Feasibility and Acceptability of HCV Treatment in Pregnancy

Recruiting

• Conditions: Hepatitis C; Pregnancy Complications
• Interventions: Drug: Glecaprevir-pibrentasvir

• Registration Number: NCT06367465
• Lead Sponsor: Washington University School of Medicine

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:
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Detailed Description

Pregnant adults over the age of 18 with a history of either past or current drug use 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 consent to participate in the study will be treated with glecaprevir-pibrentasvir.
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-02-01
• Study First Submitted: 2024-03-06
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-11
• Last Update Submitted: 2024-04-11
• Study First Posted: 2024-04-16
• Last Update Posted: 2024-04-16
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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.

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Female patients ≥ 18 years old, pregnant at the time of study intake, diagnosed with hepatitis c	Glecaprevir-pibrentasvir	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 Measures

Name	Time	Method
Medication adherence and treatment completion rates.	2 years	The primary objective of this study is to assess patient adherence and treatment completion rates of women with a history of past or current drug use who receive initiation of Hepatitis C Virus treatment with glecaprevir-pibrentasvir during pregnancy. The primary objective of this study is to assess patient adherence and treatment completion rates of women w...

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction Questionnaire	2 years	To assess patient satisfaction with early initiation of glecaprevir-pibrentasvir during pregnancy.
Virologic outcome and clinical success at Day 28 post treatment	2 years	Virologic and clinical outcomes at 4 weeks after completion of glecaprevir-pibrentasvir between patients who received glecaprevir-pibrentasvir during pregnancy and to those who received it post-partum.
Sample size estimation for future study	2 years	Sample size estimation for future study

Trial Locations

Locations (2)

Barnes Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States

Washington Univeristy; 🇺🇸 Saint Louis, Missouri, United States