Clinical trial NCT02806505: HELPS Study - A Study of Peginterferon Alfa-2a (Pegasys) in Patients With Chronic Hepatitis C (CHC) and End-Stage Renal Disease (ESRD)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-06-20
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Treatment
timeFrame: 24 weeks after end of treatment (Week 72)
Secondary outcomes:
measure: Percentage of Participants With Virological Response (Non-detectable Hepatitis C Virus-ribonucleic Acid [HCV RNA]) at End of Treatment (EOT)
timeFrame: EOT (Week 48)
measure: 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
timeFrame: Weeks 12 and 24
Other outcomes:
Locations:
city: Graz
country: Austria
city: Wien
country: Austria
city: Brasilia
country: Brazil
city: Porto Alegre
country: Brazil
city: Sao Jose Rio Preto
country: Brazil
city: Sao Luis
country: Brazil
city: Sao Paulo
country: Brazil
city: Creteil
country: France
city: Le Kremlin-bicetre
country: France
city: Marseille
country: France
city: Paris
country: France
city: Strasbourg
country: France
city: Toulouse
country: France
city: Athens
country: Greece
city: Nikea
country: Greece
city: Medan
country: Indonesia
city: Cagliari
country: Italy
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Abu Dhabi
country: United Arab Emirates
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: