DV2-HBV-27: Observational Pregnancy Registry

NCT ID: NCT03664648

Last Updated: 2023-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-21

Study Completion Date

2024-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Pregnant

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult Pregnant Women Exposed to HEPLISAV-B

Adult women who received a dose of HEPLISAV-B within 28 days prior to conception or at any time during pregnancy.

HEPLISAV-B

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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PPD, Part of Thermo Fisher Scientific

INDUSTRY

Sponsor Role collaborator

Dynavax Technologies Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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PPD Registry Office, Recruiting Nationwide

Wilmington, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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DV2-HBV-27

Identifier Type: -

Identifier Source: org_study_id

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