Status:
RECRUITING
The Treatment in Pregnancy for Hepatitis C ("TiP-HepC") Registry
Lead Sponsor:
The Task Force for Global Health
Collaborating Sponsors:
Centers for Disease Control and Prevention
Conditions:
Hepatitis C
Eligibility:
All Genders
Brief Summary
Clinical interventions to reduce the risk of vertical transmission of hepatitis C virus (HCV) infection from mother to infant are highly limited. Direct-acting antiviral (DAA) medications have demonst...
Detailed Description
In 2016, approximately 6% of all women who were tested for HCV during pregnancy in the United States were HCV antibody-positive. That year, there were 14,417 live births delivered by HCV-positive wome...
Eligibility Criteria
Inclusion
- Documented pregnancy with: Estimated date of conception by documentation of either 1) date of last menstrual period or 2) ultrasound evaluation Actual date of delivery
- Documented chronic HCV infection prior to or during pregnancy (positive test for HCV RNA or HCV core antigen)
- Documented DAA exposure occurring within 30 days of the estimated date of conception and before the pregnancy outcome (ie, fetal demise, spontaneous abortion, live delivery, etc). Eligible DAA drugs are listed in Appendix 1.
Exclusion
- \- DAA exposures that include ribavirin or interferon will be excluded given their established harm during pregnancy.
Key Trial Info
Start Date :
February 11 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05368974
Start Date
February 11 2022
End Date
December 30 2026
Last Update
December 18 2024
Active Locations (1)
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1
The Taskforce for Global Health
Atlanta, Georgia, United States, 30030