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Completed

NCT Number: NCT03426618

A Real-World Observational Study for the Safety and Efficacy of Baraclude in Korean Pediatric Patients With Chronic Hepatitis B

This is a local, prospective observational study (regulatory post marketing surveillance) to access the safety and effectiveness of Baraclude in Korean pediatric patients with chronic HBV infection who are between the ages of 2 and less than 16 years.

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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

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed informed consent
  • 2 to < 16 years of age
  • Patients with chronic hepatitis B infection, eligible for treatment with Baraclude as indicated in the locally approved prescribing information

Exclusion criteria

  • Off-label use of the approved label in Baraclude pediatric indication
  • Patients with a contraindication for the use of Baraclude as described in the locally approved prescribing information

Other protocol defined inclusion/exclusion criteria could apply

Treatment and study plan

Non-Interventional

Other

Non-interventional

Primary outcomes

  1. Number of Adverse Events (AEs)

    Time frame: Up to 52 weeks

Secondary outcomes

  1. Participants who achieved a virologic response

    Time frame: Up to 48 weeks

    Measured by reduction in hepatitis B virus DNA to <300 copies/mL

  2. Mean log reduction in hepititis B virus DNA

    Time frame: Baseline to Weeks 12, 24, and 48

  3. Liver stiffness

    Time frame: Baseline and Week 48 of treatment

  4. Number of participants with resistance to Baraclude

    Time frame: Up to 52 weeks

  5. Number of participants with virologic relapse in participants

    Time frame: Up to 48 weeks

    Viral load of less than or equal to 300 copies/mL

  6. Number of participants with virologic Relapse in participants

    Time frame: Up to 48 weeks

    Viral load greater than 10,000 copies/mL

  7. Number of participants who were HBeAg seroconverted at Week 48

    Time frame: Week 48

  8. Number of participants who had HBeAg loss at week 48

    Time frame: Week 48

  9. Number of participants who were HBsAg seroconverted at Week 48

    Time frame: Week 48

  10. Number of participants who had HBsAg loss at week 48

    Time frame: Week 48

  11. Number of participants with normalization of serum ALT at week 12

    Time frame: Baseline to week 12

    Normalization is measured as less than or equal to 1 X the upper limit of normal of serum ALT

  12. Number of participants with normalization of serum ALT at week 24

    Time frame: Baseline to week 24

    Normalization is measured as less than or equal to 1 X the upper limit of normal of serum ALT

  13. Number of participants with normalization of serum ALT at week 48

    Time frame: Baseline to week 48

    Normalization is measured as less than or equal to 1 X the upper limit of normal of serum ALT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Real-World Observational Study for the Safety and Efficacy of Baraclude (Entecavir) in Korean Pediatric (Aged 2-16 Years) Patients With Chronic Hepatitis B

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 8, 2018
Registry last updated
Jun 3, 2019

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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