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

Asian-Pacific Alliance of Liver Disease, Beijing

Status and phase: Unknown; Phase 4

Conditions: Hepatitis B, Chronic; Pregnancy

Treatments: Drug: Emtricitabine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02327715

FTC-02-prevention

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Chinese naive pregnant HBsAg positive patients

Experimental group

Description:

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.

Treatment:

Drug: Emtricitabine