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 @ 11:11 PM
Ignite Modification Date:
2025-12-24 @ 11:11 PM
NCT ID:
NCT00433069
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed chronic hepatitis C as per liver biopsy performed during the 12 months prior to enrollment (except patients with histologically proven cirrhosis or a Actitest/Fibrotest assay, or a Fibroscan performed during the 12 months prior to enrollment)
* HCV RNA in serum \>600 IU/ml
* elevated ALT
* HCV genotypes 1, 2, 3 or 4
* failure to respond to a prior treatment with a pegylated interferon alpha + ribavirin
* HOMA score \> 2.00
* documentation that sexually active female patients of childbearing potential are practicing adequate contraception (intrauterine device, oral contraceptives, progesterone implanted rods, medroxyprogesterone acetate, surgical sterilization plus a barrier method \[diaphragm + spermicide\] or monogamous relationship with a male partner who has had a vasectomy or is using a condom + spermicide) during the treatment period and for 6 months after discontinuation of therapy. A serum pregnancy test obtained at entry prior to the initiation of treatment must be negative. Female patients must not be breast feeding
* documentation that sexually active male patients are practicing acceptable methods of contraception (vasectomy, use of a condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 6 months after discontinuation of therapy
* willingness and capability to give written informed consent and to comply with the requirements of the trial
Exclusion Criteria:
* history of diabetes (ADA definition)
* history of significant cardiovascular disease (NYHA III) including but not limited to uncontrolled hypertension, angina pectoris, myocardial infarction, coronary artery surgery and congestive heart failure
* HBsAg and/or HIV
* auto-immune disease, including auto-immune hepatitis
* alcohol consumption exceeding 40 grams per day
* hepatocellular carcinoma
* renal insufficiency (serum creatinine levels above 200 micromol/l)
* unconjugated bilirubin blood level \> 100 micromol/l
* glutamyl transferase \> 20 times the ULN
* prothrombin time \< 60% of control (except in case of oral anti-coagulant therapy)
* neutrophil count \< 1.5 G/L
* platelet count \< 70 G/L
* hemoglobin \<120 g/L
* organ or bone marrow transplantation
* current neoplasm and/or anti-tumor chemotherapy
* current hepatic arterial thrombosis
* pregnant or breast feeding women; child bearing potential women without adequate contraception throughout the course of therapy
* psychosis or anti-depressant therapy for uncontrolled clinical depression
* epilepsy
* clinically significant retinal abnormalities
* thyroid dysfunction
* drug abuse or substitution therapy during the 12 months prior to inclusion
* interstitial pneumonitis
* previous auto-immune hemolysis and all causes of chronic hemolysis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00433069
Study Brief:
Protocol Section:
NCT00433069