Recruiting

TiP-HepC

Sponsor:

The Task Force for Global Health

Code:

NCT05368974

Conditions

Hepatitis C

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Direct Acting Antivirals

Study Details

Brief 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.

Conditions

Hepatitis C

Study ID

NCT05368974

Start date

Feb 11, 2022

Status verified date

Dec, 2024

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Interventions

Direct Acting Antivirals

Direct-acting antiviral exposure during documented pregnancy

Primary outcome measure

  • Number of adverse pregnancy outcomes [ Time Frame: 1 year ]
  • Number of adverse birth outcomes [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Neil Gupta, MD

4043014134ngupta-consultant@taskforce.org

Lindsey Hiebert

4043014134lhiebert@taskforce.org

Locations

The Taskforce for Global Health

Recruiting

Atlanta, Georgia, United States, 30030

Contacts

Lindsey Hiebert

4043014134lhiebert@taskforce.org

More Information

Sponsor

The Task Force for Global Health

Last update posted

Dec 18, 2024

Last verified

Dec, 2024

Keywords

  • pregnancy
  • hepatitis C

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Task Force for Global Health on 2024-12-18.