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 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT01441804
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years
* Serum Hepatitis C RNA \> 10,000IU/mL
* Hepatitis C virus genotype 1
* IL28B CC polymorphism
Exclusion Criteria:
* Previous treatment for chronic Hepatitis C
* clinical or biological evidence of acute hepatitis, including serum ALT or AST \> 300U/ml
* HIV antibody positive, hepatitis b surface antigen positive or known diagnosis of other chronic liver disease
* Contraindications to PR-based treatment:
* Uncontrolled psychiatric illness
* Active substance dependency
* Known autoimmune disorder
* Untreated thyroid disease
* Uncontrolled seizure disorder
* Pregnancy, lactation or inability to maintain contraception
* Chronic kidney disease w/ estimated GFR\< 60
* ANC\<1.5/nl, Hb\<12g/dl, or platelets\<75/nl
* Clinical or biochemical evidence of decompensated liver disease including:
* History of encephalopathy
* Ascites
* Variceal bleeding
* Bilirubin \> 3g/dl or INR \> 1.5
* Life threatening disorder with expected median survival less than 5 years
* Inability to comply with drug regimens or testing schedule required for study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
65 Years
Study:
NCT01441804
Study Brief:
Protocol Section:
NCT01441804