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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 3

Conditions: Chronic Hepatitis B

Treatments: Drug: Entecavir + Tenofovir; Drug: Adefovir + continuing Lamivudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00605384

AI463-137

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

4 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Entecavir + Tenofovir

2

Experimental group

Treatment:

Drug: Adefovir + continuing Lamivudine