Effectiveness of Nucleos(t)Ide Analogs (NUC) Therapy Among Naive CHB Patients in China (EVOLVE)

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Chronic Hepatitis B

Study type: Observational

Funder types: Industry

Identifiers

NCT01726439

AI463-952

Details and patient eligibility

About

To compare the effectiveness, in a real world practice setting in tier 2 cities of China, of Entecavir (ETV) monotherapy and Lamivudine (LAM) based therapies (including LAM monotherapy, de novo LAM + Adefovir [ADV] combination, and early add-on of ADV) among chronic hepatitis B (CHB) patients who are naive to NUC at enrollment to this study

Full description

Sampling Method: Consecutive patient sampling

Biospecimen Retention: Blood samples for HBV viral load testing along the treatment period of this study

Enrollment: 3,434 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CHB patients, or CHB patients with compensated cirrhosis, as defined by the current Chinese guidelines
• Male or female
• ≥ 18 years of age
• Either Hepatitis B e antigen (HBeAg) positive or negative
• Naïve to NUC (defined as no previous exposure to NUC treatment as based on patient self-report)
• Has compensated liver disease
• Patients with compensated cirrhosis
• Patients who consent to participate in this study
• Local residents with medical reimbursement coverage preferred

Exclusion criteria

• Co-infected with hepatitis C virus (HCV)
• CHB patients with decompensated cirrhosis, liver failure, hepatocellular carcinoma, or any other types of malignancy at the screening phase
• CHB patients who are being treated by interferon therapy within 6 months immediately prior to the screening phase of this study
• CHB patients with a confirmed pregnancy

Trial design

3,434 participants in 1 patient group

CHB patients who are naive to NUC treatment

Description:

CHB patients who are naive to NUC at enrollment and be treated at hospitals at tier 2 cities in China