Feasibility and Acceptability of HCV Treatment in Pregnancy

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06367465
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 1, 2024
Status verified
Jun 2026
Primary completion
Dec 28, 2026
Completion
Dec 28, 2026

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Barnes Jewish HospitalSt LouisMissouri63110
Tracey Bach
[email protected]
314-273-6075
Laura Marks, MD, PhD (PRINCIPAL_INVESTIGATOR)
Washington UniveristySt LouisMissouri63110
Laura Marks, MD,PhD
[email protected]
Tracey Habrock-Bach, MBA
[email protected]
314-273-6075

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