies/mL)

Time frame: Week 48, Week 96

HBV DNA Values at Weeks 48 and 96

Number of Participants with HBV DNA \<LLD (4.8); LLD to \<50; 50 to \<172; 172 to \<1,720; 1,720 to \<17,200; and ≥17,200 IU/mL (\<LLD (28); 28 to \<300; 300 to \<1,000; 1,000 to \<10,000; 10,000 to \<100,000; and ≥100,000 copies/mL by PCR, using the Roche COBAS®TaqMan - HPS assay

Data from ClinicalTrials.gov

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