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
1 other identifier
interventional
81
8 countries
22
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2004
Typical duration for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 16, 2016
CompletedFirst Posted
Study publicly available on registry
June 20, 2016
CompletedResults Posted
Study results publicly available
October 31, 2016
CompletedOctober 31, 2016
September 1, 2016
3.2 years
June 16, 2016
September 9, 2016
September 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Percentage of Participants With Virological Response (Non-detectable Hepatitis C Virus-ribonucleic Acid [HCV RNA]) at End of Treatment (EOT)
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
Weeks 12 and 24
Study Arms (2)
Peginterferon alfa-2a 135 microgram (mcg)
EXPERIMENTALChronic 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.
Peginterferon alfa-2a 90 mcg
EXPERIMENTALChronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Unknown Facility
Graz, 8036, Austria
Unknown Facility
Vienna, 1090, Austria
Unknown Facility
Brasília, 70335-000, Brazil
Unknown Facility
Porto Alegre, 90035-003, Brazil
Unknown Facility
Sao Jose Rio Preto, 15090-003, Brazil
Unknown Facility
São Luís, 78048-790, Brazil
Unknown Facility
São Paulo, 04023-900, Brazil
Unknown Facility
Créteil, 94010, France
Unknown Facility
Le Kremlin-Bicêtre, 94275, France
Unknown Facility
Marseille, 13385, France
Unknown Facility
Paris, 75747, France
Unknown Facility
Strasbourg, 67091, France
Unknown Facility
Toulouse, 31059, France
Unknown Facility
Athens, 11527, Greece
Unknown Facility
Nikaia, 18354, Greece
Unknown Facility
Medan, 20119, Indonesia
Unknown Facility
Cagliari, 09134, Italy
Unknown Facility
Istanbul, 34303, Turkey (Türkiye)
Unknown Facility
Istanbul, 34390, Turkey (Türkiye)
Unknown Facility
Istanbul, 34662, Turkey (Türkiye)
Unknown Facility
Izmir, 35040, Turkey (Türkiye)
Unknown Facility
Abu Dhabi, United Arab Emirates
Related Publications (1)
Prabhu AR, Rao IR, Nagaraju SP, Rajwar E, Venkatesh BT, Nair N S, Pai G, Reddy NP, Suvarna D. Interventions for dialysis patients with hepatitis C virus (HCV) infection. Cochrane Database Syst Rev. 2023 Apr 25;4(4):CD007003. doi: 10.1002/14651858.CD007003.pub3.
PMID: 37096802DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY CHAIR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2016
First Posted
June 20, 2016
Study Start
June 1, 2004
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
October 31, 2016
Results First Posted
October 31, 2016
Record last verified: 2016-09