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

Recruitingn/aAges any - anyAllThe Task Force for Global Health
NCT05368974 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 demonstrated excellent safety and efficacy in non-pregnant individuals, but there is a lack of data regarding the safety of these medications in pregnant women and the effectiveness of these medications in reducing mother-to-child transmission. Therefore, although HCV screening during pregnancy is now recommended in many countries, there is no approved treatment for HCV during pregnancy. An observational study is here proposed to assess outcomes of mother-infant pairs exposed to DAAs during pregnancy within a global clinical case registry. Data regarding the exposures and outcomes of mother-infant pairs exposed to DAAs during pregnancy will be solicited and collected from clinical providers, health

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📋 Eligibility rules (as published)
Inclusion Criteria: -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 Criteria: \- DAA exposures that include ribavirin or interferon will be excluded given their established harm during pregnancy.
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What it tests

  • Direct Acting Antivirals
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Where

1 site
The Taskforce for Global Health
Atlanta, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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