HBeAg-positive Chronic Hepatitis B
Conditions
Interventions
part I:2 team
part II:3 weeks / time, a total of 3 times
Sponsors
First Hospital Peking University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Part I (1) Healthy subjects aged 20-50 years old; (2) normal physical examination, mood, lung and other organ damage, liver, kidney, coagulation tests and blood, urine and other tests were no abnormal clinical significance; (3) HBV serological markers (HBsAg, HBsAb, HBcAb, HBe-Ag, HBeAb) all negative, and never injected with hepatitis B vaccine; (4) HLA*0201 positive. Part II (1) Age 18-65 years old, male or female; (2) diagnosis of chronic hepatitis B and HBV-DNA greater than 105 copies / ml, HBeAg-positive, alanine aminotransferase (ALT) of 1.3-8 times the upper limit of normal in between; (3) normal physical examination, mood, lung and other organ damage, renal function, coagulation tests and blood, urine and other tests no abnormal clinical significance; (4) WBC greater than 3.5*10^9/L and neutrophils greater than 1.5*10^9/L, platelets greater than 80*10^9/L; (5) Total bilirubin <=25ummol/L; (6) HLA*0201 positive.
Exclusion criteria
Exclusion criteria: (1) hepatitis C (HCV), HIV-positive; (2) clinically significant cardiovascular, respiratory, endocrine, metabolic, kidney, liver, gastrointestinal tract, skin, infection, cancer, hematological, neurological or psychiatric illness / functional disorders; (3) past history with the researchers that the disease should not participate in the trial; (4) 3 months participated in drug trials or other donors; (5) allergies or a history of drug allergy; (6) pregnant or lactating women and those planning a pregnancy; (7) first within one month of prescription medications received any clinical disease or infection; (8) subjects started taking drugs in the week before taking any medication, including non-prescription drugs and herbal medicines, but the vitamin and / or acetaminophen (paracetamol)except; (9) drinking history; smoking history; (10)HLA*0201 negative. Part II (1) Anti-HAVIgM, anti-HCV, anti-HDV and anti-HEV positive; (2) anti-CMVIgM, anti-EBVIgM and anti-HIV positive; (3) clinically significant cardiovascular, respiratory, endocrine, metabolic, renal, gastrointestinal, the skin, infections, cancer, blood, nerves or mental illness / functional disorders, primary liver disease*. (4) Some researchers believe that past history should not participate in the trial of the disease; liver cancer or liver cancer were suspected; (5) 3 months participated in drug trials or other blood donation; (6) within six months had used antiviral drugs and potent immune regulator; (7) allergies or a history of drug allergy; (8) pregnant, lactating or planning to become pregnant female patients; (9) HLA*0201 negative.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety indicators;Virological response;Immunological parameter; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver function;Immunological parameter; | — |
Countries
China
Contacts
Public ContactChongwen Si
Outcome results
None listed