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NCT Number: 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

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).

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Changsha, Hunan, 410011, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: Retrospectively collected from March 31, 2008 to August 15, 2016

  2. 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

    Time frame: Retrospectively collected from March 31, 2008 to August 15, 2016

Secondary outcomes

  1. 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

    Time frame: Retrospectively collected from March 31, 2008 to August 15, 2016

  2. 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

    Time frame: Retrospectively collected from March 31, 2008 to August 15, 2016

  3. 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

    Time frame: Retrospectively collected from March 31, 2008 to August 15, 2016

  4. 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

    Time frame: Retrospectively collected from March 31, 2008 to August 15, 2016

  5. 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

    Time frame: Retrospectively collected from March 31, 2008 to August 15, 2016

  6. 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

    Time frame: Retrospectively collected from March 31, 2008 to August 15, 2016

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Acronym: NAs resistance

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 6, 2016
Registry last updated
Nov 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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