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

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, healthcare facilities, HCV treatment programs, and other clinical practices worldwide. Data will be shared and maintained within a secure database, and cumulative data will be analyzed at pre-determined six-month intervals. The primary outcome will be the number and proportion of mother-infant pairs with adverse pregnancy or birth outcomes. The results of this study will inform HCV treatment decisions by clinical providers and programs worldwide.

NCT Number	NCT05368974
Lead Sponsor	The Task Force for Global Health Collaborators: Centers for Disease Control and Prevention
Conditions	Hepatitis C
Enrollment	100 participants
Start Date	2022-02-11
Primary Completion	2026-06-30 (estimated)
Study Completion	2026-12-30 (estimated)
Updated on ClinicalTrials.gov	2024-12-18