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 @ 5:52 PM
Ignite Modification Date:
2025-12-24 @ 5:52 PM
NCT ID:
NCT00495768
Eligibility Criteria:
Inclusion Criteria:
* Eligibility and interest in treatment for chronic HCV (Hepatitis C).
* Absence of co-infection of HIV or Hepatitis B.
* Age 25-68 years old.
* No treatment with IFN (interferon-alpha) in the past 6 months.
* Residence within a 3-hour drive of the clinic.
Exclusion Criteria:
* Patients must be willing to undergo treatment with PEG-interferon and ribavirin. They must be aware of the side effects of treatment and be motivated to self-administer the medications and come to regularly scheduled appointments.
* Patients with diabetes mellitus must have good glycemic control. Their Hgb A1 c must be \<8.0%.
* Patients must not have an active malignancy.
* If patients have a history of severe psychiatric illness or are found to have one by screening with the CES-D, a psychiatrist must approve treatment. If the psychiatric problem is minor, it can be managed by the primary care physician or hepatitis C provider.
* Autoimmune disease, such as autoimmune hepatitis, systemic lupus erythematosis, or sarcoidosis, is a contraindication to treatment.
* Active alcohol or intravenous drug use is a contraindication to treatment.
* Patients with a seizure disorder muct be seizure-free for 6 months prior to treatment.
* Patients with a known history of coronary heart disease are excluded.
* Patients with complications of cirrhosis may not be treatment candidates. Those who have a platelet count of \<50,000, large esophageal varices (grade 3-4), uncontrolled ascites, or uncontrolled encephalopathy are excluded.
* Patients with severe mental retardation or dementia are excluded because of difficulty in self-administration of medication and in tolerating the side effects.
* The patient and partner much agree to observe strict contraception to avoid pregnancy, since the medication is fetotoxic up to 6 months after treatment completion.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
68 Years
Study:
NCT00495768
Study Brief:
Protocol Section:
NCT00495768