HELPS Study - A Study of Peginterferon Alfa-2a (Pegasys) in Patients With Chronic Hepatitis C (CHC) and End-Stage Renal Disease (ESRD)

A Randomized, Open-Label, Multicenter, Parallel Group Study Evaluating the Efficacy and Safety of 135 μg and 90 μg of PEGASYS® Given as Monotherapy to Patients With Chronic Hepatitis C and End-Stage Renal Disease Undergoing Hemodialysis

This study evaluated the safety and efficacy of peginterferon alfa-2a monotherapy in participants with Chronic Hepatitis C (CHC) who have End-Stage Renal Disease (ESRD) and were undergoing hemodialysis.

Inclusion Criteria:

• Serum hepatitis C virus ribonucleic acid (HCV RNA) quantifiable at greater than (>) 600 IU/mL
• Liver biopsy consistent with chronic hepatitis C infection obtained within 2 years of enrollment
• Compensated liver disease without cirrhosis
• Participants with end-stage renal disease undergoing hemodialysis
• Negative serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
• All fertile participants must have been using effective contraception during treatment with study drug

Exclusion Criteria:

• Interferon therapy at any previous time
• Liver cirrhosis
• Signs and symptoms of hepatocellular carcinoma
• History or other evidence of decompensated liver disease
• Any investigational drug less than or equal to 6 weeks prior to the first dose of study drug
• History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
• Poorly controlled diabetes
• Thyroid dysfunction not adequately controlled
• Evidence of severe retinopathy or clinically relevant ophthalmological disorder
• Severe hyperparathyroidism defined as intact Parathyroid Hormone (PTH) > 800 picogram/milliliter (pg/mL)
• Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment ≤ 6 months prior to the first dose of study drug
• Acute renal failure
• Women with ongoing pregnancy or breast feeding
• Positive test at screening for anti-HAV IgM Ab (hepatitis A virus immunoglobulin M antibody), hepatitis B surface antigen (HBsAg), anti-HBc (hepatitis B core) IgM Ab, anti-HIV (human immunodeficiency virus) Ab