Viewing Study NCT06367465



Ignite Creation Date: 2024-05-06 @ 8:23 PM
Last Modification Date: 2024-10-26 @ 3:27 PM
Study NCT ID: NCT06367465
Status: RECRUITING
Last Update Posted: 2024-04-16
First Post: 2024-03-06

Brief Title: Feasibility and Acceptability of HCV Treatment in Pregnancy
Sponsor: Washington University School of Medicine
Organization: Washington University School of Medicine

Study Overview

Official Title: Feasibility and Acceptability of Early Linkage to HCV Treatment in Pregnancy Feasibility and Acceptability of Early Linkage to HCV Treatment in Pregnancy
Status: RECRUITING
Status Verified Date: 2024-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
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

All consented individuals will participate in four 4 in-person study visits At the first in-person study visit patients will receive information about hepatitis C virus treatment complete testing for HIV and HBV and be assessed for cirrhosis Patients who meet study criteria will initiate HCV treatment with glecaprevir-pibrentasvir Patients will return for a second in-person study visit while on HCV treatment between day 14-56 at which time they will complete a questionnaire about medication adherence and have HCV RNA testing performed A third in-person study visit will occur at completion of HCV treatment at which time patients will again complete a questionnaire about medication adherence and have HCV RNA testing performed The final study visit will occur 4 weeks after completion of HCV treatment at which time patients will have HCV RNA testing performed All labs that are included as part of the study are standard of care labs for all pregnant women and are standard of care during HCV treatment HCV RNA CBC and CMP

Additional information about the clinical course of infection including HCV RNA testing obtained at the time of labor and delivery and maternal and fetal outcomes will be abstracted from the medical record at 1 year post study enrollment

All participants will be followed longitudinally in the medical record to ascertain maternal and fetal outcomes and HCV re-infections for up to 1 year post study enrollment

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None