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NCT05368974 · ClinicalTrials.gov registry record

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

A clinical trial of Hepatitis C, sponsored by The Task Force for Global Health.

Recruiting
Registry status
100
Enrollment target
1
Study location

NCT05368974 is a study of Hepatitis C that is actively recruiting participants, run by The Task Force for Global Health. The registered enrollment target is 100 participants, below the 1,889-participant average among 106 other Hepatitis C trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05368974, a study of Hepatitis C, is actively recruiting participants, sponsored by The Task Force for Global Health.

RECRUITING
Registry status
100 participants
Enrollment target
1
Study location

Study 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 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.

Conditions Studied

Interventions

  • DRUG Direct Acting Antivirals

Study Locations (1)

Georgia

  • The Taskforce for Global Health - Atlanta

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2022-02-11
Est. Completion 2026-12-30

Sponsor

The Task Force for Global Health

1 total trials

What the Registry Record Tells You About NCT05368974

The ClinicalTrials.gov registry entry for NCT05368974 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,889-participant average among 106 other Hepatitis C trials with a reported enrollment target (95% lower). The listed sponsor is The Task Force for Global Health, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hepatitis C appearing as the primary indexed condition, and to 1 intervention - of which Direct Acting Antivirals is the first listed.

NCT05368974 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.

Frequently Asked Questions

What is clinical trial NCT05368974 about?

NCT05368974 is a clinical study titled "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 regardi...

What is the current status of trial NCT05368974?

This trial is currently recruiting. The enrollment target is 100 participants. The study started on 2022-02-11. Estimated completion is 2026-12-30.

What conditions does trial NCT05368974 study?

This clinical trial studies the following conditions: Hepatitis C.

What interventions are being tested in trial NCT05368974?

The interventions under investigation include: Direct Acting Antivirals (DRUG).

Who is sponsoring clinical trial NCT05368974?

This trial is sponsored by The Task Force for Global Health, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05368974 being conducted?

This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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