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 @ 3:33 PM
Ignite Modification Date:
2025-12-24 @ 3:33 PM
NCT ID:
NCT01535092
Eligibility Criteria:
Inclusion Criteria:
1. Patient must provide signed and dated informed consent before undergoing any trial related procedure.
2. Patient between 18 and 70 years of age.
3. Patient must have documented HCV infection. The HCV-RNA result obtained from the local laboratory at the screening visit must confirm HCV-RNA \> 1000 IU/mL.
4. Patient must qualify for liver transplantation at the time of Screening according to Model for End stage Liver Disease (MELD) criteria
5. Patient must have a documented diagnosis of cirrhosis.
6. Patient weigh between 50 kg and 100 kg.
7. Patients must be able to communicate, participate and comply with the requirements of the entire study.
8. Female patients of child-bearing potential must agree on using a contraceptive method (oral contraceptive, intrauterine device, transdermal contraceptive patch) and must have a negative pregnancy urine test at screening.
9. HCV Genotype, chest X-ray, ultrasonography and ocular examination (for patients with history of diabetes or hypertension) must be performed within 6 months prior to Screening or between Screening and Day 1. 12-Lead ECG must be performed within 3 months prior to Screening.
Exclusion Criteria:
1. Patients known to be coinfected with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive).
2. Active septic infections at time of screening.
3. Previous organ transplantation other than cornea and hair.
4. Use of systemic immunosuppressant or immunomodulating agents (including systemic corticosteroids) within 4 weeks of the screening visit or during the screening period.
5. Treatment for HCV with any investigational medication (prior use of silymarin is not exclusionary)
6. Treatment for HCV with any licensed therapies or prior maintenance therapy with any interferon alpha within 30 days of the randomization visit.
7. Participation in any other clinical trial within 30 days of randomization or intention to participate in another clinical trial during participation in this study.
8. Any known pre-existing medical condition that could interfere with the subject's participation in and completion of the study including but not limited to:
* Chronic pulmonary disease (eg, clinical chronic obstructive pulmonary disease, interstitial lung disease, pulmonary fibrosis, sarcoidosis).
* Current or history of any clinically significant cardiac abnormalities/dysfunction (eg, angina, congestive heart failure, myocardial infarction, pulmonary hypertension, complex congenital heart disease, cardiomyopathy, significant arrhythmia) including current uncontrolled hypertension, or history of use of antianginal agents for cardiac conditions.
* Any other condition which, in the opinion of a physician-investigator, would make the patient unsuitable for enrollment or could interfere with the subject participating in and completing the study.
9. Subjects who are part of the site personnel directly involved with this study or those who are family members of the investigational study staff.
10. If female, pregnancy or breast-feeding.
11. Known hypersensitivity to Legalon® SIL.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01535092
Study Brief:
Protocol Section:
NCT01535092