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 @ 4:04 PM
Ignite Modification Date:
2025-12-24 @ 4:04 PM
NCT ID:
NCT01655966
Eligibility Criteria:
Inclusion Criteria:
* Adult (male or female), 18 to 65 years of age, with chronic HCV infection
* Liver biopsy showing chronic hepatitis with significant fibrosis using Ishak scoring system
* Compensated liver disease; serum bilirubin \< 1.5 mg/dl, INR no more than 1.5, serum albumin \> 3.4, platelet count \> 75,000 mm, and no evidence of hepatic decompensation (hepatic encephalopathy or ascites)
* Acceptable hematological and biochemical indices (hemoglobin 12.5g/dl for men and 12 g/dl for women; neutrophil count 1500/mm3 or more and serum creatinine \< 1.5 mg/dl
* Patients must be serum hepatitis B surface antigen (HBsAg) negative
* Negative Antinuclear Antibodies (ANA) or titer of \< 1:160
* Serum positive for anti-HCV antibodies and HCV-RNA
* Abdominal Ultrasound obtained within 3 months prior to entry in the study
* Electrocardiogram for men aged \> 40 years and for women aged \> 50 years
* Normal fundus examination
* Proper contraception measure throughout the course of treatment and six months later
* Female patients must not breast feed during therapy
Exclusion Criteria:
* Patients who previously received interferon
* HgbA1c \> 7.5 or history of diabetes mellitus
* BMI \> 34
* Women who are pregnant or breast-feeding
* Males whose female partners are either pregnant or of child-bearing potential or not using birth control and are sexually active
* Other causes of liver disease including autoimmune hepatitis
* Transplant recipients receiving immune suppression therapy
* Screening tests positive for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab or anti-HIV Ab
* Decompensated cirrhosis, history of variceal bleeding, ascites, hepatic encephalopathy, CTP score \> 6 or MELD score \> 8
* Absolute neutrophil count \< 1500 cells/mm3; platelet count \< 135,000 cells/mm3; hemoglobin \< 12 g/dL for women and \< 12.5 g/dL for men; or serum creatinine concentration ≥ 1.5 times ULN
* Hypothyroidism or hyperthyroidism not effectively treated with medication
* Alcohol consumption of \> 40 grams per day or an alcohol use pattern that will interfere with the study
* History or other clinical evidence of significant or unstable cardiac disease
* History or other clinical evidence of chronic pulmonary disease associated with functional impairment
* Serious or severe bacterial infection(s)
* History of severe or uncontrolled psychiatric disease, including severe depression, history of suicidal ideation, suicidal attempts or psychosis requiring medication and/or hospitalization
* History of uncontrolled severe seizure disorder
* History of immunologically mediated disease requiring more than intermittent anti-inflammatory medications for management or that requires frequent or prolonged use of corticosteroids
* Patients with clinically significant retinal abnormalities
* Subjects receiving vitamin D for any other medical condition.
* Subjects with significant active rheumatologic or orthopaedic conditions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01655966
Study Brief:
Protocol Section:
NCT01655966