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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 (NAs resistance)

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status

Completed

Conditions

Hepatitis B

Study type

Observational

Funder types

Industry

Identifiers

NCT02791386
AI463-508

Details and patient eligibility

About

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).

Enrollment

383 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

383 participants in 1 patient group

Chinese Patients With CHB and Drug Resistance to NA Therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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