Actively Recruiting
The Treatment in Pregnancy for Hepatitis C ("TiP-HepC") Registry
Led by The Task Force for Global Health · Updated on 2024-12-18
100
Participants Needed
1
Research Sites
254 weeks
Total Duration
On this page
Sponsors
T
The Task Force for Global Health
Lead Sponsor
C
Centers for Disease Control and Prevention
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The Treatment in Pregnancy for Hepatitis C ("TiP-HepC") Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented pregnancy with estimated date of conception by last menstrual period or ultrasound, and actual date of delivery
- Documented chronic hepatitis C infection before or during pregnancy confirmed by HCV RNA or core antigen test
- Exposure to direct-acting antiviral medications within 30 days of conception and before pregnancy outcome
You will not qualify if you...
- Use of direct-acting antiviral treatments that include ribavirin or interferon during pregnancy due to known harm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Taskforce for Global Health
Atlanta, Georgia, United States, 30030
Actively Recruiting
Research Team
N
Neil Gupta, MD
CONTACT
L
Lindsey Hiebert
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here