Emtricitabine for Prevention of Vertical Transmission of HBV in Chinese Pregnant HBsAg Positive Patients

Study Overview
=================
Brief Summary
-----------------
This study evaluates generic emtricitabine(FTC) efficacy and safety in Chinese naive pregnant HBsAg positive patients in prevention of HBV vertical transmission. Single group patients were enrolled to receive emtricitabine till 24 weeks after delivery.

Detailed Description
-----------------
Single group patients were enrolled to receive emtricitabine till 24 weeks after delivery, which include HBeAg positive patients. Patients and their newborns were followed till 48 weeks after delivery to evaluate the efficacy of prevention of vertical transmission.

Official Title
-----------------
Emtricitabine for Prevention of Vertical Transmission of HBV in Chinese Pregnant HBsAg Positive Patients

Conditions
-----------------
Hepatitis B, Chronic, Pregnancy

Intervention / Treatment
-----------------
* Drug: Emtricitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
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 paitents Diagnosed as ≥ 28 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
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chinese naive pregnant HBsAg positive patients<br>single group patients were enrolled to receive emtricitabine(200mg one time per day) till 24 weeks after dilivery,patients and followed up for 24 weeks. | Drug: Emtricitabine<br>* emtricitabine were given to each patients from week 28 pregnancy to 24 weeks after delivery<br>* Other names: Brand name：Huierding;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBsAg positive rate in newborns | HBsAg positive rate in newborns | week48 after delivery | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis B virus, Emtricitabine, Pregnancy, Vertical transmission