The Treatment in Pregnancy for Hepatitis C (TiP-HepC) Registry - Trial NCT05368974
Access comprehensive clinical trial information for NCT05368974 through Pure Global AI's free database. This phase not specified trial is sponsored by The Task Force for Global Health and is currently Recruiting. The study focuses on Hepatitis C. Target enrollment is 100 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
Sponsor & Location
The Task Force for Global Health
Timeline & Enrollment
N/A
Feb 11, 2022
Jun 30, 2023
Primary Outcome
Number of adverse pregnancy outcomes,Number of adverse birth outcomes
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05368974
Non-Device Trial