Emtricitabine for Naive Chinese Pregnant Chronic Hepatitis B Patients

Study Overview
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Brief Summary
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This study evaluates generic emtricitabine(FTC) efficacy and safety in Chinese naive pregnant chronic hepatitis B patients. Single group patients were enrolled to receive emtricitabine till 48 weeks after delivery.

Detailed Description
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Single group patients were enrolled to receive emtricitabine till 48 weeks after delivery, which include HBeAg positive and negative patients.

Official Title
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Emtricitabine for Naive Chinese Pregnant Chronic Hepatitis B Patients

Conditions
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Hepatitis B, Chronic, Pregnancy

Intervention / Treatment
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* Drug: Emtricitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HBsAg positive for more than 6 months HBeAg positive patients: HBV DNA ≥ 5log10 copies/ml HBeAg postive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4 HBeAg negative patients: HBV DNA ≥ 4log10 copies/ml HBeAg postive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4 Nucleoside/nucleotide naive patients Diagnosed as ≥ 12 weeks pregnancy Exclusion Criteria: Diagnosed HCC with AFP and ultrasound, CT or MRI Creatine >130μmol/L or Ccr < 70mL/min Hemoglobin <100g/L Coinfected with HAV,HEV,HCV,HDV or HIV ANA > 1:100 Uncontrolled cardiovascluar diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer Drug abuse or alcohal addiction Previous history of taking agents of lamivudine, adefovir, tenofovir entecavir or telbivudine Long-term use of immunosuppressor or immunomodulator 6 months before enrollment to this trial Underwent liver transplantation or liver transplantation in schedule Allergic to nucleoside or nucleotide analogues Family history of genetic defects disease Abnormal results in fatal defects screening HBsAg positive sperm provider pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chinese naive pregnant chronice hepatitis B<br>Chinese naive pregnant chronice hepatitis B were enrolled to take emtricitabine (200 mg one time per day) till 48 weeks after delivery. | Drug: Emtricitabine<br>* emtricitabine were given to each patients at baseline till 48 weeks after delivery<br>* Other names: Brand name：Huierding;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| virological response rate | HBV DNA < 500 copies/ml | week 48 after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV DNA decrease level | HBV DNA decrease compared with baseline（log10 copies/ml） | week 24 and 48 after delivery | 
| virological response rate | HBV DNA < 500 copies/ml | week 24 after delivery | 
| biochemical response | ALT normalization | week 24 and 48 after delivery | 
| HBeAg loss | HBeAg loss in HBeAg positive group | week 24 and 48 after delivery | 
| HBeAg seroconversion | HBeAg seroconversion in HBeAg positive group | week 24 and 48 after delivery | 
| HBeAg reversion | HBeAg positive in Baseline HBeAg negativie group patients | week 24 and 48 after delivery | 
| HBsAg loss | HBsAg loss | week 24 and 48 after delivery | 
| HBsAg seroconversion | HBsAg loss and anti-HBs positive | week 24 and 48 after delivery | 
| HBV genetic resistance to emtricitabine | HBV genetic resistance to emtricitabine | week 24 and 48 after delivery | 
| adverse event | type and rate of adverse events;type and rate of severe adverse event; | week 24 and 48 after delivery | 
| birth defect in newborns | birth defect in newborns | 0 weeks, week24 and week48 after delivery | 
| HBsAg positive rate in newborns | HBsAg positive rate in newborns | 0 weeks, week24 and week48 after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B, chronic, Emtricitabine, Pregnancy