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 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
NCT ID:
NCT02309450
Eligibility Criteria:
Inclusion Criteria:
* Adult ≥18 years
* Infection with HCV genotype 4, confirmed by detectable HCV RNA ≥ 1000 IU/ml at pre-inclusion
* Failure to a prior treatment with pegylated Interferon and Ribavirin, with failure being defined as follows:
* Non-response: HCV viral load remaining detectable during and at the end of P/R treatment.
* Relapse: undetectable HCV viral load during P/R treatment and detectable after the end of the treatment.
* HCV breakthrough: undetectable HCV viral load during P/R treatment becoming detectable before the end of treatment.
* Anti-HCV treatment discontinued for at least the last 3 months
* Fibrosis at any stage, with documentation of the presence or absence of cirrhosis at the pre-inclusion visit:
* history of liver biopsy showing cirrhosis lesions (METAVIR F4), at any time in the patient's history, or
* good quality (length ≥ 1 cm and ≥ 5 portal spaces) liver biopsy dating from less than 18 months to establish the METAVIR, or
* hepatic impulse elastometry (Fibroscan®) dating from less than 6 months and of good quality (at least 10 measurements on an incidence with IQR of less than 30% of the median elastometry measured and a success rate of 60%) or
* interpretable Fibrotest® dating from less than 6 months The proportion of patients with cirrhosis will be limited to 50% of all patients included, cirrhosis being defined as a METAVIR score of F4 on the liver biopsy or an hepatic impulse elastometry ≥ 14 kPa or a Fibrotest® result \> 0,75.
* Men and women of a child-bearing age and their heterosexual partners must use adequate contraception during treatment and up to 8 weeks after the end of treatment for women, 12 weeks after the end of treatment for men.
* Written informed consent signed by the patient and the investigator (on the day of the pre-inclusion at the latest and before any examination required by the study) (article L1122-1-1 Public Health Code)
* Patients with Health insurance (Sécurité Sociale or Couverture Médicale Universelle)
Exclusion Criteria:
Medical history
* CHILD B or C cirrhosis
* Previous HCV therapy including HCV NS3 protease inhibitor, and/or HCV NS5A replication complex inhibitor and/or HCV NS5B polymerase inhibitor
Current condition
* Positive HBs Antigen
* Confirmed HIV-1 or HIV-2 infection
* Pregnant or breast-feeding women
* Transplant recipients
* Any evolutive ongoing malignant disease, including hepatocellular carcinoma, which will be specifically screened for before inclusion
* Consumption of alcohol which, in the investigator's opinion, will be an obstacle to the patient's participation and to his/her remaining in the study
* Drug addiction which, in the investigator's opinion, will be an obstacle to the patient's participation and to his/her remaining in the study. Patients included in a programme of substitution with methadone or buprenorphine could be included. The opinion of an addictology consultant is recommended for patients presenting with current drug use or drug use in the past year.
* Patients taking part in another clinical trial during the 30 days prior to inclusion
* Patient under guardianship, trusteeship or judicial protection
Biological criteria
* ALT ≥ 5xULN
* Total bilirubin ≥ 34 µmol/L, unless a documented history of Gilbert's disease
* Hb \< 85 g/L
* Platelets \< 50 000/mm3
* Kidney failure defined by creatinine clearance \< 50mL/mn (MDRD formula)
* QTc \> 440 msec for males or 460 msec for females
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02309450
Study Brief:
Protocol Section:
NCT02309450