Status:
COMPLETED
Genes Involved in Resistance or Susceptibility to Hepatitis B Virus
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Hepatitis, Viral, Human
Eligibility:
All Genders
8-90 years
Brief Summary
This study, conducted by the Beijing University First Hospital of China and the National Cancer (NCI), will try to identify genes associated with either susceptibility or resistance to chronic infecti...
Detailed Description
Persistent hepatitis B viral (HBV) infection is a significant public health problem because of the occurence of chronic liver disease, cirrhosis, and hepatocarcinoma (HCC) \[1-3\]. Roughly one-third o...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- A Group - HBV Clearance:
- HBsAg negative and anti-HBs and anti-HBc positive or anti-HBs positive and no HB Vaccination history.
- No systemic diseases.
- B Group - Asymptomatic persistent infection:
- HBsAg, anti-HBc positive for at least 6 months.
- At least one parent or sibling HBsAG positive .
- ALT and AST have been in normal range (less than 45 IU/L) at least 5 years
- No clinical symptoms of hepatitis.
- No clinical liver cirrhosis.
- C Group - Chronic Hepatitis B:
- HBsAg, anti-HBc positive for more than 6 months.
- At least one parent or sibling HBsAg positive.
- ALT and/or AST were greater than or equal to 60 IU/L or greater than 2 times upper limit of normal.
- No clinical liver cirrhosis.
- No other systemic diseases.
- D Group - Decompensated liver cirrhosis:
- HBsAg and anti-HBc positive.
- At least one parent or sibling HbsAg positive.
- Decompensated liver cirrhosis (gastroesophageal varication, ascites or edema)
- E Group - Primary hepatocellular carcinoma:
- HbsAg or anti-HBc positive.
- At least one parent or sibling HBsAg positive.
- HCC confirmed by liver biopsy or by both AFP an ultrasound, CT or MRI.
- F Group - Normal Donor Group:
- HbsAg negative and anti-HBc and anti-HBs negative
- ALT and AST are in normal range (less than 45 IU/L)
- No systemic diseases.
- Offspring of cases (for haplotype determinations):
- Natural child of cases.
- Age 8 or older.
- EXCLUSION CRITERIA:
- B thru E Groups:
- Persons born in 1963 or later.
- Persons not of Han ethnicity.
- Persons with no first-order relative (parent or sibling) with HBV infection.
- Persons who resided in Fusui County of Guangzi Zhuang Autonomous Region or in the Qidong district of Jiangsu Province for at least 6 months prior to 1986.
- anti-HCV, HCV RNA, anti-HDV, and/or HDAg.
- Current infection with HAV or HEV (indicated by antibodies and abnormal liver function).
- Persons meeting the inclusion criteria but who are unwilling or unable to give informed consent.
- A \& F Groups - HBV Clearance \& Normal Donors:
- Persons born in 1963 or later.
- Persons not of Han ethnicity.
- Persons who resided in Fusui County of Guangxi Zhuang Autonomous Region or in the Qidong district of Jiangsu Province for at least 6 months prior to 1986.
- Anti-HCV, HCV RNA, anti-HDV and/or HGAg positive.
- Current infection with HAV or HEV (indicated by antibodies and abnormal liver function).
- Persons meeting the inclusion criteria but who are unwilling or unable to give informed consent.
Exclusion
Key Trial Info
Start Date :
September 27 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 22 2018
Estimated Enrollment :
2303 Patients enrolled
Trial Details
Trial ID
NCT00342186
Start Date
September 27 2002
End Date
February 22 2018
Last Update
June 16 2020
Active Locations (1)
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1
Peking University First Hospital
Beijing, China