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

NCT02327715 | Unknown Phase 4 DMC

• 1 other identifier: FTC-02-prevention
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis B, Chronic; Pregnancy

Keywords

Hepatitis B virus; Emtricitabine; Pregnancy; Vertical transmission

Outcome Measures

Primary Outcomes (1)

• HBsAg positive rate in newborns

  HBsAg positive rate in newborns

  week48 after delivery

Secondary Outcomes (8)

• birth defect in newborns

  0 weeks, week24 and week48 after delivery

• virological response rate

  week 24 after delivery

• HBV DNA decrease level

  week 24 after delivery

• biochemical response

  week 24 after delivery

• HBeAg loss

  week 24 after delivery

Study Arms (1)

Chinese naive pregnant HBsAg positive patients

EXPERIMENTAL

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.

Drug: Emtricitabine

Interventions

Emtricitabine DRUG

emtricitabine were given to each patients from week 28 pregnancy to 24 weeks after delivery

Also known as: Brand name：Huierding

Chinese naive pregnant HBsAg positive patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asian-Pacific Alliance of Liver Disease, Beijing: lead
• Beijing Ditan Hospital: collaborator
• Hebei Medical University Pharmaceutical Factory: collaborator
• National Health and Family Planning Commission, P.R.China: collaborator

Related Publications (2)

• 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.

  PMID: 12019083 BACKGROUND

• 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.

  PMID: 16401810 BACKGROUND

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B

Interventions

Emtricitabine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jun Cheng, M.D.

  Asian Pacific Alliance of Liver Diseases, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Cheng, M.D.

CONTACT

+86 10 84322116; jun.cheng.ditan@gmail.com

Song Yang, M.D.

CONTACT

+86 15011210692; sduyangsong@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: December 30, 2014
• Study Start: January 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2016
• Last Updated: December 30, 2014

Record last verified: 2014-12