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Immune-tolerant patients with chronic hepatitis B (CHB) awaiting assisted reproduction (AR) are required to initiate antiviral therapy due to laboratory safety. Additionally, rapid virus elimination is suggested to faciliate timely performance of AR. However, no consensus is reached regarding the antiviral therapy in this group. This study aimed to explore the efficacy and safety of tenofovir (TDF) and telbivudine (LdT) in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COM | Experimental | COM group receives combination therapy of tenofovir and telbivudine (TDF and LdT) for at least 48 weeks |
|
| TDF | Active Comparator | TDF group receives single therapy of tenofovir (TDF) for at least 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir and telbivudine | Drug | tenofovir and telbivudine administered at least 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HBV DNA < 500 Copies/mL at Week 12 | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HBV DNA < 500 Copies/mL at Week 24, 36 and 48 | Week 24, 36 and 48 | |
| Number of Participants With Normal Alanine Aminotransferase (ALT) at Week 12, 24, 36 and 48 | Week 12, 24, 36 and 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dongliangli Li, Dr. | Department of Hepatobiliary Disease | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuzhou General Hospital, Xiamen Univ | Fuzhou | Fujian | 350025 | 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 |
| D000077712 | Telbivudine |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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| Tenofovir | Drug | tenofovir administered at least 48 weeks |
|
|
| Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 12, 24, 36 and 48 | Week 12, 24, 36 and 48 |
| Number of Participants With Seroconversion to Antibody Against HBeAg (AntiHBe) at Week 12, 24, 36 and 48 | Week 12, 24, 36 and 48 |
| Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12, 24, 36 and 48 | Week 12, 24, 36 and 48 |
| Number of Participants With Seroconversion to Antibody to HBsAg (AntiHBs) at Week 12, 24, 36 and 48 | Week 12, 24, 36 and 48 |
| Occurrence of HBV Resistance Mutations | Baseline to Week 48 |
| off-treatment recurrence of HBV | Week 72 to 96 |
| Down syndrome Occurrence | week 13 of pregnancy |
| Fetal Malformations Occurrence | week 26 of pregnancy |
| 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 |
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |