Phase 3
Completed N=81
HELPS Study - A Study of Peginterferon Alfa-2a (Pegasys) in Patients With Chronic Hepatitis C (CHC) and End-Stage Renal Disease (ESRD)
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT02806505 ↗
Enrolled (actual)
81
Serious AEs
34.6%
Results posted
Oct 2016
Primary outcomePrimary: Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Treatment — 39.5; 34.9 percentage of participants — p=0.6746
◆ Published Evidence
Emerging
1citation · ~0 / year
Interventions for dialysis patients with hepatitis C virus (HCV) infection.
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.
Linked Publications
-
Interventions for dialysis patients with hepatitis C virus (HCV) infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Treatment |
39.5; 34.9 | 0.6746 |
| SECONDARY Percentage of Participants With Virological Response (Non-detectable Hepatitis C Virus-ribonucleic Acid [HCV RNA]) at End of Treatment (EOT) |
57.9; 48.8 | 0.3923 |
| SECONDARY Percentage of Participants With Virological Response (at Least a 2-log 10 Decrease in HCV RNA as Compared With Baseline or Unquantifiable [Less Than {<} 600 International Unit/Milliliter {IU/mL}] or Undetectable HCV RNA [< 50 IU/mL]) at Week 12 and 24 |
71.1; 69.8; 65.8; 72.1 | 0.8843 |
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
Data sourced from ClinicalTrials.gov (NCT02806505) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.