Hepatitis CNCT06367465
Feasibility and Acceptability of HCV Treatment in Pregnancy
An observational study of Hepatitis C and Pregnancy Complications, run by Washington University School of Medicine at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hepatitis C, Pregnancy Complications
- What is being tested?
- Glecaprevir-pibrentasvir
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2024to 28 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Laura Marks, MD, PhD contact
United States2 sites, 2 recruiting
- Recruiting
Barnes Jewish Hospital
St Louis, Missouri, 63110
Tracey Bach, 314-273-6075, habrockt@wustl.edu
Laura Marks, MD, PhD
- Recruiting
Washington Univeristy
St Louis, Missouri, 63110
Laura Marks, MD,PhD, marks@wustl.edu
Tracey Habrock-Bach, MBA, 314-273-6075, habrockt@wustl.edu
About this study
Official title: Feasibility and Acceptability of Early Linkage to HCV Treatment in Pregnancy Feasibility and Acceptability of Early Linkage to HCV Treatment in Pregnancy
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.
Read the 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.
- Conditions
- Hepatitis C, Pregnancy Complications
- Being tested
- Glecaprevir-pibrentasvir
- Medical subject headings
- Hepatitis C, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glecaprevir-pibrentasvirDrug
Glecaprevir-pibrentasvir 100 mg / 40 mg 3 tab orally (PO) once daily for 56 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Glecaprevir-pibrentasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
Patient satisfaction Questionnaire
To assess patient satisfaction with early initiation of glecaprevir-pibrentasvir during pregnancy.
Measured: 2 years
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.
Measured: 2 years
Sample size estimation for future study
Sample size estimation for future study
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Feb 2024
- Primary completion28 Dec 2026 (estimated)
- Study completion28 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367465
- Sponsor's protocol ID
- 202308056
- Status last verified
- Jun 2026
- First submitted
- 6 Mar 2024
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rossi RM, Wolfe C, Brokamp R, McAllister JM, Wexelblatt S, Warshak CR, Hall ES. Reported Prevalence of Maternal Hepatitis C Virus Infection in the United States. Obstet Gynecol. 2020 Feb;135(2):387-395. doi: 10.1097/AOG.0000000000003644.
PubMed 31923064ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633.
PubMed 29683911Bryant AS, Haas JS, McElrath TF, McCormick MC. Predictors of compliance with the postpartum visit among women living in healthy start project areas. Matern Child Health J. 2006 Nov;10(6):511-6. doi: 10.1007/s10995-006-0128-5.
PubMed 16807794Wilcox A, Levi EE, Garrett JM. Predictors of Non-Attendance to the Postpartum Follow-up Visit. Matern Child Health J. 2016 Nov;20(Suppl 1):22-27. doi: 10.1007/s10995-016-2184-9.
PubMed 27562797Weir S, Posner HE, Zhang J, Willis G, Baxter JD, Clark RE. Predictors of prenatal and postpartum care adequacy in a medicaid managed care population. Womens Health Issues. 2011 Jul-Aug;21(4):277-85. doi: 10.1016/j.whi.2011.03.001. Epub 2011 May 12.
PubMed 21565526Bushman ET, Subramani L, Sanjanwala A, Dionne-Odom J, Franco R, Owen J, Subramaniam A. Pragmatic Experience with Risk-based versus Universal Hepatitis C Screening in Pregnancy: Detection of Infection and Postpartum Linkage to Care. Am J Perinatol. 2021 Sep;38(11):1109-1116. doi: 10.1055/s-0041-1728827. Epub 2021 May 2.
PubMed 33934324Jarlenski M, Chen Q, Ahrens KA, Allen L, Austin AE, Chappell C, Donohue JM, Hammerslag L, Lanier P, McDuffie MJ, Talbert J, Tang L, Krans EE; Medicaid Outcomes Distributed Research Network (MODRN). Postpartum Follow-up Care for Pregnant Persons With Opioid Use Disorder and Hepatitis C Virus Infection. Obstet Gynecol. 2022 May 1;139(5):916-918. doi: 10.1097/AOG.0000000000004760. Epub 2022 Apr 5.
