Phase 3 Hepatitis C Trial, Completed

Written by an AI model from the 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 aged over 18 years, both male and female
• People who have been confirmed to have a long-term hepatitis C virus (HCV) infection
• People who are considered suitable candidates for a combination antiviral treatment called peginterferon and ribavirin
• People whose platelet count (a measure of blood clotting cells) is below 75,000 per microlitre
• People whose haemoglobin level (a measure of red blood cells) is above 11.0 g/dL for men, or above 10.0 g/dL for women
• People whose neutrophil count (a type of immune cell) is above 750 per cubic millimetre, and who have no history of infections linked to low neutrophil levels
• People whose kidneys are working well enough to clear waste at a rate above 50 mL per minute
• People who are able to use two effective forms of contraception during treatment and for 24 weeks after treatment ends (this applies to all people who are capable of having children)
• People who are able to understand what the trial involves, give their consent, follow the study requirements, and are expected to complete the full study

Who may not be able to join:

• People who previously received a full course of peginterferon and ribavirin treatment but did not respond to it — unless the reason for not responding was a low platelet count
• People whose liver disease has become severe, for example those with a Child-Pugh score above 6, or a history of or current fluid build-up in the abdomen (ascites), or episodes of confusion caused by liver failure (hepatic encephalopathy)
• People who have a known allergy, intolerance, or sensitivity to interferon, ribavirin, eltrombopag, or any of their ingredients
• People who have serious heart, brain/blood vessel, or lung disease that would prevent safe treatment with peginterferon and ribavirin
• People who have attempted suicide or been hospitalised for depression in the past 5 years
• People who currently have a severe or poorly controlled mental health condition
• People who had a severe or poorly controlled mental health condition more than 6 months ago but less than 5 years ago may be able to participate, but would first need to be assessed by a mental health professional and followed up if recommended
• People who have a seizure disorder that has not been well controlled
• People who have had a significant episode of bleeding from swollen veins in the oesophagus or stomach (oesophageal or gastric varices)
• People who have blood disorders affecting the shape or function of red blood cells, such as sickle cell anaemia or thalassemia major
• People who have a history of a blood clot in an artery or vein, AND also have two or more of the following risk factors: an inherited clotting disorder, hormone replacement therapy, hormonal contraception containing oestrogen, smoking, diabetes, high cholesterol, medication for high blood pressure, or cancer treatment
• People who have significant pre-existing heart disease classified as Grade III or IV by standard heart disease scales, or certain heart rhythm problems linked to a risk of blood clots, or a heart electrical measurement (QTc interval) above 450 milliseconds
• People who have signs of liver cancer (hepatocellular carcinoma)
• People who have HIV infection or an active hepatitis B virus infection
• People who have a condition associated with active bleeding, or who need blood-thinning medications such as heparin or warfarin
• People who have received cancer treatment or immune-modifying treatment within 6 months before the first dose of the study drug
• People who have been diagnosed with or treated for cancer within the past 5 years — with some exceptions, such as certain skin cancers treated by surgical removal, or people whose cancer has been fully treated and where a cancer specialist considers the outlook to be excellent (confirm with trial site)
• Women who are pregnant or breastfeeding
• Men whose female partner is currently pregnant
• People who have had issues with alcohol or drug dependence within 6 months before the study starts, unless they are currently enrolled in a supervised rehabilitation programme
• People who have taken an experimental drug or interferon within 30 days or 5 half-lives (whichever is longer) before their screening visit
• People who have a history of platelet clumping that makes it impossible to get a reliable platelet count reading
• People who have had a major organ transplant and still have a working transplanted organ
• People who have a thyroid condition that is not adequately managed
• People who are planning to have cataract surgery during the study period
• People who have shown signs of a blood clot in the portal vein (the main vein supplying the liver) on a scan taken within 3 months before the start of the study

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