HBeAg Positive Chronic Hepatitis B Infection Clinical Trial
Official title:
Study the Effect of Nucleoside on Host Immune in Patients With CHB
| Verified date | November 2011 |
| Source | Changhai Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Food and Drug Administration |
| Study type | Interventional |
During hepatitis B virus(HBV) infection host immune plays important role.Recently there are many different antiviral therapy methods.Different antiviral therapy methods showed different effector.In order to investigate whether these antiviral therapy methods especially methods directly inhibit viral replication have some effect on host immune the investigators designed these study. The investigators want to observe the change of host immune during antiviral therapy in patients with chronic HBV infection, and analyze the relationship between these changes and the antiviral effector of these drugs.
| Status | Completed |
| Enrollment | 56 |
| Est. completion date | October 2011 |
| Est. primary completion date | October 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 66 Years |
| Eligibility |
inclusion criteria: - 18-65 years old - chronic HBV infection - HBeAg positive,HBV DNA more than 10E5 IU/mL - ALT =2×UTL exclusion criteria: - with liver cancer - with liver failure - pregnant |
Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| China | Changhai Hospital | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Cz Li |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | change of programmed death-1(PD-1) level of patients with chronic HBV infection during therapy | base line-4 weeks-12 weeks-24 weeks-end of therapy | Yes | |
| Secondary | Decline of hepatitis B e antigen (HBeAg) level | base line-4weeks-12weeks-24weeks-end of therapy | Yes |