Recruiting

HCV Treatment

Sponsor:

Washington University School of Medicine

Code:

NCT06367465

Conditions

Hepatitis C

Pregnancy Complications

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Glecaprevir-pibrentasvir

Study Details

Brief summary:

Pregnant adults over the age of 18 who are seen in the Washington University obstetrics and gynecology, maternal fetal medicine or infectious diseases clinic or admitted to BJH with hepatitis C virus infection who have a history of past or current drug use

Participant Duration: Approximately 1 year.

Aims:

Aim 1 - Evaluate adherence and treatment completion rates when glecaprevir-pibrentasvir is started during pregnancy for women who use drugs.

Aim 2 - Evaluate patient experience with hepatitis C virus treatment during pregnancy.

Conditions

Hepatitis C

Pregnancy Complications

Study ID

NCT06367465

Start date

Feb 1, 2024

Status verified date

Jun, 2026

Completion date

Dec 28, 2026

Anticipated

Primary completion date

Dec 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Female patients ≥ 18 years old, pregnant at the time of study intake, diagnosed with hepatitis c virus infection and a history of past or current drug use.

Exclusion Criteria:

\-

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Female patients ≥ 18 years old, pregnant at the time of study intake, diagnosed with hepatitis c

Female patients ≥ 18 years old, pregnant at the time of study intake, diagnosed with hepatitis c virus infection and a history of past or current drug use.

Interventions

Glecaprevir-pibrentasvir

Glecaprevir-pibrentasvir 100 mg / 40 mg 3 tab orally (PO) once daily for 56 days.

Primary outcome measure

  • Medication adherence and treatment completion rates. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Tracey Bach, MBA

314-273-6075habrockt@wustl.edu

Laura Marks, MD, PhD

marks@wustl.edu

Locations

Barnes Jewish Hospital

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Tracey Bach

314-273-6075habrockt@wustl.edu

Principal Investigator:

Laura Marks, MD, PhD

Washington Univeristy

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Laura Marks, MD,PhD

marks@wustl.edu

Tracey Habrock-Bach, MBA

314-273-6075habrockt@wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-06-09.