Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Placebo-controlled, Dose-ranging Study to Evaluate the Safety, Tolerability and Antiviral Activity of Combination Treatment With an HCV Polymerase Inhibitor (RO5024048) and an HCV Protease Inhibitor (RO5190591) in Genotype 1 Chronic Hepatitis C Patients. INFORM 1
Brief Summary: This 7 cohort study will evaluate the efficacy and safety of combination treatment with an HCV nucleoside polymerase inhibitor(RO5024048)and an HCV protease inhibitor(RO5190591/ITMN-191/danoprevir) in patients with chronic hepatitis C, genotype 1.Cohorts A,B,C,D and G will be treatment-naive patients, cohort E will be treatment-experienced excluding null responders, and cohort F will be null responders. Cohorts A and B will evaluate doses of 500mg po bid RO5024048 and 100mg po q8h RO5190591, alone or in combination, for up to 7 or 14 days. Cohort C will evaluate combination treatment with either 1000mg po bid RO5024048 and 100mg q8h RO5190591 or 500mg po bid RO5024048 and 200mg q8h RO5190591 for 14 days. Cohort D will evaluate 1000mg po bid RO5024048 and 200mg q8h RO5190591 for 14 days.Cohort E will evaluate 1000mg RO5024048/600mg RO5190591 po twice daily for 14 days, and Cohorts F and G will evaluate 1000mg RO5024048/900mg RO5190591 po twice daily for 14 days. Cohorts will be tested sequentially or in parallel, if supported by appropriate safety and pharmacokinetic data.Following the last dose of study medication patients have the option of continuing treatment with Standard of care therapies. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Options:
A: Key Inclusion Criteria:

* Patients chronically infected with hepatitis C virus (HCV) genotype 1
* HCV RNA viral load of ≥10\*5\* IU/mL (100,000 IU/mL) at screening
* Treatment naive

Key Exclusion Criteria:

* Women of child-bearing potential
* Cirrhosis
* Coinfection with HIV or hepatitis B virus
B: Inclusion Criteria:

* adult patients, 18-65 years of age;
* chronic hepatitis C, genotype 1.

Exclusion Criteria:

* decompensated liver disease, or impaired liver function;
* presence or history of non-hepatitis C chronic liver disease;
* HBsAg or HIV infection;
* history of cancer within 5 years, other than localized or in situ cancer of the skin.
C: Inclusion Criteria:

* Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
* Male or female between 18 and 70 years, inclusive, at time of Screening.
* Chronic HCV-infection prior to study enrollment.
* Screening laboratory result indicating HCV genotype 1-infection.
* Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening
* Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening.

Exclusion Criteria:

* Significant liver disease with any cause other than HCV as the primary cause
* Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab) at screening.
* Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir and boceprevir.
* Any current or past clinical evidence of Child-Pugh B or C Classification or clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy.
* A positive screening ultrasound for hepatocellular carcinoma (HCC) confirmed with a subsequent CT Scan or MRI during the screening period.
D: Inclusion Criteria:

* Patient has chronic Genotype 1 Hepatitis C infection

Exclusion Criteria:

* Subject has been previously treated for HCV
* Has Human Immunodeficiency Virus (HIV)
* Has Hepatitis B
* Has a history of clinically significant medical condition that may interfere with the study (e.g., stroke or chronic seizures or major neurological disorder) or is contraindicated for treatment with peg-IFN and Ribavirin

Answer: B