PubMed 35576352Epstein RL, Sabharwal V, Wachman EM, Saia KA, Vellozzi C, Hariri S, Linas BP. Perinatal Transmission of Hepatitis C Virus: Defining the Cascade of Care. J Pediatr. 2018 Dec;203:34-40.e1. doi: 10.1016/j.jpeds.2018.07.006. Epub 2018 Aug 28.
PubMed 30170857Kushner T, Lange M, Sperling R, Dieterich D. Treatment of Women With Hepatitis C Diagnosed in Pregnancy: a Co-Located Treatment Approach. Gastroenterology. 2022 Nov;163(5):1454-1456.e1. doi: 10.1053/j.gastro.2022.07.017. Epub 2022 Jul 18. No abstract available.
PubMed 35863531Zeng QL, Yu ZJ, Lv J, Zhang HX, Wang B, Dong XP, Chen ZM, Cui GL, Ji F. Sofosbuvir-based therapy for late pregnant women and infants with severe chronic hepatitis C: A case series study. J Med Virol. 2022 Sep;94(9):4548-4553. doi: 10.1002/jmv.27877. Epub 2022 Jun 1.
PubMed 35595682AbdAllah M, Alboraie M, Abdel-Razek W, Hassany M, Ammar I, Kamal E, Alalfy M, Okasha A, El Akel W, Shaaban E, Elbaz T, Hefny Z, Gomaa A, El-Bendary M, El-Serafy M, Esmat G, Doss W, El-Sayed MH. Pregnancy outcome of anti-HCV direct-acting antivirals: Real-life data from an Egyptian cohort. Liver Int. 2021 Jul;41(7):1494-1497. doi: 10.1111/liv.14913. Epub 2021 May 11.
PubMed 33905164Chappell CA, Scarsi KK, Kirby BJ, Suri V, Gaggar A, Bogen DL, Macio IS, Meyn LA, Bunge KE, Krans EE, Hillier SL. Ledipasvir plus sofosbuvir in pregnant women with hepatitis C virus infection: a phase 1 pharmacokinetic study. Lancet Microbe. 2020 Sep;1(5):e200-e208. doi: 10.1016/S2666-5247(20)30062-8. Epub 2020 Jul 27.
PubMed 32939459Bhattacharya D, Aronsohn A, Price J, Lo Re V; AASLD-IDSA HCV Guidance Panel. Hepatitis C Guidance 2023 Update: AASLD-IDSA Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection. Clin Infect Dis. 2023 May 25:ciad319. doi: 10.1093/cid/ciad319. Online ahead of print.
PubMed 37229695
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Early Linkage to HCV Treatment in Pregnancy Feasibility and Acceptability of Early Linkage to HCV Treatment in Pregnancy
- ClinicalTrials.gov ID
- NCT06367465
- Acronym / sponsor ID
- 202308056
- Conditions
- Hepatitis C, Pregnancy Complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 28 Dec 2026 (estimated)
- Study completion
- 28 Dec 2026 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female patients ≥ 18 years old, pregnant at the time of study intake, diagnosed with hepatitis c | – | Drug: Glecaprevir-pibrentasvirFemale 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glecaprevir-pibrentasvirGlecaprevir-pibrentasvir 100 mg / 40 mg 3 tab orally (PO) once daily for 56 days. | Drug | Female patients ≥ 18 years old, pregnant at the time of study intake, diagnosed with hepatitis c |
Primary outcome
Medication adherence and treatment completion rates.
Time frame: 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 with a history of past or current drug use who receive initiation of Hepatitis C Virus treatment with glecaprevir-pibrentasvir during pregnancy.
3 secondary outcomes
Patient satisfaction Questionnaire
Time frame: 2 years
Virologic outcome and clinical success at Day 28 post treatment
Time frame: 2 years
Sample size estimation for future study
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Background: PubMed 31923064Rossi RM, Wolfe C, Brokamp R, McAllister JM, Wexelblatt S, Warshak CR, Hall ES. Reported Prevalence of Maternal Hepatitis C Virus Infection in the United States. Obstet Gynecol. 2020 Feb;135(2):387-395. doi: 10.1097/AOG.0000000000003644.
- Background: PubMed 29683911ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633.
- Background: PubMed 16807794Bryant AS, Haas JS, McElrath TF, McCormick MC. Predictors of compliance with the postpartum visit among women living in healthy start project areas. Matern Child Health J. 2006 Nov;10(6):511-6. doi: 10.1007/s10995-006-0128-5.
