Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of 4 Different Regimens of MK-7009 When Administered Concomitantly With Pegylated Interferon and Ribavirin in Treatment-Experienced Patients With Chronic Genotype 1 Hepatitis C Virus Infection
Brief Summary: The purpose of this study is to test the safety, tolerability, and efficacy of 4 regimens of Vaniprevir + Peg-IFN and Ribavirin as compared to Placebo (PBO) + Peg-IFN/RBV. The primary hypotheses are that Vaniprevir is well tolerated, and that Vaniprevir 600 mg twice daily (b.i.d.) is superior to the control regimen for the percentage of non-cirrhotic (NC) participants achieving undetectable HCV ribonucleic acid (RNA) 24 weeks after the end of study therapy (SVR24).


Options:
A: Inclusion Criteria:

* Infection with HCV genotype 1, 4, 5, or 6
* Cirrhosis determination
* Subject met the following classifications:

  * Treatment-naive
  * Screening laboratory values within defined thresholds
  * Not treated with any investigational drug or device within 30 days of screening
* Use of highly effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

* Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase
* Pregnant or nursing female, or male with pregnant female partner
* Current or prior history of clinical hepatic decompensation
* History of clinically-significant illness or any other major medical disorder that may have interfered with subject treatment, assessment, or compliance with the protocol
* Excessive alcohol ingestion or significant drug abuse
B: Inclusion Criteria:

* Chronically infected with Hepatitis C Virus (HCV) genotype 1
* Treatment naive or treatment non-responders or treatment intolerant; and not co-infected with HIV or Hepatitis B Virus
* HCV RNA viral load of ≥10\*5 IU/mL
* BMI 18 to 35kg/m²

Exclusion Criteria:

* Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with Hepatitis C Virus infection
* HIV and/or HBV positive
* Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug

WOCBP will be enrolled as in-patient for 16 days
C: Inclusion Criteria:

* Subjects must have a qualifying regimen defined as peginterferon alfa-2a/ribavirin or peginterferon alfa-2b/ribavirin for a minimum of 12 weeks.
* During the qualifying regimen, subjects must have either:

  * A documented undetectable Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) within 30 days of the end-of-treatment and a subsequent detectable HCV-RNA during follow-up OR
  * A documented decline in HCV-RNA by \>=2 log10 after 12 weeks of treatment.
* Subject must have previously documented chronic hepatitis C genotype 1 infection.
* Subject must have a liver biopsy with histology consistent with chronic hepatitis C infection and no other etiology.
* Subjects with bridging fibrosis or cirrhosis must have an ultrasound within 6 months with no findings suspicious for hepatocellular carcinoma (HCC).
* Subject must be \>=18 years of age.
* Subject must weigh between 40 kg and 125 kg.
* Subject and subject's partner(s) must each agree to use acceptable methods of contraception.
* Subjects must be willing to give written informed consent.

Exclusion Criteria:

Subject will be excluded from entry if ANY of the criteria listed below are

met:

* Subjects known to be coinfected with the human immunodeficiency virus (HIV) or hepatitis B virus (hepatitis B surface antigen \[HBsAg\] positive) and/or demonstrating signs and symptoms consistent with co-infection.
* Subjects who required discontinuation of previous interferon or ribavirin regimen for an adverse event considered by the investigator to be possibly or probably related to ribavirin and/or interferon.
* Treatment with ribavirin within 90 days and any interferon alfa within 1 month of Screening.
* Treatment for hepatitis C with any investigational medication. Prior treatment with herbal remedies with known hepatotoxicity is exclusionary.
* Treatment with any investigational drug within 30 days of the randomization visit in this study.
* Participation in any other clinical trial within 30 days of randomization or intention to participate in another clinical trial during participation in this study.
* Evidence of decompensated liver disease.
* Diabetic and/or hypertensive subjects with clinically significant ocular examination findings.
* Pre-existing psychiatric condition(s).
* Clinical diagnosis of substance abuse.
* Any known pre-existing medical condition that could interfere with the subject's participation in and completion of the study.
* Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin).
* Subjects who are pregnant or nursing. Subjects who intend to become pregnant during the study period. Male subjects with partners who are or who intend to become pregnant during the study period.
* Any other condition which, in the opinion of a physician, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study.
* Subjects who are part of the site personnel directly involved with this study.
* Subjects who are family members of the investigational study staff.
* Subjects who had a life-threatening serious adverse event (SAE) during the screening period.
* Subjects with a history of pancreatitis, except for one episode clearly secondary to gallstone.

Laboratory Exclusion Criteria:

* Hematologic, biochemical, and serologic criteria (growth factors may not be used to achieve study entry requirements):

  * Hemoglobin (Hgb) \<12 g/dL for females and \<13 g/dL for males
  * Neutrophils \<1500/mm3 (blacks: \<1200/mm3)
  * Platelets \<100,000/mm3
  * Direct bilirubin \>1.5 x upper limit of normal (ULN) of the laboratory reference range. Total bilirubin \>1.6 mg/dL unless the subject has a history of Gilbert's disease. If Gilbert's disease is the proposed etiology, this must be documented in the subject's chart.
* Serum albumin \< lower limit of normal (LLN) of laboratory reference range.
* Thyroid-stimulating hormone (TSH) \>1.2 x ULN or \<0.8 x LLN of laboratory reference range.
* Serum creatinine \>ULN of the laboratory reference range.
* Serum glucose:

  * For subjects not previously diagnosed with diabetes mellitus:

    * \>=140 mg/dL (nonfasting) unless hemoglobin A1c subtype (HbA1c) \<=7% OR
    * \>=100 mg/dL (fasting) unless HbA1c \<=7%.
  * For subjects previously diagnosed with diabetes mellitus: HbA1c \>8.5%.
* Prothrombin time/partial thromboplastin time (PT/PTT) values \>10% above laboratory reference range.
* Anti-nuclear antibodies (ANA) \>1:320.
* Alpha fetoprotein (AFP):

  * AFP \>100 ng/mL OR
  * AFP 50 to 100 ng/mL requires a liver ultrasound and subjects with findings suspicious for HCC are excluded.
D: Inclusion criteria:

* Has chronic HCV genotype 1 infection
* Is treatment-experienced
* For the non-cirrhotic population, has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma; for the cirrhotic population, has had a liver biopsy with evidence of cirrhosis and without evidence of hepatocellular carcinoma.

Exclusion criteria:

* Has not tolerated previous course peg-IFN and RBV
* Is unlikely to tolerate at least 24 weeks of continuous therapy with Peg-IFN and RBV
* Is co-infected with Human Immunodeficiency Virus (HIV) and/or hepatitis B
* Consumes excessive amounts of alcohol
* Has a history of drug or alcohol abuse
* If female, participant is pregnant or breastfeeding
* Has been in a clinical trail with an investigational drug in the last 30 days
* Has used IFN/Peg-IFN and RBV in the last 3 months

Answer: D