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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01726439
First received: November 6, 2012
Last updated: September 24, 2014
Last verified: September 2014

November 6, 2012
September 24, 2014
December 2012
April 2016   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01726439 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Proportion of patients who achieve virology response by ETV in comparison with LAM-based therapy after 24 and 96 weeks of treatment (stratifying by the 3 LAM based subgroups) [ Time Frame: 24 weeks and 96 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients who modify their initial treatment options to manage suboptimal response or resistance after 24, 48, and 96 weeks of treatment among all treatment options [ Time Frame: 24 weeks, 48 weeks and 96 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients who achieve virology response among other treatment options, including ADV, LdT, and combinations of NUCs, after 24, 48 and 96 weeks of treatment [ Time Frame: 24 weeks, 48 weeks and 96 weeks ] [ Designated as safety issue: No ]
    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
  • Cumulative incidence of patients who develop viral breakthrough and/or genotypic resistance [ Time Frame: 48 weeks and 96 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effectiveness of Nucleos(t)Ide Analogs (NUC) Therapy Among Naive CHB Patients in China
A 2-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)

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

Sampling Method: Consecutive patient sampling

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Serum

Non-Probability Sample

Hospitals in Chinese tier 2 cities. The definition of these hospitals is the following:

  • Hospitals where 300 or more CHB patients are treated monthly
  • Hospitals where PCR can be performed in the hospital's laboratory to measure HBV DNA serum levels
Chronic Hepatitis B
Not Provided
CHB patients who are naive to NUC treatment
CHB patients who are naive to NUC at enrollment and be treated at hospitals at tier 2 cities in China
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3435
April 2016
April 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01726439
AI463-952
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP