Clinical trial NCT02791386: 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
Official title: 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 Monotherapy: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-06-06
Enrollment: 383
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic

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).


Eligibility criteria: 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

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

Primary outcomes:
measure: 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, China
timeFrame: Retrospectively collected from March 31, 2008 to August 15, 2016
measure: 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 SXH
timeFrame: Retrospectively collected from March 31, 2008 to August 15, 2016
Secondary outcomes:
measure: Rescue treatment patterns associated with CHB patients who were regularly followed for their drug resistance to NA therapy at the tertiary liver clinic of SXH
timeFrame: Retrospectively collected from March 31, 2008 to August 15, 2016
measure: 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 SXH
timeFrame: Retrospectively collected from March 31, 2008 to August 15, 2016
measure: 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 SXH
timeFrame: Retrospectively collected from March 31, 2008 to August 15, 2016
measure: 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 SXH
timeFrame: Retrospectively collected from March 31, 2008 to August 15, 2016
measure: 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 SXH
timeFrame: Retrospectively collected from March 31, 2008 to August 15, 2016
measure: Rescue treatments effect on mortality in CHB patients who were followed up for drug resistance to NA therapy at the tertiary liver clinic of SXH
timeFrame: Retrospectively collected from March 31, 2008 to August 15, 2016
Other outcomes:
Locations:
city: Changsha
country: China
facility: Local Institution
state: Hunan
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: