Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Safety and Efficacy Study of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1
Brief Summary: This was an open-label, randomized safety and efficacy trial in adult, treatment-naïve Chronic Hepatitis C (CHC) participants with genotype 1 infection. The study conducted in 2 parts, compared standard-of-care PegIntron (1.5 μg/kg, once weekly \[QW\]), plus ribavirin (800 to 1400 mg/day), for 48 weeks to five treatment paradigms containing boceprevir (SCH 503034) 800 mg thrice a day (TID). The five treatments included boceprevir (BOC) plus standard-of-care for 28 or 48 weeks, with and without a 4-week lead-in with PegIntron (PEG) and ribavirin (RBV), and exploration of PegIntron plus low-dose ribavirin (400 to 1000 mg/day) plus boceprevir for 48 weeks.


Options:
A: Inclusion Criteria:

* Males and females between 18 and 70 years old
* Detectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) greater than or equal to (\>=) 10,000 international units per milliliter (IU/mL)
* Must have chronic hepatitis C (genotype 1) and have already received at least one prior course of pegylated interferon alfa 2a with ribavirin
* Cannot also be infected with Human Immunodeficiency Virus or hepatitis B
* Must be judged to be in general good health and able to receive Pegasys® and Copegus®
* No drug or alcohol abuse in the last year
* Must agree to use two effective methods of birth control during the study and for 6 months after you stop taking study medication. One of the methods needs to be a 'barrier' method (condom or diaphragm)
* If you are a woman, you cannot be in this study if you are pregnant or nursing

Exclusion Criteria:

* Participation in any clinical trial of a HCV protease inhibitor of any duration
* Prior response to therapy and failure to achieve SVR which was due to treatment non-compliance
* Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis
* Diagnosed or suspected hepatocellular carcinoma
* History of or current evidence of decompensated liver disease
* Participation in any clinical trial of an investigational drug within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study)
B: Inclusion Criteria:

* adult patients, 18-65 years of age;
* chronic hepatitis C, genotype 1;
* chronic liver disease consistent with CHC;
* compensated liver disease.

Exclusion Criteria:

* infection with any HCV genotype other than genotype 1;
* previous treatment for CHC;
* medical condition associated with chronic liver disease other than CHC;
* HIV, hepatitis A, hepatitis B infection.
C: Inclusion Criteria:

* Documented chronic (at least 6 months) HCV GT 1 infection (with no evidence of mixed genotypes or genotype that cannot be assigned a type)
* Evidence or no evidence of liver cirrhosis based on one of the following:
* Liver biopsy performed within 24 months of Day 1 (if participant is cirrhotic then there is no time restriction on biopsy)
* Fibroscan performed within 12 months of Day 1 of this study
* Fibrosure™ (Fibrotest™) plus aspartate aminotransferase to platelet Ratio Index \[APRI\] obtained during the screening period)
* Has HCV status that is one of the following:
* Treatment naïve
* Prior interferon or pegylated interferon with or without ribavarin failures (null responder, partial responder, or relapser)
* Intolerant to prior interferon or pegylated intereferon with or without ribavarin regimen
* Chronic kidney disease (defined as glomerular filtration rate \[eGFR\] \<=29) non-dialysis dependent or on hemodialysis for at least 3 months, including individuals awaiting kidney transplant and those with failed kidney transplants but no longer on immunosuppressant therapy)
* Female participant of reproductive potential must agree to remain abstinent or use (or have their partner use) 2 acceptable methods of contraception from at least 2 weeks prior to Day 1 through 14 days after the last dose of study drugs, or longer if dictated by local regulations

Exclusion Criteria:

* Evidence of decompensated liver disease
* On peritoneal dialysis for management of kidney disease
* Co-infection with hepatitis B virus or human immunodeficiency virus (HIV)
* History of malignancy \<=5 years prior to signing informed consent
* Clinical diagnosis of substance abuse
* Pregnant, breast-feeding, expecting to conceive or donate eggs, or donate sperm from Day 1 through 14 days after the last study dose, or longer if dictated by local regulations
* Organ transplant (including hematopoietic stem cell transplant) other than kidney, cornea, and hair
* Conditions requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
* Uncontrolled or poorly controlled hypertension
* Significant cardiovascular disorder (e.g. myocardial infarction or unstable angina) or cardiovascular procedure within 3 months prior to signing informed consent
* New or worsening signs or symptoms of congestive heart failure within 3 months of signing informed consent
* Severe active peripheral vascular disease
* Recent (within 3 months prior to signing informed consent) episode or recurrence of stroke, transient ischemic attack (TIA) or neurological disorder, including but not limited to seizures
* Evidence or history of chronic hepatitis not caused by HCV
D: Inclusion Criteria:

* Age between 18 and 60 years;
* Body weight between 45 and 125 kg;
* Documented chronic hepatitis C genotype 1;
* Liver biopsy with histology consistent with chronic hepatitis and no other etiology for chronic liver disease within of 5 years of Day 1;
* Participant and participant's partner(s) must each agree to use acceptable methods of contraception 2 weeks prior to Day 1 and at least 6 months after the last dose of study medication;
* Written informed consent.

Exclusion Criteria:

Include, but are not limited to, the following:

* Prior treatment for hepatitis C;
* Co-infection with HIV or hepatitis B virus (HBsAg positive);
* Evidence of decompensated liver disease;
* Diabetic and hypertensive participants with clinically significant ocular exam findings;
* Pre-existing psychiatric condition, including but not limited to:

  * Current moderate or severe depression;
  * History of depression associated with any of the following:

    * Hospitalization for depression;
    * Electroconvulsive therapy for depression;
    * Depression that resulted in a prolonged absence from work and/or significant disruption of daily functions;
  * Suicidal or homicidal ideation and/or attempt;
  * History of severe psychiatric disorders (including but not limited to schizophrenia, psychosis, bipolar disorder, post-traumatic stress disorder or mania);
  * Past history or current use of lithium;
  * Past history or current use of antipsychotic drugs for listed conditions.
* Substance abuse within protocol specified timeframes;
* Pre-existing medical conditions that could interfere with the participant's participation in and completion of the study, including but not limited to chronic pulmonary disease, cardiac dysfunction or immunologically-mediated disease;
* Active or suspected malignancy or history of malignancy within the past 5 years;
* Participants who are pregnant or nursing; participants who intend to become pregnant during the study period. Male participants with partners who are, or intend to become, pregnant during the study period.
* Treatment with any investigational drug or participation in any clinical trial 30 days within Screening;
* Hemoglobin \<12 g/dL for females and \<13 g/dL for males;
* Neutrophils \<1500 mm\^3; Blacks: \<1200/mm\^3;
* Platelets \<100,000/mm\^3;
* Other clinically significant laboratory test abnormalities.

Answer: D