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

Roche

Status and phase: Completed; Phase 3

Conditions: Hepatitis C, Chronic

Treatments: Drug: Peginterferon alfa-2a

Study type: Interventional

Funder types: Industry

Identifiers

NCT02806505

MV17149

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

Peginterferon alfa-2a 135 microgram (mcg)

Experimental group

Description:

Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.

Treatment:

Drug: Peginterferon alfa-2a

Peginterferon alfa-2a 90 mcg

Experimental group

Description:

Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.

Treatment:

Drug: Peginterferon alfa-2a