AzTrials
AzTrials

Hepatitis CPhase 1/2NCT07040319

Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV

A Phase 1/2 study testing Glecaprevir/pibrentasvir in people with Hepatitis C, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a Phase I/II, multi-site, open-label, single arm study to describe the pharmacokinetics (PK) and safety of glecaprevir/pibrentasvir (GLE/PIB) initiated during pregnancy in women with hepatitis C virus (HCV) infection (acute or chronic) with or without HIV and to evaluate safety for their infants through 10… Read more about this study

Who is it for?
Ages 16 to 45 years, women only
Conditions the study is for
Hepatitis C
What is being tested?
Glecaprevir/pibrentasvir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
10 sitesUnited States
Study dates
25 Jun 2026to 3 Mar 2028
Phase
Phase 1/2
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 16 to 45 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Of legal age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with institutional review board/ethics committee (IRB/EC) policies and procedures
  • Willing and able to provide written informed consent for their own and their infant's study participation
  • At entry, 16-45 years of age (inclusive)
  • At entry, gestational age of 14-32 weeks, defined as greater than 13 weeks plus six days and less than or equal to 32 completed weeks gestation, as determined by the site investigator based on best obstetric estimate
  • At screening and at study entry, no evidence of multiple gestation, fetal anomalies, or intrauterine fetal growth restriction, as determined by the site investigator based on ultrasound
  • At screening, detectable HCV RNA test result based on testing of a specimen collected within 30 days prior to entry
Show all 20Show fewer
  • At screening, negative test results for hepatitis B surface antigen based on testing of a specimen collected within 30 days prior to entry
  • At screening (i.e., from specimens collected within 30 days prior to entry), has normal, grade 1, grade 2, or grade 3 results for the following
  • Aspartate aminotransferase (AST) (<10.0 x ULN)
  • Alanine aminotransferase (ALT) (<10.0 x ULN)
  • At screening (i.e., from specimens collected within 30 days prior to entry), has normal, grade 1, or grade 2 results for the following
  • Hemoglobin (≥8.5 g/dL)
  • Creatinine (≤1.8 x ULN)
  • At screening (i.e., from specimens collected within 30 days prior to entry), has normal or grade 1 results for the following
  • International normalized ratio (INR) (<1.5 x ULN)
  • Platelet count (≥100,000 cells/mm3)
  • Total bilirubin (<1.6 x ULN)
  • HIV status determined based on testing meeting the requirements specified in protocol
  • For pregnant participants living with HIV: has a suppressed HIV viral load (HIV-1 RNA below the limit of quantification of the assay) on an ARV regimen for at least 30 consecutive days prior to entry that does not include efavirenz, etravirine, cobicistat, or any protease inhibitor (e.g., atazanavir, darunavir, lopinavir, ritonavir), as determined by the site investigator based on available medical records
  • At entry, expects to remain in the geographic area of the study site during pregnancy and for 10 weeks postpartum (or for 20 weeks post-entry, depending on gestational age at entry), as determined by the site investigator based on pregnant participant report

Who cannot join

  • Any previous treatment for hepatitis C, including HCV DAAs or interferon-based treatment
  • High risk of preterm delivery, defined as either of the following:
  • History of spontaneous preterm delivery at less than 34 weeks, as determined by the site investigator based on pregnant participant report and available medical records, or
  • Shortened cervix less than 20 mm if noted on ultrasound during the current pregnancy, as determined by the site investigator based on available medical records
  • Receipt of any prohibited medication, within 14 days prior to entry, as determined by the site investigator based on pregnant participant report and available medical records
  • Any of the following liver-related conditions:
Show all 9Show fewer
  • Clinical diagnosis of acute hepatitis not otherwise attributable to hepatitis C with AST or ALT ≥2.5 x ULN
  • Evidence of decompensated cirrhosis including history of or present variceal hemorrhage, ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatocellular carcinoma, hepatorenal syndrome, or hepatopulmonary syndrome
  • Has any other documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

