Registry for treating hepatitis C in pregnant women
An Observational Study of Mother-Infant Outcomes Following Antenatal Exposure to Direct-Acting Antivirals: the Treatment in Pregnancy for Hepatitis C ("TiP-HepC") Registry
This study is collecting information on pregnant women treated with new hepatitis C medications to see if they are safe for both mothers and their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | The Task Force for Global Health Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT05368974 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to collect data on mother-infant pairs exposed to direct-acting antiviral (DAA) medications during pregnancy to assess the safety and effectiveness of these treatments in reducing the risk of vertical transmission of hepatitis C virus (HCV). The study will gather information from healthcare providers and facilities worldwide to understand the outcomes of these exposures. Given the lack of approved treatments for HCV during pregnancy, this registry seeks to fill a critical gap in knowledge regarding the use of DAAs in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women with documented chronic hepatitis C infection who have been exposed to DAAs within 30 days of conception.
Not a fit: Patients who are not pregnant or those who have received contraindicated treatments such as ribavirin or interferon will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide crucial insights into safe treatment options for hepatitis C in pregnant women, potentially reducing mother-to-child transmission rates.
How similar studies have performed: While there is limited data on the use of DAAs in pregnant women, this approach is novel and aims to address a significant gap in current clinical practice.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: -Documented pregnancy with: Estimated date of conception by documentation of either 1) date of last menstrual period or 2) ultrasound evaluation Actual date of delivery * Documented chronic HCV infection prior to or during pregnancy (positive test for HCV RNA or HCV core antigen) * Documented DAA exposure occurring within 30 days of the estimated date of conception and before the pregnancy outcome (ie, fetal demise, spontaneous abortion, live delivery, etc). Eligible DAA drugs are listed in Appendix 1. Exclusion Criteria: \- DAA exposures that include ribavirin or interferon will be excluded given their established harm during pregnancy.
Where this trial is running
Atlanta, Georgia
- The Taskforce for Global Health — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: John Ward, MD — The Taskforce For Global Health
- Study coordinator: Neil Gupta, MD
- Email: ngupta-consultant@taskforce.org
- Phone: 4043014134
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.