Phase 2 Hepatitis C Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are old enough under local rules to give their own consent to take part in research
• People who are willing and able to sign a written consent form on behalf of themselves and their baby
• People who are between 16 and 45 years old at the time of joining
• People who are between 14 and 32 weeks pregnant at the time of joining, based on the best estimate from their care team
• People whose ultrasound shows no signs of twins or multiple babies, no baby abnormalities, and no problems with the baby's growth
• People whose blood test, taken within the 30 days before joining, shows that the hepatitis C virus (HCV) is detectable in their body
• People whose blood test, taken within the 30 days before joining, shows no signs of hepatitis B infection
• People whose liver enzyme levels (specific markers of liver health) are within an acceptable range on recent blood tests (confirm with trial site for exact values)
• People whose blood counts and kidney function fall within acceptable ranges on recent blood tests, including haemoglobin, creatinine, clotting ability, platelet count, and bilirubin (confirm with trial site for exact values)
• People whose HIV status has been confirmed through testing that meets the study's requirements
• People living with HIV who are pregnant and whose HIV virus levels are undetectable, and who have been on an HIV treatment regimen for at least 30 consecutive days before joining — the regimen must not include certain specific HIV medicines (efavirenz, etravirine, cobicistat, or protease inhibitors such as atazanavir, darunavir, lopinavir, or ritonavir)
• People who expect to stay in the area near the trial site throughout their pregnancy and for a period after the birth (the exact timeframe depends on how far along the pregnancy is at the time of joining)

Who may not be able to join:

• People who have previously received any treatment for hepatitis C, including newer direct-acting antiviral medicines or older interferon-based treatments
• People considered at high risk of giving birth early — either because they have previously had a spontaneous premature birth before 34 weeks, or because an ultrasound during the current pregnancy showed the cervix measuring less than 20 mm
• People who have taken any medicines that are not allowed by the study within the 14 days before joining (confirm with trial site for the specific list)
• People with certain liver conditions, including a recent diagnosis of acute hepatitis not caused by hepatitis C with significantly elevated liver enzymes, or signs of serious liver disease such as internal bleeding, fluid build-up in the abdomen, confusion caused by liver failure, liver cancer, or other related complications
• People with any other significant health condition that, in the opinion of the trial doctor, could make participation unsafe, affect the reliability of the study results, or interfere with the goals of the trial

Important: Always verify eligibility with the trial site directly before applying.