Hepatitis B, Chronic
Conditions
Brief summary
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.
Interventions
DRUGTenofovir and telbivudine
tenofovir and telbivudine administered at least 48 weeks
DRUGTenofovir
tenofovir administered at least 48 weeks
Sponsors
Fuzhou General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With HBV DNA < 500 Copies/mL at Week 12 | week 12 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Percentage of Participants With HBV DNA < 500 Copies/mL at Week 24, 36 and 48 | Week 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 |
| Number of Participants With Seroconversion to Antibody to HBsAg (AntiHBs) at Week 12, 24, 36 and 48 | Week 12, 24, 36 and 48 |
Countries
China
Outcome results
None listed