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Tests treatment safety and results for Hepatitis C
Official title Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV
ClinicalTrials.gov ID: NCT07040319
What this study is testing
What is Glecaprevir/pibrentasvir?
Glecaprevir/pibrentasvir is an investigational medicine, given as an once-daily, being studied as a potential treatment for hepatitis c.
Also referred to as GLE/PIB.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 45, women only
You may be able to join if
- Of legal age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with...
- 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...
- At screening and at study entry, no evidence of multiple gestation, fetal anomalies, or intrauterine fetal growth restriction, as determined by the...
You likely can't join if
- 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...
- Shortened cervix less than 20 mm if noted on ultrasound during the current pregnancy, as determined by the site investigator based on available...
- Receipt of any prohibited medication, within 14 days prior to entry, as determined by the site investigator based on pregnant participant report and...
- Any of the following liver-related conditions:
See the full eligibility criteria
- 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...
- 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
- 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...
- 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...
- 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:
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Aurora, Colorado, United States
- Jacksonville, Florida, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Stony Brook, New York, United States
- The Bronx, New York, United States
- Houston, Texas, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 16 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Aurora, Colorado, United States; Jacksonville, Florida, United States; Chicago, Illinois, United States; Baltimore, Maryland, United States; Stony Brook, New York, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.