Please select the eligibility criteria that correspond to the clinical trial below.
Title: Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial (HALT-C)
Brief Summary: The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases sponsored, randomized clinical trial of long-term use of Peginterferon alfa-2a (pegylated interferon) in patients who failed to respond to prior interferon treatment. All patients who enter the trial will be treated for 6 months with Peginterferon alfa-2a and Ribavirin. Patients who respond to this 6 month treatment will continue to be treated for an additional 6 months.

Patients who do not respond to this treatment will be eligible for the long-term maintenance phase of this study where patients will be randomly selected to be treated with Peginterferon alfa-2a or to discontinue treatment for 3.5 years. Patients in both arms of this study will be followed closely with quarterly study visits.

The combination of peginterferon plus ribavirin has recently been approved by the FDA for treatment of chronic hepatitis C. Patients who remain HCV-RNA positive after being treated for at least 6 months with peginterferon and ribavirin outside of this study may be eligible to directly enter the randomized portion of the HALT-C Trial.

The HALT-C study is designed to determine if continuing interferon long-term over several years will suppress Hepatitis C virus, prevent progression to cirrhosis, prevent liver cancer and reduce the need for liver transplantation.


Options:
A: Inclusion Criteria:

* Participant must have previously documented CHC genotype 1 infection.
* Participant must have a liver biopsy with histology consistent with CHC and no other etiology.
* Participants with bridging fibrosis or cirrhosis must have an ultrasound within 6 months of the Screening Visit (or between Screening and Day 1) with no findings suspicious for hepatocellular carcinoma (HCC).
* Participant must be \>=18 years of age.
* Participant must weigh between 40 kg and 125 kg.
* Participant and participant's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations.
* Participants must be willing to give written informed consent.

Exclusion Criteria:

* Coinfection with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive).
* Participants who received prior treatment for hepatitis C; other than herbal remedies, except those with known hepatotoxicity.
* 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 including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
* Diabetic and/or hypertensive participants with clinically significant ocular examination findings: retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or any other clinically significant abnormality.
* Pre-existing psychiatric condition(s).
* Clinical diagnosis of substance abuse of the specified drugs within the specified timeframes.
* Any known pre-existing medical condition that could interfere with the participant'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). Participants under evaluation for malignancy are not eligible.
* 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.
* Any other condition which, in the opinion of a physician, would make the participant unsuitable for enrollment or could interfere with the participant participating in and completing the study.
* Participants who are part of the site personnel directly involved with this study.
* Participants who are family members of the investigational study staff.
* Participants who had life-threatening serious adverse event (SAE) during screening period.
* Protocol-specified hematologic, biochemical, and serologic criteria: 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; Direct bilirubin \>1.5 x upper limit of normal (ULN)
* Serum albumin \< lower limit of normal (LLN)
* Thyroid-stimulating hormone (TSH) \>1.2 x ULN or \<0.8 x LLN of laboratory, with certain exceptions.
* Serum creatinine \>ULN of the laboratory reference.
* Protocol-specified serum glucose concentrations.
* protocol-specified alpha fetoprotein levels.
* Prothrombin time/partial thromboplastin time (PT/PTT) values \>10% above laboratory reference range.
* Anti-nuclear antibodies (ANA) \>1:320.
B: Inclusion Criteria:

* Age at entry 18-65 years;
* Non-responders to previous treatment (minimum of 3 months) with an alpha interferon plus ribavirin;
* Liver biopsy demonstrating cirrhosis

Exclusion Criteria:

* Any other cause for liver disease other than chronic hepatitis C;
* History or presence of complications of cirrhosis;
* Alcohol or illicit drug abuse or treatment with methadone within the past 2 years;
* Diseases or conditions that could interfere with participation in the study
C: Inclusion Criteria:

* Age at entry at least 18 years.
* Positive for Hepatitis C.
* Previous treatment with any interferon or interferon and ribavirin for at least 3 months.
* Documented non-response to treatment with interferon.
* A liver biopsy demonstrating significant liver scarring.

Exclusion Criteria:

* No other liver disease.
* No unstable major medical diseases or conditions.
* No major complications of cirrhosis.
* No recent abuse of alcohol or illicit drugs.
D: Inclusion Criteria

* Has not received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C
* Male and female subjects, 18 to 70 years of age, inclusive
* Genotype 1, chronic hepatitis C with detectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
* Screening laboratory values, tests, and physical exam within acceptable ranges
* Able and willing to follow contraception requirements
* Able to read and understand, and willing to sign the informed consent form and abide by the study restrictions

Exclusion Criteria

* Subject has any contraindications to Pegasys® or Copegus® therapy
* Evidence of hepatic decompensation in cirrhotic subjects
* History of organ transplant
* History of, or any current medical condition which could impact the safety of the subject in participation in the study

Answer: C