Emtricitabine for Naive Chinese Pregnant Chronic Hepatitis B Patients

• Status: Unknown status
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asian-Pacific Alliance of Liver Disease, Beijing
• Collaborators: Beijing Ditan Hospital; Hebei Medical University Pharmaceutical Factory; National Health and Family Planning Commission, P.R.China
• Treatments: Emtricitabine

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 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