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Compared to TDF, peginterferon alfa 2a may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. We design this study to compare the effectiveness and safety between the combination therapy of TDF and peg-IFN with TDF alone in NAs experienced patients with HBV related liver fibrosis. Especially the improvement of liver fibrosis and the occurrence of long-term end-stage liver disease such as cirrhosis, liver cancer, etc.
Compared to TDF, peginterferon alfa 2a may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. We design this study to compare the effectiveness and safety between the combination therapy of TDF and peg-IFN with TDF alone in NAs experienced patients with HBV related liver fibrosis. Especially the improvement of liver fibrosis and the occurrence of long-term end-stage liver disease such as cirrhosis, liver cancer, etc.
Main purpose: Comparing the improvement rate of liver fibrosis. Secondary purpose: Comparing the incidence of adverse events. Comparing the incidence of cirrhosis, hepatocellular carcinoma, and liver failure.
Comparing the rates of HBsAg and HBeAg serological conversion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TDF group | Active Comparator | 93 patients would receive treatment of oral medication of tenofovir disoproxil fumarate (TDF) 300mg once per day from baseline to 48 weeks. Then they would receive oral medication of TDF 300 mg once per day from 49 to 96 weeks. |
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| Combination group | Active Comparator | 93 patients would receive treatment of subcutaneous injection of peginterferon alfa 2a 180 μg once per week and meanwhile oral medication of tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to 48 weeks. Then they would receive oral medication of TDF 300 mg once per day from 49 to 96 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir Disoproxil Fumarate | Drug | Oral medication of Tenofovir Disoproxil Fumarate 300mg once per day. |
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| Measure | Description | Time Frame |
|---|---|---|
| Ratio of regression of fibrosis | Regression of fibrosis was defined as liver stiffness measured by transient elastography changed from 9~12kpa to 6~9kpa or below, and from 6~9kpa to less than 6kpa. After treatment, the proportion of patients with regression of fibrosis in the two groups was the ratio of regression of fibrosis, separately. | 48 weeks; 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of loss of hepatitis b e antigen or/and seroconversion | Hepatitis b e antigen and hepatitis b e antibody would be tested to know the ratio of patients with negative hepatitis B e antigen and positive hepatitis B e antibody at 4 time points after anti-virus treatment. | 24 week, 48 week, 72 week, 96 week |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shu Zhu, Master | Contact | +8615626477267 | zhush8@mail2.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Peng, ph.D. | Third Affiliated Hospital, Sun Yat-Sen University | Study Director |
| Xu, ph.D. | Third Affiliated Hospital, Sun Yat-Sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Third Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510630 | China |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| C100416 | peginterferon alfa-2a |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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| PEG-Interferon alfa 2a | Drug | Subcutaneous injection of Peginterferon Alfa-2a 180 μg once per week. |
|
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| Ratio of loss of hepatitis b s antigen or/and seroconversion |
Hepatitis b s antigen and hepatitis b s antibody would be tested to know the ratio of patients with negative hepatitis B s antigen and positive hepatitis B s antibody at 4 time points after anti-virus treatment. |
| 24 week, 48 week, 72 week, 96 week |
| Logarithmic mean of HBsAg decline | Hepatitis b s antigen would be tested to know the decline of patients with positive hepatitis B s antigen at 4 time points after anti-virus treatment. | 24 week, 48 week, 72 week, 96 week |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |