Entecavir Plus Adefovir Combination Therapy Versus Entecavir Monotherapy vs Therapy With Adefovir Plus Lamivudine for Chronic Hepatitis B Infected Subjects With Lamivudine-resistant Virus

Completed · Phase 3

Conditions studied: Hepatitis B, Chronic

In brief

The purpose of this study is to evaluate the effectiveness of entecavir plus adefovir combination therapy versus entecavir monotherapy or therapy with adefovir plus lamivudine

Key facts

Study ID

NCT00410202

Run by

Bristol-Myers Squibb

People needed

629

Starts

2008-03-01

Expected to finish

2012-07-01

Last updated by the study team

2013-11-21

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Evidence of lamivudine (LVD) resistance
• Subjects must have a history of previous LVD treatment at screening, and must have evidence of at least 1 LVD resistance substitution (valine, isoleucine, or serine) at reverse transcriptase codon 204 (M204V/I/S)
• Nucleoside- and nucleotide-naive, except for LVD, and had chronic hepatitis B (HBV) infection
• Compensated liver function and must have met 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)
• HBV DNA > 1.72 x 10*4* IU/mL (approximately 10*5* copies/mL)
• Documentation of hepatitis B e antigen (HBeAg) positive and hepatitis B e antibody (HBeAb) negative status at screening
• alanine aminotransferase (ALT) ≤ 10 * upper limit of normal (ULN) at screening
• Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study (and for up to 6 weeks after the last dose of investigational product) in such a manner that the risk of pregnancy is minimized
• WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal. Post menopausal is defined as:
• Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential
• WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 72 hours prior to the start of investigational product

You may not qualify if…

• Evidence of decompensated cirrhosis
• Coinfection with human immunodeficiency virus, hepatitis C virus , or hepatitis D virus
• Women who are pregnant or breastfeeding
• Sexually active fertile men not using effective birth control if their partners were WOCBP
• Laboratory values out of protocol-specified range

Where it is running

• Local Institution — Concord, New South Wales, Australia
• Local Institution — Randwick, New South Wales, Australia
• Local Institution — Porto Alegre Rs, Rio Grande do Sul, Brazil
• Local Institution — Calgary, Alberta, Canada
• Local Institution — Athens, Greece
• Local Institution — Hong Kong, Hong Kong, Hong Kong
• Local Institution — Shatin, New Territories, Hong Kong
• Local Institution — Tai Po, Hong Kong
• Local Institution — Lucknow, Uttar Pradesh, India
• Local Institution — Ahmedabad, India
• Local Institution — Chandigarh, India
• Local Institution — Indore, India
• Local Institution — Ludhiana, India
• Local Institution — New Delhi, India
• Local Institution — Vellore, India
• Local Institution — Jakarta, Indonesia
• Local Institution — Antella, Firenze, Italy
• Local Institution — Kota Kinabalu, Sabah, Malaysia
• Local Institution — Kuala Lumpur, Malaysia
• Local Institution — Cebu City, Philippines
• Local Institution — Manila, Philippines
• Local Institution — Chorzów, Poland
• Local Institution — Kielce, Poland
• Local Institution — Lodz, Poland
• University Of Connecticut Health Center — Farmington, Connecticut, United States

Full record on ClinicalTrials.gov

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