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 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT01425203
Eligibility Criteria:
Inclusion criteria:
* body weight ≥40 kg and ≤125 kg
* previously documented CHC genotype 1 infection;
* must have a liver biopsy with histology consistent with CHC and no other etiology
* if cirrhosis present, must have an ultrasound within 6 months of the screening visit (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma (HCC)
* agree to use acceptable methods of contraception with partner
* previously untreated with pegylated-interferon (either alfa-2a or alfa-2b) plus RBV or failing prior treatment with pegylated-interferon (either alfa-2a or alfa-2b) plus RBV
Exclusion criteria:
* co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus (Hepatitis B surface antigen \[HBsAg\] positive).
* required discontinuation of previous interferon or ribavirin regimen for an adverse event (possibly or probably related)
* treatment with ribavirin within 90 days and any interferon-alpha, based on the amendment, should be within 1 month prior to screening
* treatment with any investigational drug within 30 days of the screening visit in this trial
* evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
* diabetic and/or hypertensive with clinically significant ocular examination findings
* clinical diagnosis of substance abuse of specified drugs within specified timeframes
* any known pre-existing medical condition that could interfere with the participant's participation in and completion of the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01425203
Study Brief:
Protocol Section:
NCT01425203