NCT01263600

Brief Summary

The purpose of this study is to describe participants 6 months to \<18 years of age with hepatitis B virus (HBV) infection in a prospective cohort in the United States (US) and Canada and identify predictors of disease activation and progression.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
462

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Longer than P75 for all trials

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 20, 2010

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2021

Completed
Last Updated

May 31, 2022

Status Verified

May 1, 2022

Enrollment Period

10.5 years

First QC Date

December 14, 2010

Last Update Submit

May 26, 2022

Conditions

Hepatitis B

Keywords

Hepatitis BHBVPediatric

Outcome Measures

Primary Outcomes (1)

  • Antigen loss: e and s

    Loss of these viral markers may be associated with appearance of corresponding antibodies in serum (anti-HBe or anti-HBs). HBsAg loss appears to represent a "cure" of HBV infection and is associated with reduction, but not necessarily elimination, of the risk of future complications, such as Hepatocellular carcinoma (HCC) which may occur, particularly in those who lose HBsAg at an older age (after 50 years) or after the development of cirrhosis. When HBeAg or HBsAg loss occurs, participants will be followed more closely initially and then return to the regular follow-up schedule.

    up to 288 weeks

Secondary Outcomes (7)

  • Hepatitis exacerbation marked by alanine aminotransferase (ALT) Flare

    up to 288 weeks

  • Cirrhosis

    up to 288 weeks

  • Hepatic Decompensation

    up to 288 weeks

  • Hepatocellular carcinoma (HCC)

    up to 288 weeks

  • Death

    up to 288 weeks

  • +2 more secondary outcomes

Eligibility Criteria

Age6 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients from Children's Hospitals and university medical centers in the United States and Canada

You may qualify if:

  • Written informed consent/assent as appropriate
  • At least 6 months to \<18 years of age
  • Hepatitis B surface antigen (HBsAg) positive

You may not qualify if:

  • Hepatic decompensation
  • Hepatocellular carcinoma (HCC)
  • Liver transplantation
  • Current Hepatitis B antiviral treatment (except pregnant females)
  • Known coinfection with HIV (patients with hepatitis D or hepatitis C 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of California San Francisco Medical Center

San Francisco, California, 94143, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Cardinal Glennon Children's Medical Center

St Louis, Missouri, 63104, United States

Location

University of Texas Southwestern

Dallas, Texas, 75235, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98015, United States

Location

Hospital for Sick Children

Toronto, Ontario, M5g1X8, Canada

Location

Related Publications (1)

  • Di Bisceglie AM, King WC, Lisker-Melman M, Khalili M, Belle SH, Feld JJ, Ghany MG, Janssen HLA, Lau D, Lee WM, Ling SC, Cooper S, Rosenthal P, Schwarz KB, Sterling RK, Teckman JH, Terrault N; Hepatitis B Research Network (HBRN). Age, race and viral genotype are associated with the prevalence of hepatitis B e antigen in children and adults with chronic hepatitis B. J Viral Hepat. 2019 Jul;26(7):856-865. doi: 10.1111/jvh.13104. Epub 2019 May 2.

    PMID: 30974509DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Liver biopsy tissue, blood (serum, plasma, and DNA)

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Steven Belle, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Chair

Study Record Dates

First Submitted

December 14, 2010

First Posted

December 20, 2010

Study Start

December 1, 2010

Primary Completion

June 9, 2021

Study Completion

June 9, 2021

Last Updated

May 31, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(6)CA(1)