Registry for treating hepatitis C in pregnant women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.