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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: Recruiting study of Hepatitis C, sponsored by The Task Force for Global Health.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Direct Acting Antivirals
Study Locations (1)
Georgia
- The Taskforce for Global Health - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-02-11 |
| Est. Completion | 2026-12-30 |
What NCT05368974 shows while recruiting
NCT05368974 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,889-participant average among 106 other Hepatitis C trials with a reported enrollment target (95% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Hepatitis C
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05368974's enrollment target sits among peer trials
100 56th of 106 higher than 49 of 106 other Hepatitis C trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatitis C trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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