HELPS Study - A Study of Peginterferon Alfa-2a (Pegasys) in Patients With Chronic Hepatitis C (CHC) and End-Stage Renal Disease (ESRD)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT02806505
• Date of registration: 16/06/2016
• Prospective Registration: No
• Primary sponsor: Hoffmann-La Roche
• Public title: HELPS Study - A Study of Peginterferon Alfa-2a (Pegasys) in Patients With Chronic Hepatitis C (CHC) and End-Stage Renal Disease (ESRD)
• Scientific 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
• Date of first enrolment: June 2004
• Target sample size: 81
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02806505
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Austria, Brazil, France, Greece, Indonesia, Italy, Turkey, United Arab Emirates

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hepatitis C, Chronic

Intervention(s)

Drug: Peginterferon alfa-2a

Primary Outcome(s)

Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Treatment [Time Frame: 24 weeks after end of treatment (Week 72)]

Secondary Outcome(s)

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 [Time Frame: Weeks 12 and 24]

Percentage of Participants With Virological Response (Non-detectable Hepatitis C Virus-ribonucleic Acid [HCV RNA]) at End of Treatment (EOT) [Time Frame: EOT (Week 48)]

Secondary ID(s)

MV17149

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 31/10/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02806505