Emtricitabine for Naive Chinese Pregnant Chronic Hepatitis B 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

NCT02327702

FTC-02-pregnant CHB patients

Details and patient eligibility

About

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.

Full description

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

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 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

Trial design

Primary purpose: Treatment

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 chronice hepatitis B

Experimental group

Description:

Chinese naive pregnant chronice hepatitis B were enrolled to take emtricitabine (200 mg one time per day) till 48 weeks after delivery.

Treatment:

Drug: Emtricitabine