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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
The Task Force for Global Health
Study ID
NCT05368974
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Direct Acting Antivirals — DRUG
    Direct-acting antiviral exposure during documented pregnancy

Study Details

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.

Key Dates

Start date
Feb 11, 2022
Status verified
Dec 2024
Primary completion
Jun 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
100 participants (estimated)

Primary Outcome Measure

Number of adverse pregnancy outcomes [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Taskforce for Global HealthAtlantaGeorgia30030
Lindsey Hiebert
[email protected]
4043014134
John Ward, MD
Neil Gupta, MD

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The Taskforce for Global Health· Atlanta, GA

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