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:
2025-12-24 @ 3:19 PM
Ignite Modification Date:
2025-12-24 @ 3:19 PM
NCT ID:
NCT01628692
Eligibility Criteria:
Key Inclusion Criteria:
* Hepatitis C virus (HCV) genotype 1a or 1b
* Males and females, ≥18 years of age
* HCV RNA ≥10,000 IU/mL
* Participants with compensated cirrhosis are permitted
* Advanced fibrosis (F3/F4) is capped at approximately 35% of the total treated population with a minimum of 20% F4 patients
* If no cirrhosis, a liver biopsy within 3 years prior to enrollment
* If cirrhosis is present, any prior liver biopsy
Key Exclusion Criteria:
* Liver or any other transplant (other than cornea and hair)
* Evidence of a medical condition contributing to chronic liver disease other than HCV infection
* Current or known history of cancer, (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
* Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
* Patients infected with HIV or hepatitis B virus
* Gastrointestinal disease impacting absorption of study drug
* Uncontrolled diabetes or hypertension
* Prior exposure to an HCV direct-acting agent
* Any criteria that would exclude the patient from receiving ribavirin
* Absolute neutrophil count \<1.5\*1,000,000,000 cells/L (\<1.2\*1,000,000,000 cells/L for Black/African Americans)
* Platelets \<90\*1,000,000,000 cells/L
* Hemoglobin \<12 g/dL for females, \<13 g/dL for males
* Alanine aminotransferase ≥5\*upper limit of normal
* In patients without cirrhosis, total bilirubin ≥2 mg/dL unless patient has a documented history of Gilbert's disease
* In patients with cirrhosis, total bilirubin o ≥1.5 mg/dL
* International normalized ratio ≥1.7
* QTcF or QTcB \>500 mSec
* Creatinine clearance ≤50 mL/min
* Alpha fetoprotein (AFP) \>100 ng/mL OR
* AFP ≥50 ng/mL and ≤100 ng/mL requiring liver ultrasound
* Albumin \<3.5 g/dL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01628692
Study Brief:
Protocol Section:
NCT01628692