Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02327715
Recruitment Status : Unknown
Verified December 2014 by Asian-Pacific Alliance of Liver Disease, Beijing.
Recruitment status was:  Not yet recruiting
First Posted : December 30, 2014
Last Update Posted : December 30, 2014
Sponsor:
Collaborators:
Beijing Ditan Hospital
Hebei Medical University Pharmaceutical Factory
National Health and Family Planning Commission, P.R.China
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Pregnancy Drug: Emtricitabine Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Emtricitabine for Prevention of Vertical Transmission of HBV in Chinese Pregnant HBsAg Positive Patients
Study Start Date : January 2015
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Emtricitabine
emtricitabine were given to each patients from week 28 pregnancy to 24 weeks after delivery
Other Name: Brand name:Huierding




Primary Outcome Measures :
  1. HBsAg positive rate in newborns [ Time Frame: week48 after delivery ]
    HBsAg positive rate in newborns


Secondary Outcome Measures :
  1. birth defect in newborns [ Time Frame: 0 weeks, week24 and week48 after delivery ]
    birth defect in newborns

  2. virological response rate [ Time Frame: week 24 after delivery ]
    HBV DNA < 500 copies/ml

  3. HBV DNA decrease level [ Time Frame: week 24 after delivery ]
    HBV DNA decrease compared with baseline(log10 copies/ml)

  4. biochemical response [ Time Frame: week 24 after delivery ]
    ALT normalization

  5. HBeAg loss [ Time Frame: week 24 after delivery ]
    HBeAg loss in HBeAg positive patients

  6. HBeAg seroconversion [ Time Frame: week 24 after delivery ]
    HBeAg seroconversion in HBeAg positive group

  7. HBV genetic resistance to emtricitabine [ Time Frame: week 24 after delivery ]
    HBV genetic resistance to emtricitabine

  8. adverse event [ Time Frame: week 24 after delivery ]
    type and rate of adverse events;type and rate of severe adverse event



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02327715


Contacts
Layout table for location contacts
Contact: Jun Cheng, M.D. +86 10 84322116 jun.cheng.ditan@gmail.com
Contact: Song Yang, M.D. +86 15011210692 sduyangsong@163.com

Sponsors and Collaborators
Asian-Pacific Alliance of Liver Disease, Beijing
Beijing Ditan Hospital
Hebei Medical University Pharmaceutical Factory
National Health and Family Planning Commission, P.R.China
Investigators
Layout table for investigator information
Principal Investigator: Jun Cheng, M.D. Asian Pacific Alliance of Liver Diseases, Beijing

Publications:
Layout table for additonal information
Responsible Party: Asian-Pacific Alliance of Liver Disease, Beijing
ClinicalTrials.gov Identifier: NCT02327715    
Other Study ID Numbers: FTC-02-prevention
First Posted: December 30, 2014    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014
Keywords provided by Asian-Pacific Alliance of Liver Disease, Beijing:
Hepatitis B virus
Emtricitabine
Pregnancy
Vertical transmission
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Emtricitabine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents