Glecaprevir/Pibrentasvir for Hepatitis C

Recruiting at 9 trial locations

Overseen By Katie McCarthy

Age: < 65

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Efavirenz, Etravirine, Cobicistat, others

Disqualifiers: Hepatitis B, Decompensated cirrhosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 16-45 with hepatitis C, at 14-32 weeks gestation. It's open to those with or without HIV but requires a suppressed HIV viral load if positive. Participants must not have liver complications unrelated to hepatitis C, previous HCV treatment, high preterm delivery risk, or other conditions that could affect the study.

Inclusion Criteria

I am legally able to give my own consent for treatment.

HIV status determined based on protocol requirements

I am between 14 and 32 weeks pregnant.

Exclusion Criteria

I do not have acute hepatitis or severe liver damage not caused by hepatitis C.

I have been treated for hepatitis C before.

High risk of preterm delivery

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Pregnant participants take three GLE/PIB fixed-dose combination tablets orally once daily with food

8 weeks

Follow-up

Participants and their infants are monitored for safety and effectiveness after treatment

10 weeks postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Glecaprevir/pibrentasvir

Trial Overview The study is examining Glecaprevir/Pibrentasvir (GLE/PIB) given during pregnancy to treat hepatitis C. It's a single-arm trial focusing on how the drug behaves in the body (pharmacokinetics) and its safety for both mother and infant until 10 weeks after birth.

How Is the Trial Designed?

Group I: GLE/PIB Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

AbbVie

Industry Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+