Observational Study of Children with Hepatitis B Virus Infection in North America: A Cohort study protocol of the Hepatitis B Research Network (HBRN)

Study ID
STU 082010-220

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern University Hospital—St. Paul
  • Children's Medical Center-Dallas

Contact
Laurie Rodgers-Augsutyniak
214-456-6095
laurie.rodgers-augustyniak@childrens.com

Principal Investigator
Norberto Rodriguez-Baez

Summary

Type of study
* Observational Cohort study
Patients with HBV infection will be identified by sites participating in the NIH-funded Hepatitis B
Research Network (HBRN). Consenting patients who meet entry criteria will undergo a baseline
evaluation. Those who are eligible for the treatment study being conducted by the network will be
approached about participating. If they are not eligible, unwilling to participate or have completed their
participation in the treatment study, they will be followed longitudinally to observe clinical outcomes
and changes in their virologic and immunologic status.
It is estimated that approximately 500 patients with HBV infection will be enrolled in the Cohort Study
over a period of approximately 24 months. They will be followed indefinitely until the conclusion of
the study, which is estimated to be up to 72 months.

Hepatitis B Research Network Observational Study Protocol Version 1.0 09/15/2010
o Inclusion criteria

* Written informed consent/assent as appropriate

* At least 6 months to and amp;lt;18 years of age
*
HBsAg-positive

o Exclusion criteria

* Hepatic decompensation

* Hepatocellular carcinoma (HCC)

* Liver transplantation

* Current Hepatitis B antiviral treatment (except pregnant females)

* Known coinfection with HIV (patients with HDV or HCV coinfection are not excluded)

* Medical or social condition which in the opinion of the principal investigator would
interfere with or prevent regular follow up.

* Unable or unwilling to return for regular follow-up

Briefly, the visit schedule will be at baseline, weeks 24 and 48 in the first year of enrollment and every
year in subsequent years. Variable follow up visits may be required if certain events are
encountered. For participants experiencing an ALT flare, as defined in section 3.2.1 and Appendix A,
follow up will be every 2-4 weeks until resolved and for HBeAg or HBsAg loss participants will be
asked to return in 12 and 24 weeks and then resume follow-up every 48 weeks. Up to 72 months.

Participant Eligibility

Inclusion criteria

* Written informed consent/assent as appropriate

* At least 6 months to <18 years of age

* HBsAg-positive