DV2-HBV-27: Observational Pregnancy Registry

Pregnant Clinical Trial

— HBV-27  

Official title:

HEPLISAV-B Pregnancy Registry: An Observational Study on the Safety of HEPLISAV-B Exposure in Pregnant Women and Their Offspring

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03664648
• Other study ID #: DV2-HBV-27
• Status: Active, not recruiting
• Start date: February 21, 2021
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Dynavax Technologies Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Purpose of the study is to evaluate pregnancy outcomes among women who received a dose of HEPLISAV-B within 28 days prior to conception or at any time during pregnancy

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years and older

• HEPLISAV-B exposure within 28 days prior to conception or at any time during pregnancy

Exclusion Criteria:

• Less than 18 years of age

• HEPLISAV-B exposure greater than 28 days prior to conception

Related Conditions & MeSH terms

• Pregnant

Intervention

Biological:
• HEPLISAV-B
This study is strictly observational. Administration of HEPLISAV-B, the schedule of office visits and all treatment regimens will be determined by the treating health care provider in the context of routine clinical care.

Locations

Country	Name	City	State
United States	PPD Registry Office, Recruiting Nationwide	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Dynavax Technologies Corporation	PPD, Part of Thermo Fisher Scientific

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Major Congenital Malformations in Live-Born Infants.		Live-born infants will be followed to 12 months of age
Primary	Rate of Still Births, Pre-Term, or Fetal Loss (Including Spontaneous Abortion) of any Gestational Age		Follow-up will end at the time of pregnancy outcome up to 9 months