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 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT01641666
Eligibility Criteria:
Inclusion Criteria:
* Weight ≥ 40 kg to ≤ 125 kg
* Sexually active male participants and female participants of child-bearing potential must agree to use a medically acceptable form of contraception
* Must have documented Chronic Hepatitis C Genotype 1 infection
* Must have failed prior treatment with interferon plus ribavirin
* Must have completed treatment with interferon plus ribavirin for at least 12 weeks
* Must have had a liver biopsy or Fibroscan to determine status as cirrhotic or non-cirrhotic
* Participants with cirrhosis must have had an ultrasound or imaging study within 6 months of the Screening visit
Exclusion Criteria:
* Known co-infection with the human immunodeficiency virus (HIV) or the hepatitis B virus
* Prior discontinuation of treatment with interferon or ribavirin due to the occurrence of an adverse event(s) considered by the investigator to be possibly or probably related to the treatment
* Treatment with ribavirin within 90 days and any interferon within 1 month of the Screening visit
* Treatment with any investigational drug within 30 days prior to the Screening visit
* Treatment with midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, or ergot derivatives within 2 weeks prior to the Day 1 visit
* Participation in any investigational trial within 30 days of the Screening visit
* Evidence of decompensated liver disease
* Child Pugh score \> 6 (Class B and C)
* Diabetic and/or hypertensive participants with clinically significant ocular examination findings
* Pre-existing psychiatric conditions
* Clinical diagnosis of substance abuse
* Active or suspected malignancy
* Pregnant or nursing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01641666
Study Brief:
Protocol Section:
NCT01641666