IMPAACT ClinicalTrials.gov Coordinator contact

impaact.ctgov@fstrf.org

Katie McCarthy contact

919-321-3326

kmccarthy@fhi360.org

10 sites in 1 country

United States10 sites, 10 recruiting

  • University of Colorado Denver

    Aurora, Colorado, 80045

    Carrie Chambers, RN, 720-777-4424, carrie.chambers@childrenscolorado.org

    Recruiting

  • Johns Hopkins University Baltimore

    Baltimore, Maryland, 21287

    Amanda Haines, BSN, RN, 443-287-8888, ahaines8@jhmi.edu

    Recruiting

  • Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60614

    Rasima Cehic, RN, 312-227-8273, rcehic@luriechildrens..org

    Recruiting

  • Baylor College of Medicine//Texas Children's Hospital

    Houston, Texas, 77030

    Mariam Pontifes, 832-822-1268, mepontif@texaschildrens.org

    Recruiting

  • Univ. of Florida Jacksonville

    Jacksonville, Florida, 32209

    Adnan Shabbir, 904-244-3796, adnan.shabbir@jax.ufl.edu

    Recruiting

  • USC LA

    Los Angeles, California, 90089

    Yvonne Morales, LVN, 323-865-1561, ytr@usc.edu

    Recruiting

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90095

    Misciel Macaraig, BA, CCRC, 310-206-6369, mbmacaraig@mednet.ucla.edu

    Not yet recruiting

  • SUNY Stony Brook

    Stony Brook, New York, 11794

    Barsha Chakraborty, MPH, 631-444-8225, barsha.chakraborty@stonybrookmedicine.edu

    Recruiting

  • Bronx-Lebanon Hospital Center

    The Bronx, New York, 10457

    Martha Cavallo, PNP, 718-960-1016, mcavallo@bronxcare.org

    Recruiting

  • Jacobi Medical Center

    The Bronx, New York, 10461

    Marlene Burey, RN, PNP, 718-918-4783, marlene.burey@nychhc.org

    Not yet recruiting

Other trials in United States

About this study

Official title: Phase I/II Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV

This is a Phase I/II, multi-site, open-label, single arm study to describe the pharmacokinetics (PK) and safety of glecaprevir/pibrentasvir (GLE/PIB) initiated during pregnancy in women with hepatitis C virus (HCV) infection (acute or chronic) with or without HIV and to evaluate safety for their infants through 10 weeks postpartum.

Conditions
Hepatitis C
Being tested
Glecaprevir/pibrentasvir
Keywords
HIV, Hepatitis C, Pregnancy, Glecaprevir/Pibrentasvir
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Glecaprevir/pibrentasvirDrug

    Also called GLE/PIB

    100 mg glecaprevir and 40 mg pibrentasvir for a total daily dose of glecaprevir 300 mg/pibrentasvir 120 mg

Study groups in NCT07040319
Study groupRoleWhat they receive
GLE/PIBExperimentalPregnant participants will take three (3) GLE/PIB fixed-dose combination tablets orally once daily with food for eight weeks
Receives: Drug: Glecaprevir/pibrentasvir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Geometric mean AUC0-24h

    Area under the curve from start of dose to 24 hours post dose

    Measured: At weeks 3 & 6

  2. Geometric mean Cmax

    Peak concentration from start of dose to 24 hours post dose

    Measured: At weeks 3 & 6

  3. Geometric mean C24h

    Concentration at 24 hours post dose

    Measured: At weeks 3 & 6

  4. Percentage of pregnant/ postpartum participants who experience a grade 3 or higher adverse event assessed as related to study drug

    Measured: Initiation of treatment to a) completion of treatment and b) latter of 10 weeks post-partum or 20 weeks post treatment initiation

  5. Percentage of pregnant participants who experience a serious adverse event assessed as related to study drug

    Measured: Initiation of treatment to a) completion of treatment and b) latter of 10 weeks post-partum or 20 weeks post treatment initiation

Secondary outcomes (16)

  1. Percentage of pregnant/postpartum participants with sustained virologic response (SVR12)

    defined as unquantifiable hepatitis C RNA (less than the lower limit of quantification [<LLOQ])

    Measured: 12 weeks after planned treatment completion

  2. Percentage of pregnant participants with spontaneous abortions or miscarriage

    (<20 weeks gestation)

    Measured: At birth/delivery

  3. Percentage of pregnant participants with stillbirths

    (≥20 weeks gestation)

    Measured: At birth/delivery

  4. Percentage of infants small for gestational age

    <10th percentile

    Measured: At birth/delivery

  5. Percentage of infants with low birth weight

    <2500 g

    Measured: At birth/delivery

  6. Percentage of pre-term births

    <37 weeks gestation

    Measured: At birth/delivery

  7. Percentage of pregnancies with occurrence of any of the following adverse pregnancy events

    spontaneous abortion or miscarriage, stillbirth, small gestational age, low birth weight, or preterm birth

    Measured: At birth/delivery

  8. Percentage of infants with a congenital abnormality

    Measured: At birth/delivery

  9. Percentage of infants with a grade 5 adverse event

    Measured: From birth through 10 weeks of age

  10. Percentage of infants with Grade 3 or higher adverse event assessed as related to study drug

    Measured: From birth through 10 weeks of age

  11. Percentage of infants with a serious adverse events assessed as related to study drug

    Measured: From birth through 10 weeks of age

  12. Percentage of occurrence of any of the following in infants: grade 5 adverse event within 28 days of birth, grade 3 or higher adverse event assessed as related to study drug, or severe adverse event assessed as related to study drug

    Measured: From birth through 10 weeks of age

  13. Median weight of infants

    Measured: At birth and 10 weeks of age

  14. Median length of infants

    Measured: At birth and 10 weeks of age

  15. Median head circumference of infants

    Measured: At birth and 10 weeks of age

  16. Percentage of infants with quantifiable hepatitis C RNA

    Measured: At 10 or more weeks of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2025
  2. Study start25 Jun 2026
  3. Primary completion3 Mar 2028 (estimated)
  4. Study completion3 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07040319
Sponsor's protocol ID
IMPAACT 2041
Status last verified
Aug 2026
First submitted
13 Jun 2025
Last updated
14 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Glecaprevir/pibrentasvir in people with Hepatitis C, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 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 20 inclusion and 9 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 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 IMPAACT ClinicalTrials.gov Coordinator (impaact.ctgov@fstrf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric mean AUC0-24h (time frame: At weeks 3 & 6). The study lists 5 primary outcomes in all. 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 NCT07040319.

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 14 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in