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 @ 9:49 PM
Ignite Modification Date:
2025-12-24 @ 9:49 PM
NCT ID:
NCT00905632
Eligibility Criteria:
Inclusion criteria:
1. HCV genotype 1
2. HCV viral load \>100,000 IU/mL
3. histology or fibroscan to rule out cirrhosis
4. Absence of retinopathy
5. treatment naive patients and treatment experienced patients
6. Age 18 - 70 years
7. Male OR female with documented hysterectomy OR postmenopausal
Exclusion criteria:
1. Fertile males not willing to use an adequate form of contraception
2. Pretreatment with any HCV-polymerase inhibitor
3. Any concurrent disease if clinically significant based on the investigator's medical assessment
4. Current alcohol or drug abuse, or history of the same
5. Positive test for HIV or HBs
6. History of malignancy
7. Planned or concurrent usage of any other pharmacological therapy including any antiviral therapy or vaccination
8. Usage of any investigational drug within thirty (30) days prior to enrolment or 5 halflives, whichever is longer
9. Any clinically significant laboratory abnormalities based on the investigator's medical assessment at screening
10. Patients treated with any interferon (approved or investigational) or Peg-IFN and/or Ribavirin within 3 months prior to screening
11. Known hypersensitivity to drugs or excipients; Further exclusion criteria apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00905632
Study Brief:
Protocol Section:
NCT00905632