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Liver fibrosis caused by hepatitis B virus (HBV) infection is easy to progress to liver cirrhosis and liver cancer, with great harm and poor therapeutic effect. Nucleos(t)ide analogues (NAs) are the most commonly anti-HBV drugs currently . Long-term use of NAs can inhibit HBV DNA and achieve the purpose of reducing poor prognosis. However, adverse prognosis, such as liver cirrhosis and liver cancer, cannot be completely eliminated even under the status of virologic inhibition under THE action of NAs. Current studies have shown that the lower the HBV surface antigen (HBsAg) is, the better the long-term prognosis is. As another anti-HBV drug, pegylated-interferon-α (peg-IFN-α) has the immune regulation effect that NAs do not have, which can bring irreplaceable effects in HBsAg reduction and liver fibrosis reversal. Therefore, the combined therapy of NAs and peg-IFN-α is a hot issue in the field of liver diseases over the world, but the research and application of the combined therapy in patients with liver fibrosis are very few. The preliminary results of our previous research showed that the combined therapy of peg-IFN-α and NAs in patients with HBV related fibrosis were safe, and had a significant effect on HBsAg decline. On this basis, this study intends to carry out a multicentre, non-randomized concurrent controlled trial, comparing the safety and efficacy between combined therapy (peg-IFN-α plus tenofovir) and tenofovir monotherapy in patients with liver fibrosis, especially focusing on HBsAg's decline and clearance, and the improvement of liver fibrosis degree, in order to find a better therapy, and to guide the clinical decision making.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TDF group | Active Comparator | tenofovir 300mg taken orally per day. |
|
| peg-IFN-α plus TDF group | Experimental | peg-IFN-α 180ug given subcutaneous injection per week combined with tenofovir 300mg taken orally per day . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-Interferon Alfa, Tenofovir Disoproxil Fumarate | Drug | Combination therapy group was treated with PEG-interferon Alfa in addition to TDF monotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| proportion of HBsAg seroclearance/seroconversion | proportion of seroclearance or seroconversion of HBV surface antigen compared with baseline | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of HBsAg seroclearance/seroconversion | Proportion of seroclearance or seroconversion of HBV surface antigen compared with baseline | 96 weeks |
| proportion of fibrosis improvement | Proportion of patients with improved fibrosis compared with baseline |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Third Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510630 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34697111 | Derived | Zhu S, Wu L, Mei Y, Liu Z, Lin L, Yuan J, Li J, Li X, Peng L. Prospective, multicentre, randomised controlled trial comparing the seroclearance of HBsAg between combination therapy of peg-interferon alpha and tenofovir with tenofovir monotherapy in nucleos(t)ide analogue-experienced patients with HBV-related liver fibrosis: a study protocol. BMJ Open. 2021 Oct 25;11(10):e049104. doi: 10.1136/bmjopen-2021-049104. |
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| Tenofovir Disoproxil Fumarate | Drug | TDF monotherapy |
|
| 96 weeks |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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