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 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT00162734
Eligibility Criteria:
(Abbreviated due to space constraints.)
Inclusion Criteria:
1. Signed informed consent form
2. Previously randomized to the No-Treatment Arm in IRHC-001 protocol
3. IRHC-001 no-treatment patients ho have either \< 2 log10 reduction in plasma HCV RNA level by bDNA assay at Week 24 compared to baseline or detectable plasma HCV RNA by bDNA or TMA assays at Week 48
4. All patients and all potentially fertile sexual partners of patients must use 2 reliable forms of effective contraception during the study \& for 6 months after cessation of the study drugs
Exclusion Criteria:
1. Patients who experienced hepatic decompensation during IRHC-001 or show laboratory, clinical, or physiologic evidence of hepatic decompensation at screening for IRHC-002
2. Patients who, in the opinion of the Investigator or the Sponsor, are not suitable candidates for enrollment or who would not comply w/the requirements of the study
3. Pregnant or lactating women
4. Male partners of women who are pregnant
5. Patients who were on any experimental protocols or therapy while participating in IRHC-001
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00162734
Study Brief:
Protocol Section:
NCT00162734