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

Hepatitis B Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03426618
• Other study ID #: AI463-514
• Status: Completed
• Start date: January 12, 2018
• Est. completion date: March 13, 2019

Study information

• Verified date: May 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: March 13, 2019
• Est. primary completion date: March 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Non-interventional
Non-interventional

Locations

Country	Name	City	State
Korea, Republic of	Local Institution	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events (AEs)		Up to 52 weeks
Secondary	Participants who achieved a virologic response	Measured by reduction in hepatitis B virus DNA to <300 copies/mL	Up to 48 weeks
Secondary	Mean log reduction in hepititis B virus DNA		Baseline to Weeks 12, 24, and 48
Secondary	Liver stiffness		Baseline and Week 48 of treatment
Secondary	Number of participants with resistance to Baraclude		Up to 52 weeks
Secondary	Number of participants with virologic relapse in participants	Viral load of less than or equal to 300 copies/mL	Up to 48 weeks
Secondary	Number of participants with virologic Relapse in participants	Viral load greater than 10,000 copies/mL	Up to 48 weeks
Secondary	Number of participants who were HBeAg seroconverted at Week 48		Week 48
Secondary	Number of participants who had HBeAg loss at week 48		Week 48
Secondary	Number of participants who were HBsAg seroconverted at Week 48		Week 48
Secondary	Number of participants who had HBsAg loss at week 48		Week 48
Secondary	Number of participants with normalization of serum ALT at week 12	Normalization is measured as less than or equal to 1 X the upper limit of normal of serum ALT	Baseline to week 12
Secondary	Number of participants with normalization of serum ALT at week 24	Normalization is measured as less than or equal to 1 X the upper limit of normal of serum ALT	Baseline to week 24
Secondary	Number of participants with normalization of serum ALT at week 48	Normalization is measured as less than or equal to 1 X the upper limit of normal of serum ALT	Baseline to week 48

External Links

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