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:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT01625793
Eligibility Criteria:
Inclusion Criteria:
* Age 21-65 years including males, females and minorities
* Ability to speak and read remedial English
* Serum positive for either anti-HCV antibodies or HCV-RNA positive by PCR
* Compensated liver disease with the following minimum hematologic and biochemical criteria: hemoglobin ≥13 g/dl for males; ≥12 g/dl for females, white blood cell count \> 3,000/mm3, neutrophil count \>1,5000/mm3, platelets \> 100,000/mm3, prothrombin time ≤ 2 seconds prolonged compared to control, or equivalent INR ratio, albumin stable and within normal limits, serum creatinine within normal limits, thyroid-stimulating hormone within normal limits, direct bilirubin ≤ 0.3 mg/dl or within 20% of upper limit of normal (ULN) for local laboratory, indirect bilirubin ≤ 0.8 mg/dl or within 20% of ULN for local laboratory, fasting blood sugar ≤ 115 mg/dl or within 20% of ULN for non-diabetic patients
* Negative pregnancy test for women of childbearing potential, and confirmation and documentation that adequate contraception or monogamous relationship with a male partner who has had a vasectomy during the treatment period and for 6 months after discontinuation of therapy
* Not breastfeeding
* Documentation and confirmation of adequate contraception in sexually active males
* Free from all psychotropic medications for 14 days prior to baseline visit (8 weeks for fluoxetine)
Exclusion Criteria:
* Evidence of untreated or poorly controlled endocrine, cardiovascular, hematological, renal, or neurological disease
* Evidence of decompensated liver disease (such as a history or presence of ascites, bleeding varices, spontaneous encephalopathy)
* History of narcolepsy, PLMS or sleep apnea (or documented during the adaptation night)
* History of CNS trauma or active seizure disorder requiring medication
* Any cause for liver disease other than chronic hepatitis C, such as co-infection with hepatitis B virus and/or human immunodeficiency virus, hemochromatosis, or Wilson's diseases
* Prior treatment with ribavirin or other antiviral or immunomodulatory drugs, including corticosteroids within 6 months of entry into protocol
* Chronic use of agents known to affect monoamine metabolism/function (and hence potentially affect the TSST), including, but not limited to, alpha- and beta-receptor agonists and antagonists, methylphenidate hydrochloride, dextroamphetamine, midodrine hydrochloride, theophylline, ephedrine, systemic antifungal azoles, sumatriptan succinate
* Psychotropic medications within 14 days prior to baseline visit (8 weeks for fluoxetine)
* Clinical gout
* Hypersensitivity to alpha interferon or ribavirin
* Hemoglobinopathies (e.g. thalassemia)
* A positive pregnancy test
* Organ transplants
* A score of \<24 on the Mini Mental Status Exam (MMSE)
* Active, effective treatment of depression with an antidepressant within the past six months
* Actively meet criteria for major depression within the past six months
* Meet criteria for schizophrenia or bipolar disorder (mania) past or present
* Active abuse of alcohol or illicit/prescription drugs within the past year any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with participating in or completing the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT01625793
Study Brief:
Protocol Section:
NCT01625793