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

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT07040319
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
16 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Glecaprevir/pibrentasvir — DRUG
    100 mg glecaprevir and 40 mg pibrentasvir for a total daily dose of glecaprevir 300 mg/pibrentasvir 120 mg

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Oct 30, 2027
Completion
Oct 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: GLE/PIB
    Pregnant participants will take three (3) GLE/PIB fixed-dose combination tablets orally once daily with food for eight weeks

Primary Outcome Measure

Geometric mean AUC0-24h [ Time Frame: At weeks 3 & 6 ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
David Geffen School of Medicine at UCLALos AngelesCalifornia90095
Misciel Macaraig, BA, CCRC
[email protected]
310-206-6369
USC LALos AngelesCalifornia90089
Yvonne Morales, LVN
[email protected]
323-865-1561
University of Colorado DenverAuroraColorado80045
Carrie Chambers, RN
[email protected]
720-777-4424
Univ. of Florida JacksonvilleJacksonvilleFlorida32209
Adnan Shabbir
[email protected]
904-244-3796
Lurie Children's Hospital of ChicagoChicagoIllinois60614
Rasima Cehic, RN
[email protected]
312-227-8273
Johns Hopkins University BaltimoreBaltimoreMaryland21287
Amanda Haines, BSN, RN
[email protected]
443-287-8888
SUNY Stony BrookStony BrookNew York11794
Barsha Chakraborty, MPH
[email protected]
631-444-8225
Bronx-Lebanon Hospital CenterThe BronxNew York10457
Martha Cavallo, PNP
[email protected]
718-960-1016
Jacobi Medical CenterThe BronxNew York10461
Marlene Burey, RN, PNP
[email protected]
718-918-4783
Baylor College of Medicine//Texas Children's HospitalHoustonTexas77030
Mariam Pontifes
[email protected]
832-822-1268

Find similar trials in Los Angeles, CA

By research site
David Geffen School of Medicine at UCLA· Los Angeles, CAUSC LA· Los Angeles, CAUniversity of Colorado Denver· Aurora, COUniv. of Florida Jacksonville· Jacksonville, FLLurie Children's Hospital of Chicago· Chicago, ILJohns Hopkins University Baltimore· Baltimore, MD

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