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Trial record 62 of 324 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03426618
Recruitment Status : Not yet recruiting
First Posted : February 8, 2018
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief 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.

Condition or disease Intervention/treatment
Hepatitis B Other: Non-interventional

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Anticipated Study Start Date : February 28, 2018
Estimated Primary Completion Date : December 28, 2018
Estimated Study Completion Date : December 28, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Entecavir
U.S. FDA Resources

Group/Cohort Intervention/treatment
Pediatric participants with Hepatitis B Virus (HBV)
All participants who received at least 1 dose of Baraclude.
Other: Non-interventional
Non-interventional



Primary Outcome Measures :
  1. Number of Adverse Events (AEs) [ Time Frame: Up to 52 weeks ]

Secondary Outcome Measures :
  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



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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be enrolled with chronic hepatitis B virus (CHB)between the ages of 2 and less than 16 years and who will begin treatment with Baraclude.
Criteria

Inclusion Criteria:

  • Signed informed consent
  • 2 to < 16 years of age
  • CHB (hepatitis B viral protein positive for at least 6 months)
  • Nucleoside-naive
  • Compensated liver function
  • Hepatitis B virus DNA replication (HBV DNA ≥ 104 copies/mL) and hepatic inflammation (elevated serum ALT: 1.5 to < 10 ULN)
  • In patients with liver cirrhosis: any detectable level of HBV DNA and ALT > 1.5 ULN

Exclusion Criteria:

  • Coinfected with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV)
  • Other forms of acute and chronic conditions that may cause increased ALT as determined by the investigators (eg, acute viral illness, Wilson Disease, other metabolic disorders, autoimmune hepatitis, alcoholic liver disease)
  • Known allergy to nucleoside analogues
  • Patients with prior treatment with any nucleoside agents > 12 weeks will be excluded from this study

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426618


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: please email Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #

Locations
Korea, Republic of
Local Institution Not yet recruiting
Seoul, Korea, Republic of
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03426618     History of Changes
Other Study ID Numbers: AI463-514
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Anti-Infective Agents