- Background: PubMed 27562797Wilcox A, Levi EE, Garrett JM. Predictors of Non-Attendance to the Postpartum Follow-up Visit. Matern Child Health J. 2016 Nov;20(Suppl 1):22-27. doi: 10.1007/s10995-016-2184-9.
- Background: PubMed 21565526Weir S, Posner HE, Zhang J, Willis G, Baxter JD, Clark RE. Predictors of prenatal and postpartum care adequacy in a medicaid managed care population. Womens Health Issues. 2011 Jul-Aug;21(4):277-85. doi: 10.1016/j.whi.2011.03.001. Epub 2011 May 12.
- Background: PubMed 33934324Bushman ET, Subramani L, Sanjanwala A, Dionne-Odom J, Franco R, Owen J, Subramaniam A. Pragmatic Experience with Risk-based versus Universal Hepatitis C Screening in Pregnancy: Detection of Infection and Postpartum Linkage to Care. Am J Perinatol. 2021 Sep;38(11):1109-1116. doi: 10.1055/s-0041-1728827. Epub 2021 May 2.
- Background: PubMed 35576352Jarlenski M, Chen Q, Ahrens KA, Allen L, Austin AE, Chappell C, Donohue JM, Hammerslag L, Lanier P, McDuffie MJ, Talbert J, Tang L, Krans EE; Medicaid Outcomes Distributed Research Network (MODRN). Postpartum Follow-up Care for Pregnant Persons With Opioid Use Disorder and Hepatitis C Virus Infection. Obstet Gynecol. 2022 May 1;139(5):916-918. doi: 10.1097/AOG.0000000000004760. Epub 2022 Apr 5.
- Background: PubMed 30170857Epstein RL, Sabharwal V, Wachman EM, Saia KA, Vellozzi C, Hariri S, Linas BP. Perinatal Transmission of Hepatitis C Virus: Defining the Cascade of Care. J Pediatr. 2018 Dec;203:34-40.e1. doi: 10.1016/j.jpeds.2018.07.006. Epub 2018 Aug 28.
- Background: PubMed 35863531Kushner T, Lange M, Sperling R, Dieterich D. Treatment of Women With Hepatitis C Diagnosed in Pregnancy: a Co-Located Treatment Approach. Gastroenterology. 2022 Nov;163(5):1454-1456.e1. doi: 10.1053/j.gastro.2022.07.017. Epub 2022 Jul 18. No abstract available.
- Background: PubMed 35595682Zeng QL, Yu ZJ, Lv J, Zhang HX, Wang B, Dong XP, Chen ZM, Cui GL, Ji F. Sofosbuvir-based therapy for late pregnant women and infants with severe chronic hepatitis C: A case series study. J Med Virol. 2022 Sep;94(9):4548-4553. doi: 10.1002/jmv.27877. Epub 2022 Jun 1.
- Background: PubMed 33905164AbdAllah M, Alboraie M, Abdel-Razek W, Hassany M, Ammar I, Kamal E, Alalfy M, Okasha A, El Akel W, Shaaban E, Elbaz T, Hefny Z, Gomaa A, El-Bendary M, El-Serafy M, Esmat G, Doss W, El-Sayed MH. Pregnancy outcome of anti-HCV direct-acting antivirals: Real-life data from an Egyptian cohort. Liver Int. 2021 Jul;41(7):1494-1497. doi: 10.1111/liv.14913. Epub 2021 May 11.
- Background: PubMed 32939459Chappell CA, Scarsi KK, Kirby BJ, Suri V, Gaggar A, Bogen DL, Macio IS, Meyn LA, Bunge KE, Krans EE, Hillier SL. Ledipasvir plus sofosbuvir in pregnant women with hepatitis C virus infection: a phase 1 pharmacokinetic study. Lancet Microbe. 2020 Sep;1(5):e200-e208. doi: 10.1016/S2666-5247(20)30062-8. Epub 2020 Jul 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Marks, MD, PhD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C and Pregnancy Complications, run by Washington University School of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tracey Bach, MBA (314-273-6075, habrockt@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence and treatment completion rates. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06367465, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.