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

Hepatitis C, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02806505
• Other study ID #: MV17149
• Status: Completed
• Phase: Phase 3
• First received: June 16, 2016
• Last updated: June 16, 2016
• Start date: June 2004
• Est. completion date: December 2008

Study information

• Verified date: June 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Agency for Drug Safety (ANSM)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 2008
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Serum HCV RNA quantifiable at greater than (>) 600 IU/mL

• Liver biopsy consistent with chronic hepatitis C infection obtained within 2 years of enrolment

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Treatment		24 weeks after end of treatment (Week 72)	No
Secondary	Percentage of Participants With Virological Response (Non-detectable Hepatitis C virus-ribonucleic acid [HCV-RNA]) at End of Treatment (EOT)		EOT (Week 48)	No
Secondary	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	No