Trial record 64 of 443 for:    hepatitis b | Open Studies

Hepatitis B Research Network Pediatric Cohort Study (HBRN)

This study is currently recruiting participants.
Verified March 2013 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01263600
First received: December 14, 2010
Last updated: March 12, 2013
Last verified: March 2013
  Purpose

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
Hepatitis B

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cohort Hepatitis B Virus (HBV) Pediatric Protocol

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Antigen loss: e and s [ Time Frame: up to 288 weeks ] [ Designated as safety issue: No ]
    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:
  • Hepatitis exacerbation marked by alanine aminotransferase (ALT) Flare [ Time Frame: up to 288 weeks ] [ Designated as safety issue: No ]
    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.

  • Cirrhosis [ Time Frame: up to 288 weeks ] [ Designated as safety issue: No ]

    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


  • Hepatic Decompensation [ Time Frame: up to 288 weeks ] [ Designated as safety issue: No ]

    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.


  • Hepatocellular carcinoma (HCC) [ Time Frame: up to 288 weeks ] [ Designated as safety issue: No ]
    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.

  • Death [ Time Frame: up to 288 weeks ] [ Designated as safety issue: No ]
    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.

  • Liver transplantation [ Time Frame: up to 288 weeks ] [ Designated as safety issue: No ]
    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.

  • Reaching 18 years of Age [ Time Frame: up to 288 weeks ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 500
Study Start Date: December 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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).
  Eligibility

Ages Eligible for Study:   6 Months to 17 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01263600

Locations
United States, California
University of California San Francisco Medical Center Recruiting
San Francisco, California, United States, 94143
Contact: Philip Rosenthal, MD    415-476-7114    prosenth@peds.ucsf.edu   
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Kathleen Schwarz, MD    410-955-8769    kschwarz@jhmi.edu   
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Sarah Jane Schwarzenberg, MD    612-624-1133    schwa005@umn.edu   
United States, Missouri
Cardinal Glennon Children's Medical Center Recruiting
St. Louis, Missouri, United States, 63104
Contact: Jeffery Teckman, MD    314-577-5647    teckmanj@slu.edu   
United States, Texas
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75235
Contact: Norberto Rodriguez-Baez, MD    214-456-8000    norberto.rodriguez-baez@childrens.com   
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98015
Contact: Karen Murray, MD    206-987-1036    karen.murray@seattlechildrens.org   
Canada, Ontario
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5g1X8
Contact: Simon Ling, MD    416-813-7734    simon.ling@sickkids.ca   
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Steven Belle, PhD University of Pittsburgh
  More Information

Additional Information:
No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01263600     History of Changes
Other Study ID Numbers: DK082864Pediatric, U01DK082864
Study First Received: December 14, 2010
Last Updated: March 12, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Hepatitis B
HBV
Pediatric

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

ClinicalTrials.gov processed this record on April 16, 2014