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:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT01641094
Eligibility Criteria:
Inclusion Criteria:
* Patients between 18 and 70 years of age, with a chronic hepatitis C - genotype 1 infection
* Patients are naive, non-responders or relapsers to previous treatment with peginterferon or conventional interferon plus ribavirin combination therapy
* High viral load (\>400,000 IU/ml)
* Indication for antiviral therapy of hepatitis C according to current clinical guidelines
Exclusion Criteria:
* Decompensated cirrhosis (Child-Pugh Grade B or C)
* Hepatic imaging (ultrasound, CT or MRI) with the evidence of hepatocellular carcinoma.
* Females who are pregnant or breast-feeding
* History or other evidence of severe illness, malignancy or any other condition which would make the patient, in the opinion of the investigators, unsuitable for the study
* Co-infections with human immunodeficiency virus (HIV) or Hepatitis B virus (HBV)
* Presence of contra-indications for antiviral therapy with telaprevir:
* Telaprevir is contraindicated when combined with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. Telaprevir in contraindicated when combined with drugs that strongly induce CYP3A and thus may lead to lower exposure and loss of efficacy of Telaprevir. The contraindicated medications include the following:
* Alfuzosin
* Rifampicin
* Dihydroergotamine, ergonovine, ergotamine, methylergonovine
* Cisapride
* St John's wort
* Atorvastatin, lovastatin, simvastatin
* Pimozide
* Sildenafil or tadalafil
* Triazolam
* Presence of contra-indications for antiviral therapy with peginterferon or ribavirin
* Severe psychiatric disorder, such as major psychoses, suicidal ideation, suicidal attempt and/or manifest depression.
* Visual symptoms related to retinal abnormalities
* Pregnancy, breast-feeding or inadequate contraception
* Thalassemia, spherocytosis
* Interfering substance abuse, such as high alcohol intake (indicator: 28 drinks/ week)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01641094
Study Brief:
Protocol Section:
NCT01641094