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

NCT02327715 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2014-12-30

No results posted yet for this study

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

Interventions

DRUG

Emtricitabine

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

Sponsors & Collaborators

  • Beijing Ditan Hospital

    collaborator OTHER

  • Hebei Medical University Pharmaceutical Factory

    collaborator INDUSTRY

  • National Health and Family Planning Commission, P.R.China

    collaborator OTHER_GOV

  • Asian-Pacific Alliance of Liver Disease, Beijing

    lead OTHER

Principal Investigators

  • Jun Cheng, M.D. · Asian Pacific Alliance of Liver Diseases, Beijing

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-07-31
Completion
2016-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02327715 on ClinicalTrials.gov