Trial record 6 of 112 for:    hepatitis b | Open Studies | United States

Hepatitis B Research Network Adult Cohort Study (HBRN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01263587
First received: December 14, 2010
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

The primary purpose of this study is to describe participants with hepatitis B virus (HBV) infection and identify factors that may cause the disease to activate or worsen.


Condition
Hepatitis B

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Persons With Hepatitis B Virus Infection in North America (Cohort Study)

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary 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 ALT greater than or equal to 10 times the upper limit of normal which corresponds to 300 IU/L in males or 200 IU/L in females. This definition will also be applied to hepatitis B surface antigen (HBsAg) positive pregnant women whose ALT levels increase during pregnancy or postpartum. Once a flare is detected, participants will be followed more closely until its resolution.

  • 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.

  • Cirrhosis [ Time Frame: up to 288 weeks ] [ Designated as safety issue: No ]
    Once cirrhosis is diagnosed, follow-up will include hepatocellular carcinoma (HCC) surveillance. HCC surveillance will also be performed in non-cirrhotic participants who meet American Association for the Study of Liver Disease guidelines criteria.

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

    Development of hepatic decompensation will be defined by any of the following events:

    • Ascites or hepatic hydrothorax
    • Variceal 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 participants who will develop hepatic decompensation during follow-up.


  • Hepatocellular carcinoma (HCC) [ Time Frame: up to 288 weeks ] [ Designated as safety issue: No ]
    Hepatocellular carcinoma (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 Hepatocellular carcinoma) 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 Hepatocellular carcinoma (HCC) will be recorded. Follow-up ends with liver transplantation.


Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 2500
Study Start Date: December 2010
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Detailed Description:

Aims

  • Primary Aim:

    o To describe participants 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 quantitative 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 transaminase (ALT) and HBV DNA under 1,000 IU/mL on at least two occasions over a period of at least 6 months
    • To develop a bank of biospecimens (e.g., serum, plasma, DNA, lymphocytes, liver tissue) obtained from participants with HBV infection
    • To identify participants with HBV infection who are potential candidates in one of the treatment studies to be conducted by the Hepatitis B Research Network (HBRN)
    • To describe the natural history of hepatitis B infection in pregnancy including the frequency of, and clinical and virological characteristics associated with, hepatic flares during pregnancy and post-partum.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population will be recruited from multi-site clinical centers in the United States and Canada including primary care hospitals and community centers.

Criteria

The study population will be recruited from multi-site clinical centers in the United States and Canada including primary care hospitals and community centers.

Inclusion criteria

  • Written informed consent
  • At least 18 years of age
  • Hepatitis B surface antigen (HBsAg) positive and either:

    • Pregnant
    • Anti-Hepatitis D positive
    • Diagnosed with acute Hepatitis B infection or experiencing a hepatitis flare
    • Immune tolerant or immune active phenotype
    • Potentially eligible for the Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B ancillary study (NCT01298037).

Exclusion Criteria:

  • Hepatic decompensation
  • Hepatocellular carcinoma (HCC)
  • Liver transplantation
  • Current hepatitis B antiviral treatment (except pregnant women and patients who are anti-HDV positive)
  • Known Human immunodeficiency virus (HIV) co-infection (patients with Hepatitis D (HDV) or Hepatitis C (HCV) co-infection are not excluded).
  • Medical or social condition which in the opinion of the investigator will interfere with or prevent follow-up per protocol
  • Unable or unwilling to return for follow-up visits
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01263587

Contacts
Contact: Michelle E Danielson, PhD 412-625-5555 danielsonm@edc.pitt.edu
Contact: Joan MacGregor, MS 412-624-4300 macgreg@edc.pitt.edu

Locations
United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Tram Tran, MD    310-423-1971    tram.tran@cshs.org   
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Steve Han, MD    310-206-0645    steven.han@ucla.edu   
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94115
Contact: Stewart Cooper, MD    415-600-1548    coopersl@sutterhealth.org   
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Norah Terrault    415-476-2227    norah.terrault@ucsf.edu   
United States, Hawaii
The Queen's Medial Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Naoky Tsai, MD    808-691-7609    naoky@hawaii.edu   
United States, Maryland
NIH Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: Marc Ghany, MD    301-402-5115    marcg@intra.niddk.nih.gov   
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Daryl Lau, MD    617-632-1098    dlau@bidmc.harvard.edu   
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Ray Chung, MD    617-724-7562    rtchung@partners.org   
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Anna Lok, MD    734-936-7511    aslok@med.umich.edu   
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Coleman Smith, MD    612-871-1145 ext 2908    smith146@umn.edu   
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Lewis R. Roberts, MB, ChB, PhD    507-538-4877    roberts.lewis@mayo.edu   
United States, Missouri
Saint Louis University Recruiting
St. Louis, Missouri, United States, 63104
Contact: Adrian Di Bisceglie, MD    314-577-8551    dibiscam@slu.edu   
Washington University Recruiting
St. Louis, Missouri, United States, 63108
Contact: Mauricio Lisker-melman, MD    314-747-3969    mlisker@dom.wustl.edu   
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Micheal Fried, MD    919-966-2516    michael_fried@med.unc.edu   
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Keyur Patel, MD    919-966-2616    kayur.patel@duke.edu   
United States, Texas
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: William M Lee, MD    214-645-6110    william.lee@utsouthwestern.edu   
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Contact: Robert Perrillo, MD    214-820-2956    RoberPer@BaylorHealth.edu   
United States, Virginia
Virginia Commonwealth University Medical Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Richard Sterling, MD    804-828-4060    rksterli@vcu.edu   
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Kris Kowdley    206-223-2319    kkowdley@benaroyaresearch.org   
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Robert Carithers, MD    206-598-4956    robertc@medicine.washington.edu   
Canada, Ontario
Toronto Western Hospital Liver Centre Recruiting
Toronto, Ontario, Canada
Contact: Harry Janssen, MD, PhD    416-603-5800 ext 2776    harry.janssen@uhn.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: NCT01263587     History of Changes
Other Study ID Numbers: DK082864, U01DK082864
Study First Received: December 14, 2010
Last Updated: May 7, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Hepatitis B
HBV
Cohort Study

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

ClinicalTrials.gov processed this record on October 22, 2014