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

Hepatitis B Clinical Trial

— NAs resistance  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02791386
• Other study ID #: AI463-508
• Status: Completed
• Phase: N/A
• First received: June 1, 2016
• Last updated: November 9, 2017
• Start date: November 22, 2016
• Est. completion date: October 30, 2017

Study information

• Verified date: November 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 383
• Est. completion date: October 30, 2017
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic
• Recurrence

Locations

Country	Name	City	State
China	Local Institution	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Retrospectively collected from March 31, 2008 to August 15, 2016
Primary	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		Retrospectively collected from March 31, 2008 to August 15, 2016
Secondary	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		Retrospectively collected from March 31, 2008 to August 15, 2016
Secondary	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		Retrospectively collected from March 31, 2008 to August 15, 2016
Secondary	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		Retrospectively collected from March 31, 2008 to August 15, 2016
Secondary	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		Retrospectively collected from March 31, 2008 to August 15, 2016
Secondary	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		Retrospectively collected from March 31, 2008 to August 15, 2016
Secondary	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		Retrospectively collected from March 31, 2008 to August 15, 2016

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form