NCT00342186

Genes Involved in Resistance or Susceptibility to Hepatitis B Virus

Completed Last updated 16 June 2020

What this trial tests

trial in Hepatitis, Viral, Human in 2,303 participants. Completed in 22 February 2018.

Timeline

27 September 2002

Primary endpoint
22 February 2018

22 February 2018

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	2,303
Start date	27 September 2002
Primary completion	22 February 2018
Estimated completion	22 February 2018
Sites	1 location across China

Conditions studied

• Hepatitis, Viral, Human — all drugs for Hepatitis, Viral, Human →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 8 to 90, any sex, with Hepatitis, Viral, Human. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 infection by the hepatitis B virus (HBV). Some people recover from HBV infection; others become chronically infected and may go on to develop severe liver disease such as cirrhosis or liver cancer. About 350 million people worldwide have chronic HBV infection. Of 120 million infected Chinese, 90 percent of children infected at less than 5 years of age and 10 percent of infected adults develop persistent infection.

HBV-infected and non-infected healthy persons of Han ethnicity born before 1963 may be eligible for this study. Offspring of infected candidates (born in any year) may also be enrolled. Infected adults must have at least one infected parent or sibling. Persons who resided in Fusui County of Guangxi Zhuang Autonomous Region or in the Qidong district of Jiangsu Province for at least 6 months before 1986 may not participate.

All participants (except offspring of the study subjects) will fill out a health questionnaire (providing information about eating, drinking, and smoking habits and a personal and family health history) and will donate no more than 20 milliliters of blood. The blood will be tested for antibodies, antigens, and other substances that may indicate infection with hepatitis viruses. Some of the blood will be sent to the NCI for DNA analysis to identify genetic factors that may influence clearance of the hepatitis virus after infection or progression to liver diseases associated with HBV infection. Infected patients who have had a liver biopsy in the past will be asked permission to examine tissue from the biopsy and to review laboratory results of any tests done for diagnostic and treatment purposes.

When the study is completed, specimens sent to the NCI will have identifiers linking the material to the donor removed. The anonymous samples may then be used for other genetic studies. Specimens remaining in China will continue to have identifiers linked to them and may be used for future studies designed to identify who is at greatest risk of developing serious liver diseases. Participants who do not want their blood used for future studies may request that the samples be destroyed.

Because children inherit one-half of their DNA from each parent, DNA samples from HBV infected study participants may provide additional information about the parent s DNA structure. Offspring who participate in this study will provide a DNA sample. The sample is obtained by swishing a mouthwash in the mouth for 30 seconds and then spitting the mouth wash into a cup. The DNA is then isolated from the mouth cells.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.