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

Purpose

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

Condition
Chronic Hepatitis B

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Biospecimen Retention: Samples With DNA

Serum

Estimated Enrollment:	2288
Study Start Date:	December 2012
Estimated Study Completion Date:	August 2015
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts
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

Detailed Description:

Sampling Method: Consecutive patient sampling

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

CHB patients as defined by the 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)
Patients with decompensated cirrhosis, hepatocellular carcinoma, or any other types of malignancy at the screening phase
Any CHB patients who are being treated by interferon therapy at baseline

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726439

Contacts

Contact: For Site information please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial site that are recruiting have contact information at this time

Show 51 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT01726439 History of Changes
Other Study ID Numbers:	AI463-952
Study First Received:	November 6, 2012
Last Updated:	January 2, 2013
Health Authority:	China: Ministry of Health

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases

Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on June 18, 2013

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