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Rescue Treatment Pattern, Drug Resistance Recurrence, and Direct Medical Costs Associated With Chinese Patients With Chronic Hepatitis B and Drug Resistance to Nucleot(s)Ide Analogue Therapy

Completed
Conditions
Hepatitis B
Registration Number
NCT02791386
Lead Sponsor
Bristol-Myers Squibb
Brief Summary

The purpose of this study is to describe current rescue treatment pattern for nucleot(s)ide analogue (NA) resistance and assess the real-world treatment outcomes and health resources utilization of rescue treatments for drug resistance in a clinical cohort of Chinese patients with chronic hepatitis B (CHB).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
383
Inclusion Criteria
  • CHB patient with drug resistance confirmed by hepatitis B virus (HBV) gene mutation and virological breakthrough
  • Patient receiving rescue treatments for drug resistance to previous NA therapy for CHB
  • Patient who was regularly followed at least every 6 months for drug resistance at the tertiary liver clinic of SXH
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Exclusion Criteria
  • Patient with a diagnosis of hepatocellular carcinoma, decompensated cirrhosis, and/or liver transplantation prior to the development of drug resistance to NA therapy for CHB
  • Patient with co-infection with hepatitis C virus, hepatitis D virus, and/or human immunodeficiency virus
  • Patient with life expectancy less than 6 months after the date of the first laboratory test indicating drug resistance

Other protocol defined inclusion/exclusion criteria could apply

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Rescue treatments effect on direct medical costs associated with CHB patients who were followed for drug resistance to NA therapy at the tertiary liver clinic of SXHRetrospectively collected from March 31, 2008 to August 15, 2016
Direct medical costs associated with CHB patients who were regularly followed for drug resistance to NA therapy at the tertiary liver clinic of the Second Xiangya Hospital (SXH) in Changsha, Hunan, ChinaRetrospectively collected from March 31, 2008 to August 15, 2016
Secondary Outcome Measures
NameTimeMethod
Biochemical response recurrence associated with rescue treatments for drug resistance to NA therapy in CHB patients who were followed at the tertiary liver clinic of SXHRetrospectively collected from March 31, 2008 to August 15, 2016
Rescue treatment patterns associated with CHB patients who were regularly followed for their drug resistance to NA therapy at the tertiary liver clinic of SXHRetrospectively collected from March 31, 2008 to August 15, 2016
Rescue treatments effect on liver-related complications in CHB patients who were followed up for drug resistance to NA therapy at the tertiary liver clinic of SXHRetrospectively collected from March 31, 2008 to August 15, 2016
Drug resistance recurrence associated with rescue treatments for drug resistance to NA therapy in CHB patients who were followed at the tertiary liver clinic of SXHRetrospectively collected from March 31, 2008 to August 15, 2016
Rescue treatments effect on mortality in CHB patients who were followed up for drug resistance to NA therapy at the tertiary liver clinic of SXHRetrospectively collected from March 31, 2008 to August 15, 2016
Virological response recurrence associated with rescue treatments for drug resistance to NA therapy in CHB patients who were followed at the tertiary liver clinic of SXHRetrospectively collected from March 31, 2008 to August 15, 2016

Trial Locations

Locations (1)

Local Institution

🇨🇳

Changsha, Hunan, China

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