Trials / Unknown
UnknownNCT03664648
DV2-HBV-27: Observational Pregnancy Registry
HEPLISAV-B Pregnancy Registry: An Observational Study on the Safety of HEPLISAV-B Exposure in Pregnant Women and Their Offspring
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- Dynavax Technologies Corporation · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-02-21
- Primary completion
- 2024-09-01
- Completion
- 2024-12-01
- First posted
- 2018-09-10
- Last updated
- 2023-09-18
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03664648. Inclusion in this directory is not an endorsement.