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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2015

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.

Interventions

  • Drug: Emtricitabine
    • emtricitabine were given to each patients from week 28 pregnancy to 24 weeks after delivery

Arms, Groups and Cohorts

  • Experimental: Chinese naive pregnant HBsAg positive patients
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • HBsAg positive rate in newborns
    • Time Frame: week48 after delivery
    • HBsAg positive rate in newborns

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Asian-Pacific Alliance of Liver Disease, Beijing
  • Collaborator
    • Beijing Ditan Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jun Cheng, M.D., Principal Investigator, Asian Pacific Alliance of Liver Diseases, Beijing
  • Overall Contact(s)
    • Jun Cheng, M.D., +86 10 84322116, jun.cheng.ditan@gmail.com

References

Gish RG, Leung NW, Wright TL, Trinh H, Lang W, Kessler HA, Fang L, Wang LH, Delehanty J, Rigney A, Mondou E, Snow A, Rousseau F. Dose range study of pharmacokinetics, safety, and preliminary antiviral activity of emtricitabine in adults with hepatitis B virus infection. Antimicrob Agents Chemother. 2002 Jun;46(6):1734-40.

Lim SG, Ng TM, Kung N, Krastev Z, Volfova M, Husa P, Lee SS, Chan S, Shiffman ML, Washington MK, Rigney A, Anderson J, Mondou E, Snow A, Sorbel J, Guan R, Rousseau F; Emtricitabine FTCB-301 Study Group. A double-blind placebo-controlled study of emtricitabine in chronic hepatitis B. Arch Intern Med. 2006 Jan 9;166(1):49-56.

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