Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03664648
Previous Study | Return to List | Next Study

DV2-HBV-27: Observational Pregnancy Registry (HBV-27)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03664648
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : July 18, 2019
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Dynavax Technologies Corporation

Brief 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

Condition or disease Intervention/treatment
Pregnant Biological: HEPLISAV-B

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: HEPLISAV-B Pregnancy Registry: An Observational Study on the Safety of HEPLISAV-B Exposure in Pregnant Women and Their Offspring
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis B

Group/Cohort Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. Rate of Major Congenital Malformations in Live-Born Infants. [ Time Frame: Live-born infants will be followed to 12 months of age ]
  2. Rate of Still Births, Pre-Term, or Fetal Loss (Including Spontaneous Abortion) of any Gestational Age [ Time Frame: Follow-up will end at the time of pregnancy outcome up to 9 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant Women
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Women 18 years of age or older exposed to HEPLISAV-B within 28 days of conception or at any time during pregnancy.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664648


Contacts
Layout table for location contacts
Contact: Deborah Covington, PhD 1-844-443-7734 heplisavbpregnancyregistry@ppdi.com
Contact: Randall Hyer, MD (510) 848- 5100 rhyer@dynavax.com

Locations
Layout table for location information
United States, North Carolina
PPD Registry Office, Recruiting Nationwide Recruiting
Wilmington, North Carolina, United States, 28401
Sponsors and Collaborators
Dynavax Technologies Corporation
PPD

Additional Information:

Layout table for additonal information
Responsible Party: Dynavax Technologies Corporation
ClinicalTrials.gov Identifier: NCT03664648     History of Changes
Other Study ID Numbers: DV2-HBV-27
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dynavax Technologies Corporation:
Pregnant
Conceived
HBV Vaccine
Hepatitis B
Hepatitis B vaccine
HBV
Hepatitis
Registry
Prevention
Female volunteers
Additional relevant MeSH terms:
Layout table for MeSH terms
Vaccines
Immunologic Factors
Physiological Effects of Drugs