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

Phase 4

• Conditions: Pregnancy; Hepatitis B, Chronic
• Interventions: Drug: Emtricitabine

• Registration Number: NCT02327715
• Lead Sponsor: Asian-Pacific Alliance of Liver Disease, Beijing

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.

Study Timeline

• Status Verified: 2014-12
• Study First Submitted: 2014-12-23
• Study First Submitted QC: 2014-12-29
• Last Update Submitted: 2014-12-29
• Study First Posted: 2014-12-30
• Last Update Posted: 2014-12-30
• Study Start: 2015-01
• Primary Completion: 2015-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chinese naive pregnant HBsAg positive patients	Emtricitabine	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.

Primary Outcome Measures

Name	Time	Method
HBsAg positive rate in newborns	week48 after delivery	HBsAg positive rate in newborns

Secondary Outcome Measures

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