Health TrialsbyHealthPanel

Feasibility and Acceptability of HCV Treatment in Pregnancy

ConditionsHepatitis CPregnancy Complications
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorWashington University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

Adults over the age of 18 with hepatitis C virus infection who are currently pregnant with a history of past or current drug use. Patients must have health insurance which covers hepatitis C virus treatment with direct acting antivirals and who agree to begin HCV treatment with glecaprevir-pibrentasvir during pregnancy. Participants pregnancies must have reached at least 10 weeks gestational age prior to initiation of medication. Adults over the age of 18 with hepatitis C virus infection who are currently pregnant with a history of past or current drug use. Patients must have health insurance which covers hepatitis C virus treatment with direct acting antivirals and who agree to begin HCV treatment with glecaprevir-pibrentasvir during pregnancy. Participants pregnancies must have reached at least 10 weeks gestational age prior to initiation of medication.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Glecaprevir-pibrentasvir

    Drug

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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Female patients ≥ 18 years old, pregnant at the time of study intake, diagnosed with hepatitis c1 intervention

Trial outcomes

Primary outcomes

1

Medication adherence and treatment completion rates.

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 with a history of past or current drug use who receive initiation of Hepatitis C Virus treatment with glecaprevir-pibrentasvir during pregnancy.

Time frame
2 years

Secondary outcomes

1

Patient satisfaction Questionnaire

To assess patient satisfaction with early initiation of glecaprevir-pibrentasvir during pregnancy.

Time frame
2 years
2

Virologic outcome and clinical success at Day 28 post treatment

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.

Time frame
2 years
3

Sample size estimation for future study

Sample size estimation for future study

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

Source ClinicalTrials.gov
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