Clinical trial

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

Name

DV2-HBV-27

Description

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

Trial arms

Trial start

2021-02-21

Estimated PCD

2024-09-01

Trial end

2024-12-01

Status

Active (not recruiting)

Treatment

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.

Arms:

Adult Pregnant Women Exposed to HEPLISAV-B

Size

300

Primary endpoint

Rate of Major Congenital Malformations in Live-Born Infants.

Live-born infants will be followed to 12 months of age

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

Eligibility criteria

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '12 Months', 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}

Updated at

2023-09-18

1 organization

1 product

1 indication

Organization

Dynavax Technologies Corporation

Product

HEPLISAV-B

Indication

Pregnancy