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 @ 2:19 PM
Ignite Modification Date:
2025-12-24 @ 2:19 PM
NCT ID:
NCT01072695
Eligibility Criteria:
Inclusion Criteria:
* Adult subjects, ages 18-70
* Willing able to provide informed consent
* BMI between 18 and 36 kg/m2 (inclusive)
* Chronic HCV infection, genotype 1
* HCV RNA \>/= 3 log, but \< 7.2 log10 IU/ml at screen
* Liver biopsy, FibroTest, or FibroScan indicating absence of cirrhosis
* HCV treatment naïve with imminent plans to start treatment with PEG/RIBA
* QTcF \</= 450 msec at screen
* ALT, AST, GGT \< 5 X ULN at the screening visit
* Creatinine clearance \>= 50 mL/min
* Absolute neutrophil count \>= 1500/mm3
* Hemoglobin \>/= 12 g/dL (female), \>/= 13 g/dL (male)
* Males agree to use of effective contraception and refrain from sperm donation
* Able to comply with dosing instructions and study visits
* Of generally good health
Exclusion Criteria:
* Females of child-bearing potential or males with female partners who are pregnant or planning to become pregnant
* Infection with other HCV genotype or multiple HCV genotypes
* Poorly controlled diabetes
* Hemoglobinopathy or known retinal disease
* History of sarcoidosis or invasive malignancy
* Untreated or significant psychiatric illness
* Co-infection with hepatitis B virus or human immunodeficiency virus
* Chronic use of systemic immunosuppressive agents
* Autoimmune disorders
* Severe COPD
* History of significant cardiac disease
* Known cirrhosis
* Non-HCV chronic liver disease
* Transplantation
* Suspicion of hepatocellular carcinoma
* Bilirubin above the normal range or Gilbert's syndrome
* Decompensated liver disease
* Clinically significant illness
* GI disease that could interfere with absorption
* Acute porphyria
* Current excessive alcohol ingestion, averaging \> 3 drinks/day for females and \> 4 drinks/day for males or current binge drinking
* Positive urine drug screen
* History of difficult blood collection
* Significant recent blood loss
* Prohibited medications, including H2 antagonists, investigational agents
* Restricted fruits, fruit juices
* Hypersensitivity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01072695
Study Brief:
Protocol Section:
NCT01072695