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Observational Study of Direct-Acting Antivirals for Hepatitis C in Pregnancy

This study, called the "TiP-HepC Registry," is looking at the safety and effectiveness of Direct Acting Antivirals (DAAs) for pregnant women with Hepatitis C (HCV). Currently, there isn't an approved treatment for HCV during pregnancy, even though screening is recommended. This study aims to understand how DAAs affect both the mother and the baby when taken during pregnancy, and if they help reduce the chance of the baby getting HCV from the mother. You could be eligible if you are pregnant, have chronic HCV infection, and have been exposed to DAAs around the time of conception. The study will track the number of negative pregnancy and birth outcomes over one year to see how well these medications work and if they are safe. The study plans to include 100 participants, but its current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will collect information without giving specific treatments. It aims to include 100 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one year to measure pregnancy and birth outcomes.

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NCT05368974

The Treatment in Pregnancy for Hepatitis C ("TiP-HepC") Registry

Recruiting
Not specifiedAll AgesObservational
The Task Force for Global Health
~100 participants
Updated 2024-12-18 on ClinicalTrials.gov
What's tested:Direct Acting Antivirals

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of adverse pregnancy outcomes
Measured over 1 year
+1 more outcome measured

Conditions

Hepatitis C

Explore related trials

Hepatitis C InfectionHepatitis C Infection

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • John Ward, MD · PRINCIPAL_INVESTIGATOR · The Taskforce For Global Health

Who to contact

Neil Gupta, MD
[email protected]
4043014134
Email the study team

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Do you actually qualify for this trial?

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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.

What this trial measures

  • Number of adverse pregnancy outcomes1 year

    The primary outcomes measured in the study are adverse pregnancy and birth outcomes documented at the time of the outcome of the pregnancy (primary endpoint). Primary adverse pregnancy outcomes include preterm delivery (\<37 weeks gestational age), stillbirth or fetal demise, and maternal death.

  • Number of adverse birth outcomes1 year

    Primary adverse birth outcomes include low birth weight (\<2500g), small for gestational age, need for neonatal intensive care, and presence of congenital anomaly.