Skip to main content
OpenTrials
Completed

NCT Number: NCT01726439

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution, Beijing, Beijing Municipality, China

Loading trial locations.

About this study

Sampling Method: Consecutive patient sampling

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Proportion of patients who achieve virology response (defined as HBV DNA < 300 copies/mL) by ETV monotherapy in comparison with LAM-based therapy

    Time frame: 48 weeks after initial NUC antiviral therapy

    Virology response is defined as Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) < 300 copies/mL by a highly sensitive assay such as Roche COBAS or Abbott Real Time Polymerase chain reaction (PCR) performed in a one central laboratory

Secondary outcomes

  1. Mean HBV DNA reductions after 48 weeks of treatment from baseline for ETV and LAM-based therapy patients (stratifying by the 3 LAM-based subgroups)

    Time frame: Baseline (Day 1) and 48 weeks

  2. Proportion of patients who achieve virology response by ETV in comparison with LAM-based therapy after 24 weeks and 96 weeks of treatment (stratifying by the 3 LAM based subgroups)

    Time frame: 24 weeks and 96 weeks

  3. Proportion of patients who modify their initial treatment options to manage suboptimal response or resistance after 24 weeks, 48 weeks, and 96 weeks of treatment among all treatment options

    Time frame: 24 weeks, 48 weeks and 96 weeks

  4. Proportion of patients who achieve virology response among other treatment options, including ADV, LdT, and combinations of NUCs, after 24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks of treatment

    Time frame: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks

    HBV DNA levels at week 24 will be analyzed at the laboratories of hospitals where the patients are treated while evaluation of HBV DNA levels after 48 and 96 weeks of treatment will be conducted at the central laboratory

  5. Cumulative incidence of patients who develop viral breakthrough and/or genotypic resistance

    Time frame: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks

  6. Cumulative incidence of clinical outcome (eg, HCC, death, decompensated cirrhosis) in ETV arm versus LAM-based and other treatment arms

    Time frame: 48 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A 5-year Prospective and Observational Study to Evaluate the Effectiveness of Nucleos(t)Ide Analogs (NUC) Therapy Among Chronic Hepatitis B (CHB) Patients Naive to NUC in Real World Practice at Hospitals in Tier 2 Cities in China (the EVOLVE Study)

Acronym: EVOLVE

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Nov 15, 2012
Registry last updated
Jul 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.