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Studies have shown that the HBeAg seroconversion rate of HBeAg positive chronic hepatitis B with tenofovir for one year's treatment was 17.8% and the negative conversion rate of their HBeAg and HBV DNA were 20.0% and 97.6%. The HBeAg Seroconversion rate of these patients was lower.Clinically, most patients need to take tenofovir for a long time, which may cause serious complications such as renal function damage,with decreased therapy compliance and Increased cost of treatment.In the course of tenofovir treatment, it is common that HBV-DNA negative patients with HBeAg Being down poor or staying at a low positive level for a long time keep taking the medicine. Therefore, it is Significant to Increase the HBeAg seroconversion rate of tenofovir during the clinical treatment.
Telbivudine has a strong antiviral effect.Studies have shown that the HBeAg seroconversion rate of HBeAg positive CHB for one year was 25%, which was higher than other nucleosides, and it could also improve the damaged renal function to a certain extent.The HBeAg seroconversion rate of patients with poor response to tenofovir for 12 months could be still poor if for 24 months . Therefore, this study is to observe the efficacy of these patients combined with telbivudine.
This is an open, multicenter, exploratory and real-world clinical study. It will be carried out in patients with poor response (HBV DNA > 2x103iu / ml) to tenofovir for 12 months. After one -week screening period, patients will be randomly assigned 1:1 to control and experimental groups. The control group takes tenofovir for 12 months while the experimental group takes tenofovir combined with telbivudinefor 12months .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental:person with TDF+LDT | TDF combined with LDT for 12 months |
| |
| Active comparator:person with TDF | TDF monotherapy was continued for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TDF | Drug | TDF combined with telbivudine (LDT) for 12 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| HBeAg seroconversion rates | HBeAg seroconversion rates at 12 months after tenofovir plus telbivudine treatment | 12months |
| HBeAg seroconversion rates | HBeAg seroconversion rates at 24 months after tenofovir plus telbivudine treatment | 24months |
| Measure | Description | Time Frame |
|---|---|---|
| HBeAg negative rate | HBeAg negative rate of tenofovir combined with telbivudine treatment at 12 and 24 months | 12 and 24months |
| ALT normalization rate | ALT normalization rate of tenofovir combined with telbivudine treatment at 12 and 24 months |
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Inclusion criteria:
Exclusion Criteria:
There are any other factors that the researcher thinks are not suitable for inclusion in the study, or that may affect the patient's participation or completion of the study.
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patients with poor response (HBV DNA > 2x103iu / ml) to tenofovir for 12 months
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chaoshuang Lin | Recruiting | Guangzhou | China |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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| Tenofovir Disoproxil Fumarate 300 MG |
| Drug |
TDF monotherapy was continued for 12 months |
|
| 12 and 24months |
| Renal function index | Renal function index of tenofovir combined with telbivudine treatment at 12 and 24 months | 12 and 24months |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |