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

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Interferon-alpha; Peginterferon alfa-2a

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