Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT02971033
Eligibility Criteria:
Inclusion Criteria:
* Males/females 18 - 70 yrs of age
* Serum HCV RNA \>2,000 IU/ml
* Hepatitis C genotype 1
* Other causes of chronic liver disease excluded by appropriate clinical, laboratory, or histologic evaluation
* The following hematological criteria must be met:
* Hemoglobin \> 12 g/dl
* Absolute neutrophil count (ANC) \> 1.0x109 /L
* Platelets 150 x 108 /L (i.e normal)
* Serum creatinine \<1.5 times the upper limit of normal (ULN) at screening.
* Fasting blood sugar normal for non-diabetics or hemoglobin A1C \< 8.5% with diabetes
* Women of childbearing potential must have a negative pregnancy test prior to receiving treatment. Sexually active women must take adequate precautions to prevent pregnancy during the study. Pregnancy tests will be done at the final clinic visits and every 4 weeks
* Patient provides written informed consent
Exclusion Criteria:
* Evidence of liver disease other than HCV:
* Antinuclear antibodies (ANA) \>1:160
* Active alcoholic liver disease.
* Hepatitis B surface antigen positive
* Hemochromatosis
* Wilson disease
* Alpha-1-antitrypsin deficiency
* Recent hepatotoxic drug exposure
* Cirrhosis with complications of portal hypertension including esophageal varices (\> grade 1 by endoscopy), ascites, or hepatic encephalopathy, or bilirubin \>2.0 mg/dl
* Patients with advanced fibrosis (defined herein as decompensated cirrhosis, FIB4 \> 2.5, platelet count \<150 x 103/uL, clinical or radiographic evidence of cirrhosis)
* Extrahepatic manifestations of liver disease or HIV co-infection
* Use of fibric acid, Fenofibrate or cholestyramine
* Active substance abuse including, but not limited to alcohol or i.v./inhaled drugs
* Use of chemotherapy or systemic steroid therapy within 30 days prior to enrollment
* Pregnancy, females who are breast feeding, or females of child bearing potential who are not using adequate birth control measures
* History of a medical condition that could interfere with participation or completion of the protocol
* Organ transplant recipient
* History of hypersensitivity to ezetimibe
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02971033
Study Brief:
Protocol Section:
NCT02971033