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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C, Chronic
• Intervention / Treatment: Drug: Peginterferon alfa-2a

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
  • Wien, Austria, 1090
• Brazil
  • Brasilia, Brazil, 70335-000
  • Porto Alegre, Brazil, 90035-003
  • Sao Jose Rio Preto, Brazil, 15090-003
  • Sao Luis, Brazil, 78048-790
  • Sao Paulo, Brazil, 04023-900
• France
  • Creteil, France, 94010
  • Le Kremlin-bicetre, France, 94275
  • Marseille, France, 13385
  • Paris, France, 75747
  • Strasbourg, France, 67091
  • Toulouse, France, 31059
• Greece
  • Athens, Greece, 11527
  • Nikea, Greece, 18354
• Indonesia
  • Medan, Indonesia, 20119
• Italy
  • Cagliari, Italy, 09134
• Turkey
  • Istanbul, Turkey, 34303
  • Istanbul, Turkey, 34390
  • Istanbul, Turkey, 34662
  • Izmir, Turkey, 35040
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peginterferon alfa-2a 135 microgram (mcg); 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.	Drug: Peginterferon alfa-2a; 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.; Other Names: Pegasys
Experimental: Peginterferon alfa-2a 90 mcg; 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.	Drug: Peginterferon alfa-2a; 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.; Other Names: Pegasys

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Treatment	SVR was defined as the percentage of patients with undetectable HCV RNA. SVR rate was calculated as the number of participants with an undetectable HCV RNA divided by the number of participants of the respective participant population. The last single HCV RNA less than (<) 50 international units per millilitre (IU/mL) measured >=140 days after treatment end (i.e., >= 20 weeks after treatment end) was used to determine SVR. Participants without measurements in this time window were considered to be nonresponders.	24 weeks after end of treatment (Week 72)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Virological Response (Non-detectable Hepatitis C Virus-ribonucleic Acid [HCV RNA]) at End of Treatment (EOT)	Virological response at the end of study treatment was defined as the percentage of participants with undetectable HCV RNA. This response rate at end of treatment was calculated as the number of participants with undetectable HCV RNA divided by the number of participants of the respective participant population.	EOT (Week 48)
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	Virological response at Weeks 12 and 24 was computed as the percentage of participants with at least a 2-log 10 decrease in HCV RNA at Weeks 12 and 24 as compared with baseline or with an unquantifiable (< 600 IU/mL) or an undetectable HCV RNA test result (< 50 IU/mL) at Week 12 and at Week 24, calculated as the number of participants meeting this criterion divided by the number of participants of the respective participant population.	Weeks 12 and 24

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): August 1, 2007
• Study Completion (Actual): August 1, 2007

Study Registration Dates

• First Submitted: June 16, 2016
• First Submitted That Met QC Criteria: June 16, 2016
• First Posted (Estimate): June 20, 2016

Study Record Updates

• Last Update Posted (Estimate): October 31, 2016
• Last Update Submitted That Met QC Criteria: September 9, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Kidney Diseases; Urologic Diseases; Liver Diseases; Renal Insufficiency; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Renal Insufficiency, Chronic; Hepatitis; Hepatitis A; Hepatitis C; Kidney Failure, Chronic; Hepatitis C, Chronic; Anti-Infective Agents; Antiviral Agents; Peginterferon alfa-2a
• Other Study ID Numbers: MV17149