Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV (NCT07040319)
Phase I/II Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: USC LA โ Los Angeles, California
Age range: 16 Years to 45 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (10 Sites)
- USC LA โ Los Angeles, California
- David Geffen School of Medicine at UCLA โ Los Angeles, California
- University of Colorado Denver โ Aurora, Colorado
- Univ. of Florida Jacksonville โ Jacksonville, Florida
- Lurie Children's Hospital of Chicago โ Chicago, Illinois
- Johns Hopkins University Baltimore โ Baltimore, Maryland
- SUNY Stony Brook โ Stony Brook, New York
- Bronx-Lebanon Hospital Center โ The Bronx, New York
- Jacobi Medical Center โ The Bronx, New York
- Baylor College of Medicine//Texas Children's Hospital โ Houston, Texas
๐ Contact the Study Coordinator
Phone: (323) 865-1561
Email: ytr@usc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Hepatitis C
- DBS TaT in Peer-assisted Telemedicine for Hepatitis C โ Portland, Oregon
- A Study to Evaluate Preemptive Therapy in Hepatitis C (HCV) Organ Transplant Recipients โ Phoenix, Arizona
- Advanced Care Coordination and Enhanced Linkage and Retention Among Transitional Re-Entrants โ Greenville, South Carolina
- ED Patient's Perceptions and Acceptability Toward a Novel POC HCV Viral Load Testing โ Baltimore, Maryland
- A Phase 1 Clinical Trial of Adjuvanted Protein-based HCV Vaccine Candidates (HCV Vaccine Trial) โ Edmonton, Alberta
- Use of a Patient-Centered Electronic App to Increase ED Patient's Knowledge on HCV to Improve the HCV Care Continuum โ Baltimore, Maryland
Explore by condition: All Hepatitis C clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.