HELPS Study - A Study of Peginterferon Alfa-2a (Pegasys) in Patients With Chronic Hepatitis C (CHC) and End-Stage Renal Disease (ESRD)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Kidney Failure, Chronic
Intervention: Peginterferon alfa-2a
Intervention description: Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a either 135 or 90 mcg SC once weekly up to Week 48.
Intervention MeSH terms: Peginterferon alfa-2a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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