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

Primary Purpose

Hepatitis B, Chronic, Pregnancy

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Emtricitabine
Sponsored by
Asian-Pacific Alliance of Liver Disease, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B, Chronic focused on measuring Hepatitis B virus, Emtricitabine, Pregnancy, Vertical transmission

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Chinese naive pregnant HBsAg positive patients

    Arm 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.

    Outcomes

    Primary Outcome Measures

    HBsAg positive rate in newborns
    HBsAg positive rate in newborns

    Secondary Outcome Measures

    birth defect in newborns
    birth defect in newborns
    virological response rate
    HBV DNA < 500 copies/ml
    HBV DNA decrease level
    HBV DNA decrease compared with baseline（log10 copies/ml）
    biochemical response
    ALT normalization
    HBeAg loss
    HBeAg loss in HBeAg positive patients
    HBeAg seroconversion
    HBeAg seroconversion in HBeAg positive group
    HBV genetic resistance to emtricitabine
    HBV genetic resistance to emtricitabine
    adverse event
    type and rate of adverse events;type and rate of severe adverse event

    Full Information

    First Posted
    December 23, 2014
    Last Updated
    December 29, 2014
    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
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02327715
    Brief Title
    Emtricitabine for Prevention of Vertical Transmission of HBV in Chinese Pregnant HBsAg Positive Patients
    Official Title
    Emtricitabine for Prevention of Vertical Transmission of HBV in Chinese Pregnant HBsAg Positive Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    July 2015 (Anticipated)
    Study Completion Date
    July 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the 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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis B, Chronic, Pregnancy
    Keywords
    Hepatitis B virus, Emtricitabine, Pregnancy, Vertical transmission

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Chinese naive pregnant HBsAg positive patients
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Emtricitabine
    Other Intervention Name(s)
    Brand name：Huierding
    Intervention Description
    emtricitabine were given to each patients from week 28 pregnancy to 24 weeks after delivery
    Primary Outcome Measure Information:
    Title
    HBsAg positive rate in newborns
    Description
    HBsAg positive rate in newborns
    Time Frame
    week48 after delivery
    Secondary Outcome Measure Information:
    Title
    birth defect in newborns
    Description
    birth defect in newborns
    Time Frame
    0 weeks, week24 and week48 after delivery
    Title
    virological response rate
    Description
    HBV DNA < 500 copies/ml
    Time Frame
    week 24 after delivery
    Title
    HBV DNA decrease level
    Description
    HBV DNA decrease compared with baseline（log10 copies/ml）
    Time Frame
    week 24 after delivery
    Title
    biochemical response
    Description
    ALT normalization
    Time Frame
    week 24 after delivery
    Title
    HBeAg loss
    Description
    HBeAg loss in HBeAg positive patients
    Time Frame
    week 24 after delivery
    Title
    HBeAg seroconversion
    Description
    HBeAg seroconversion in HBeAg positive group
    Time Frame
    week 24 after delivery
    Title
    HBV genetic resistance to emtricitabine
    Description
    HBV genetic resistance to emtricitabine
    Time Frame
    week 24 after delivery
    Title
    adverse event
    Description
    type and rate of adverse events;type and rate of severe adverse event
    Time Frame
    week 24 after delivery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jun Cheng, M.D.
    Phone
    +86 10 84322116
    Email
    jun.cheng.ditan@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Song Yang, M.D.
    Phone
    +86 15011210692
    Email
    sduyangsong@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jun Cheng, M.D.
    Organizational Affiliation
    Asian Pacific Alliance of Liver Diseases, Beijing
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12019083
    Citation
    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. doi: 10.1128/AAC.46.6.1734-1740.2002.
    Results Reference
    background
    PubMed Identifier
    16401810
    Citation
    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. doi: 10.1001/archinte.166.1.49.
    Results Reference
    background

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

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