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:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
NCT ID:
NCT02480712
Eligibility Criteria:
Key Inclusion Criteria:
* HCV RNA ≥ 10\^4 IU/mL at screening
* HCV genotype 1, 2, 3, 4, 5, 6
* Cirrhosis determination, a fibroscan or liver biopsy may be required
* HIV-1 infection
* Use of protocol specified method(s) of contraception
* Screening laboratory values within defined thresholds
Key Exclusion Criteria:
* Clinically-significant illness (other than HCV or HIV) or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
* Current or prior history of clinical hepatic decompensation, hepatocellular carcinoma (HCC) or other malignancy (with the exception of certain resolved skin cancers)
* Screening ECG with clinically significant abnormalities
* Pregnant or nursing female or male with pregnant female partner
* Infection with hepatitis B virus (HBV)
* Use of any prohibited concomitant medications as described in the protocol
* Chronic use of systemically administered immunosuppressive agents
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02480712
Study Brief:
Protocol Section:
NCT02480712