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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT00323804
Eligibility Criteria:
Inclusion Criteria:
* Adults over 18
* With a hepatitis C virus infection (HCV RNA and anti-HCV antibodies in serum)
* Not responders to a previous antiviral treatment using the interferon plus ribavirin combination
* With a wash-out of treatment for at least 6 months
* With an active chronic hepatitis C and a Metavir fibrosis score ≥ 2
* Serum ALT levels \> upper limit of the laboratory on two occasions within 6 months before inclusion
* Accepting to undergo a liver biopsy at the end of the study
* Negative pregnancy test for women
* With a social security cover
* Written informed consent
Exclusion Criteria:
* History of hepatic complications
* History of transplantation
* History of severe seizures
* History of severe psychiatric disorders
* Drug addiction within the last 12 months
* Associated condition susceptible to be responsible for liver fibrosis
* Hepatocellular carcinoma
* Cardiovascular disease unstable under treatment
* Uncontrolled diabetes
* Retinopathy
* Thyroid disease unstable under treatment
* Epilepsy and/or central nervous system functional disorders
* Autoimmune disease
* Regular alcohol consumption
* Pregnancy, breast-feeding or absence of contraception
* Haemoglobin \<12 g/dl
* platelets \<50000/mm3
* Neutrophils \< 1200/ mm3
* Severe hepatocellular failure (prothrombin index lower than 60%)
* Renal failure (creatinine clearance lower than 50 mL/Mn)
* Associated immunosuppressive drugs, corticosteroids, antiviral drugs (other than study ones)
* Treatment with drugs likely to have an effect on fibrosis
* Anticonvulsants
* Inability to tolerate interferon
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00323804
Study Brief:
Protocol Section:
NCT00323804