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 @ 7:50 PM
Ignite Modification Date:
2025-12-24 @ 7:50 PM
NCT ID:
NCT02099604
Eligibility Criteria:
Inclusion Criteria:
Common with National Program for Viral Hepatitis
* Age: 18 years to 60 years
* Positive HCV antibodies using a third generation test
* Detectable HCV RNA by PCR
* Liver biopsy showing chronic hepatitis with either a METAVIR score F1 with elevated liver enzymes or scores F2/F3
* Naïve to treatment with PEG-IFN and RBV
* HBs antigen negative
* Prothrombin time ≥60 %, normal bilirubin, alpha-foeto protein \< 3\*normal range of the laboratory, anti-nuclear antibodies\<1/160 Effective contraception during the treatment period; no breast-feeding
Specific to the trial
* Prior approval from the Ministry of Health to be treated as part of the National Program with allocation to Peg-IFN α2b treatment
* Living \<100 km from Cairo and able to come to the centre every week for the treatment
* Signed informed consent and willingness to participate in the trial
* Naïve to treatment with vitamin D (received vitamin D less than 30 consecutive days in the 3 months preceding inclusion)
* Biopsy slide validated by NHTMRI pathologist
Exclusion Criteria:
Common with National program for Viral Hepatitis
* Serious co-morbid conditions such as severe hypertension, heart failure, significant coronary heart disease, poorly controlled diabetes (HbA1C\>8%) , chronic obstructive pulmonary disease
* Major uncontrolled depressive illness
* Solid transplant organ (renal, heart, or lung)
* Untreated thyroid disease
* History of previous anti-HCV therapy
* Body mass index (BMI) greater than 30 kg/m²
* Known human immunodeficiency virus (HIV) coinfection: although HIV testing will not be proposed or done, patients with known HIV coinfection will not be included in the trial
* Anti-HCV therapy contraindications:
* hypersensitivity to one of the two drugs (PEG-IFN, RBV)
* pregnancy or unwilling to comply with adequate contraception
* breast-feeding
* neutropenia (\<1500/mm3)
* anaemia (\<11g/dL for women ; \<12g/dL for men)
* thrombocytopenia (\<100,000/mm3)
* elevated creatinin (\>1.5mg/dL)
* concomitant liver disease other than hepatitis C (immuno-active chronic hepatitis B, autoimmune hepatitis, alcoholic liver disease, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson disease)
* liver biopsy showing severe steatosis (\>66%) and steatohepatitis; decompensated cirrhosis (Child Pugh\>A); hepatocellular carcinoma, METAVIR score F4.
* TSH\>5 mU/L
Specific to the trial
* Patients allocated to Peg-IFN alpha 2a treatment
* Hypersensitivity to vitamin D
* Vitamin D contraindications:
* hypercalcaemia (fasting calcaemia \>105 mg/L or 2.62 mmol/L)
* ratio calciuria / creatininuria (fasting ratio \>1 mmol Ca/mmol creatinin)
* hyperphosphatemia (\>1.5 mmol/L)
* calcium lithiasis
* patients being treated with thiazide diuretics (risk of hypercalcaemia with vitamin D treatment)
* patients being treated with glucocorticoïds (decrease in vitamin D efficacy)
* postmenopausal women treated by vitamin D and calcium for osteoporosis
* Treatment by vitamin D more than 30 consecutive days in the 3 months preceding inclusion in the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02099604
Study Brief:
Protocol Section:
NCT02099604