TDF and LdT in Immune-tolerant CHB Patients Awaiting Assisted Reproduction

Study Overview
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Brief Summary
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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.

Official Title
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Combination Therapy of Tenofovir and Telbivudine in Immune-tolerant Patients With Chronic Hepatitis B Awaiting Assisted Reproduction

Conditions
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Hepatitis B, Chronic

Intervention / Treatment
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* Drug: Tenofovir and telbivudine
* Drug: Tenofovir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 18-45 years old with artificial reproductive needs Liver function (ALT) <40U/L for male and <30 for female HBV-DNA> 10e+5 HBVeAg + History> 0.5 years Exclusion Criteria: Cirrhosis Combined with other liver diseases such as autoimmune liver disease, alcoholic liver disease, fatty liver Liver or other parts of malignancies Bilirubin> 17.1 GGT> 2ULN Liver transplant patients combined HCV, HDV, HIV infection A history of anti-HBV drug resistance History of habitual abortion previous fetal malformation history CRP> 3.0ng / ml Uncontrolled hypertension Proteinuria or Calculated creatinine clearance < 70 mL/min Heart failure or acute coronary syndrome Coagulopathy Drug or alcohol addiction Hyperlipidemia LDL> 4.6 or TG> 2.0 Alphafetoprotein > 50 ng/mL Received interferon (pegylated or not) therapy within 6 months of the screening visit Evidence of hepatocellular carcinoma Received solid organ or bone marrow transplantation Was currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents Known hypersensitivity to the study drugs, the metabolites, or formulation excipients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COM<br>COM group receives combination therapy of tenofovir and telbivudine (TDF and LdT) for at least 48 weeks | Drug: Tenofovir and telbivudine<br>* tenofovir and telbivudine administered at least 48 weeks<br>* Other names: combination therapy;|
| Active Comparator: TDF<br>TDF group receives single therapy of tenofovir (TDF) for at least 48 weeks | Drug: Tenofovir<br>* tenofovir administered at least 48 weeks<br>* Other names: single therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With HBV DNA < 500 Copies/mL at Week 12 |  | week 12 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |