Hepatitis B Clinical Trial
Official title:
The Curative Effect and Security of Interferon Combined Resveratrol on HBeAg Positive Chronic Hepatitis B Patients - a Multi-center, Random, Control, Open Clinical Trial.
Verified date | May 2018 |
Source | First Hospital of Jilin University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to use Interferon Combined Resveratrol to treat patients with hepatitis B, which may provide a novel therapy target hepatitis B.
Status | Completed |
Enrollment | 228 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: Serologic evidence of chronic hepatitis B infection more than 6 months- HBeAg positive and HBeAb negative; HBV DNA=20000 IU/ml (equals to 105 copy/ml); 2×ULN =ALT=10×ULN,TBIL<2×ULN Exclusion Criteria: Has history of decompensated liver diseases Has been treated with other anti-virus drugs, or anti-tumor drugs, immuno-suppression drugs Has a history of autoimmune hepatitis History of a severe seizure disorder or current anticonvulsant use History or other evidence of a medical condition associated with chronic liver disease other than HBV which would make the patient, in the opinion of the investigator, unsuitable for the study (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures) History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
First Hospital of Jilin University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HBeAg seroconversion rate | HBeAg seroconversion rate | 48week |
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