HELPS Study - A Study of Peginterferon Alfa-2a (Pegasys) in Patients With Chronic Hepatitis C (CHC) and End-Stage Renal Disease (ESRD)
NCT ID: NCT02806505
Last Updated: 2016-10-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
81 participants
INTERVENTIONAL
2004-06-30
2007-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
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Graz, , Austria
Vienna, , Austria
Brasília, , Brazil
Porto Alegre, , Brazil
Sao Jose Rio Preto, , Brazil
São Luís, , Brazil
São Paulo, , Brazil
Créteil, , France
Le Kremlin-Bicêtre, , France
Marseille, , France
Paris, , France
Strasbourg, , France
Toulouse, , France
Athens, , Greece
Nikaia, , Greece
Medan, , Indonesia
Cagliari, , Italy
Istanbul, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Abu Dhabi, , United Arab Emirates
Countries
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References
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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.
Other Identifiers
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MV17149
Identifier Type: -
Identifier Source: org_study_id