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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT01463956
Eligibility Criteria:
Inclusion Criteria:
* Adult 18 years and older
* Chronic infection with hepatitis C virus proven with positive PCR for more than 6 months
* Viral genotype 1
* Cirrhosis while awaiting liver transplantation
* MELD score \< or equal to 18
* With or without hepatocellular carcinoma
* Naive to antiviral C treatment
* Failure on a previous treatment. Failure is defined as the persistence of detectable HCV RNA. The previous HCV failure treatment profile must be able to be documented according to the following terminology:- Relapsing patient: HCV RNA undetectable at the end of treatment, becoming detectable again after the discontinuation of treatment- Breakthrough: increase of viremia of 1 log or more during the treatment - Non-responding patient with partial response: HCV RNA detectable at W24 without ever having been undetectable and with a decrease in HCV RNA ≥ 2 log at W12 - Non-responding patient with nul response: decrease in HCV RNA \< 2 log at W12
* No need for prior treatment wash-out
* Negative pregnancy test in women of child-bearing age
* Double method of contraception in men and women of child-bearing age during the entire duration of treatment and the 6 months following its discontinuation
* Free, informed, and written consent (signed on the day of pre-enrollment at the latest and before all exams required by the study)
* Person enrolled in or a beneficiary of a social security/Universal Health Insurance Coverage
* Inclusion approved by the Decision Support Committee
Exclusion Criteria:
* Previous HCV treatment with boceprevir or telaprevir
* Alcohol consumption \> 40 g/day
* Toxicomania constituting a barrier for starting therapy according to the opinion of the investigator. Patients included in a methadone or buprenorphine replacement program may be enrolled
* MELD \> 18
* Non controlled sepsis
* Platelets \< 50,000/mm3
* Neutrophil granulocyte levels \< 1000/mm3
* Creatinine clearance \< 50 mL/min (MDRD)
* Hb \< 10 g/dL
* Uncontrolled psychiatric problems
* Contraindications to boceprevir
* Contraindication to interferon or ribavirin
* Subject with major complications of cirrhosis
* HIV coinfection
* HBV coinfection (unless this is treated effectively with analogues, as proven by undetectable viremia for at least 12 months)
* Other infectious disease underway
* Neoplastic disease other than hepatocellular carcinoma during the previous year, or neoplastic disease for which the prognosis is less than 3 years
* Treatment with immunosuppressors (including corticosteroids), antivirals other than those for the study, except aciclovir
* Consumption of St. John's wort
* Associated treatments including a molecule or substance that could interfere with the pharmacokinetic characteristics of boceprevir
* History of a lactose allergy
* Person participating in another study including an exclusion period that is still underway during pre-enrollment
* So-called vulnerable populations (minors, people under guardianship or protection, or a private individual under protection from making legal or administrative decisions)
* Pregnancy, breast-feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01463956
Study Brief:
Protocol Section:
NCT01463956