CClinicalTrials.gg
Sign In
Status unknownNCT02327702Updated Dec 30, 2014

Emtricitabine for Naive Chinese Pregnant Chronic Hepatitis B Patients

A Phase 4 interventional study of Emtricitabine in Hepatitis B, Chronic and Pregnancy, sponsored by Asian-Pacific Alliance of Liver Disease, Beijing. Status unknown. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-30.

Sponsored by Asian-Pacific Alliance of Liver Disease, Beijing · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Hepatitis B, Chronic
  • Pregnancy

Keywords

  • Hepatitis B, chronic
  • Emtricitabine
  • Pregnancy
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's planned enrollment of 200 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Asian-Pacific Alliance of Liver Disease, Beijing is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Chinese naive pregnant chronice hepatitis B

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

    Drug: Emtricitabine

Interventions

  • DrugEmtricitabine

    emtricitabine were given to each patients at baseline till 48 weeks after delivery

    Also known as: Brand name：Huierding

06

What researchers measure

Primary outcomes

  1. virological response rate

    HBV DNA \< 500 copies/ml

    Time frame: week 48 after delivery

Secondary outcomes

  1. HBV DNA decrease level

    HBV DNA decrease compared with baseline（log10 copies/ml）

    Time frame: week 24 and 48 after delivery

  2. virological response rate

    HBV DNA \< 500 copies/ml

    Time frame: week 24 after delivery

  3. biochemical response

    ALT normalization

    Time frame: week 24 and 48 after delivery

  4. HBeAg loss

    HBeAg loss in HBeAg positive group

    Time frame: week 24 and 48 after delivery

  5. HBeAg seroconversion

    HBeAg seroconversion in HBeAg positive group

    Time frame: week 24 and 48 after delivery

  6. HBeAg reversion

    HBeAg positive in Baseline HBeAg negativie group patients

    Time frame: week 24 and 48 after delivery

  7. HBsAg loss

    HBsAg loss

    Time frame: week 24 and 48 after delivery

  8. HBsAg seroconversion

    HBsAg loss and anti-HBs positive

    Time frame: week 24 and 48 after delivery

  9. HBV genetic resistance to emtricitabine

    HBV genetic resistance to emtricitabine

    Time frame: week 24 and 48 after delivery

  10. adverse event

    type and rate of adverse events;type and rate of severe adverse event;

    Time frame: week 24 and 48 after delivery

  11. birth defect in newborns

    birth defect in newborns

    Time frame: 0 weeks, week24 and week48 after delivery

  12. HBsAg positive rate in newborns

    HBsAg positive rate in newborns

    Time frame: 0 weeks, week24 and week48 after delivery

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 12019083 ↗
  • 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. PubMed 16401810 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02327702
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
Responsible party
Sponsor
First posted
Dec 30, 2014
Start date
Jan 2015
Primary completion
Jul 2015 (estimated)
Completion
Jul 2017 (estimated)
Last update
Dec 30, 2014

Study contacts

Jun Cheng, M.D.
Contact
jun.cheng.ditan@gmail.com
+86 10 84322116
Song Yang, M.D.
Contact
sduyangsong@163.com
+86 15011210692
Jun Cheng, M.D.
principal investigator · Asian Pacific Alliance of Liver Diseases, Beijing

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hepatitis A→

Other studies from this sponsor

Asian-Pacific Alliance of Liver Disease, Beijing

Start the discussion