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Hepatitis B Research Network Pediatric Cohort Study (HBRN)

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ClinicalTrials.gov Identifier: NCT01263600
Recruitment Status : Active, not recruiting
First Posted : December 20, 2010
Last Update Posted : January 16, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Anna Lok, University of Michigan

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.

Condition or disease
Hepatitis B

Detailed Description:

•Primary Aim:

o 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

Secondary Aims:

  • To describe clinical, virological, and immunological characteristics of participants with HBV in the US and Canada.
  • To evaluate changes in HBV infection status and hepatitis B surface antigen (HBsAg) levels and factors associated with those changes.
  • To verify whether a baseline HBsAg below 1,000 IU/mL and HBV DNA below 1,000 IU/mL is an accurate predictor of people who are, or who will become, inactive carriers, defined as people who are HBsAg positive, hepatitis B "e" antigen (HBeAg) negative, have normal alanine aminotransferase (ALT) and HBV DNA under 1,000 IU/mL on at least two occasions over a period of at least 6 months with HBV DNA under 1,000 IU/mL.
  • To assess the health related quality of life (HRQOL) of treatment naïve hepatitis B surface antigen (HBsAg) positive children and adolescents
  • To develop a bank of biospecimens (e.g., serum, plasma, DNA, liver tissue) obtained from participants with HBV infection.
  • To identify pediatric participants from 2 years to <18 years of age with chronic HBV infection for potential participation in treatment study to be conducted by the Hepatitis B Research Network (HBRN).

Study Type : Observational
Actual Enrollment : 463 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cohort Hepatitis B Virus (HBV) Pediatric Protocol
Study Start Date : December 2010
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Antigen loss: e and s [ Time Frame: up to 288 weeks ]
    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.


Secondary Outcome Measures :
  1. Hepatitis exacerbation marked by alanine aminotransferase (ALT) Flare [ Time Frame: up to 288 weeks ]
    A flare is defined as serum alanine aminotransferase (ALT) greater than or equal to 10 times the upper limit of normal which corresponds to (1 550 IU/L in females and 600 IU/L in males for 6 months - 18 months of age and 2) 350 IU/L in females and 400 IU/L in males for >18 months - < 18 years of age (12). Once a flare is detected, participants will be followed more closely until its resolution.

  2. Cirrhosis [ Time Frame: up to 288 weeks ]

    The diagnosis of cirrhosis will be made by (1) liver histology, when available or In the absence of histological diagnosis, cirrhosis is defined as any one of the following

    • Presence of ascites or hepatic hydrothorax
    • Variceal or portal hypertensive bleeding
    • Hepatic encephalopathy
    • Child-Turcotte-Pugh (CTP) score of 7 or above

    or in the absence of hepatic decompensation (any two of the following):

    • Splenomegaly
    • Nodular liver
    • Platelet count below 120,000/mm3

    Once cirrhosis is diagnosed, patient follow-up should include Hepatocellular carcinoma(HCC)surveillance


  3. Hepatic Decompensation [ Time Frame: up to 288 weeks ]

    It is likely that the development of cirrhosis and subsequent hepatic decompensation will be preceded and foreseen by the progression of fibrosis. Development of hepatic decompensation will be defined by any of the following events:

    • Ascites or hepatic hydrothorax
    • Variceal bleeding or portal hypertensive bleeding
    • Hepatic encephalopathy
    • Child-Turcotte-Pugh (CTP) score of 7 or above

    It is anticipated that there will be a small number of patients that will develop decompensation during the follow-up.


  4. Hepatocellular carcinoma (HCC) [ Time Frame: up to 288 weeks ]
    HCC may be detected by routine surveillance or may become clinically apparent. The diagnosis of HCC will be made using the American Association for the Study of Liver Disease criteria.

  5. Death [ Time Frame: up to 288 weeks ]
    Death may occur related to liver disease (typically hepatic decompensation or HCC) or may occur unrelated to hepatitis B or liver disease. Date and cause of death will be recorded.

  6. Liver transplantation [ Time Frame: up to 288 weeks ]
    Liver transplantation will be recorded upon notification. Date of transplantation, indication for transplantation, and occurrence of incidental HCC will be recorded. Follow-up ends with liver transplantation.

  7. Reaching 18 years of Age [ Time Frame: up to 288 weeks ]
    Patients who reach 18 years of age and are within an adult HBRN clinical center will be offered participation in the adult cohort study and re-consented for the adult protocol.


Biospecimen Retention:   Samples With DNA
Liver biopsy tissue, blood (serum, plasma, and DNA)


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Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients from Children's Hospitals and university medical centers in the United States and Canada
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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): NCT01263600


Locations
United States, California
University of California San Francisco Medical Center
San Francisco, California, United States, 94143
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Cardinal Glennon Children's Medical Center
Saint Louis, Missouri, United States, 63104
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75235
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98015
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5g1X8
Sponsors and Collaborators
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Steven Belle, PhD University of Pittsburgh

Additional Information:
Responsible Party: Anna Lok, Study Chair, University of Michigan
ClinicalTrials.gov Identifier: NCT01263600     History of Changes
Other Study ID Numbers: DK082864Pediatric
U01DK082916 ( U.S. NIH Grant/Contract )
U01DK082864 ( U.S. NIH Grant/Contract )
U01DK082874 ( U.S. NIH Grant/Contract )
U01DK082944 ( U.S. NIH Grant/Contract )
U01DK082843 ( U.S. NIH Grant/Contract )
U01DK082871 ( U.S. NIH Grant/Contract )
UL1TR000423 ( U.S. NIH Grant/Contract )
UL1TR000004 ( U.S. NIH Grant/Contract )
A-DK-3002-001 ( Other Identifier: Interagency Agreement )
First Posted: December 20, 2010    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Anna Lok, University of Michigan:
Hepatitis B
HBV
Pediatric

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections