A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis C and Chronic Renal Failure.

Hepatitis C, Chronic Clinical Trial

Official title:

An Open Label Study of the Effect of PEGASYS on Sustained Virological Response in Patients With Chronic Hepatitis C and Chronic Renal Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00474955
• Other study ID #: ML20434
• Status: Completed
• Phase: Phase 4
• First received: May 16, 2007
• Last updated: December 1, 2015
• Start date: July 2007
• Est. completion date: June 2011

Study information

• Verified date: December 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Federal Agency of drug quality control
• Study type: Interventional

Clinical Trial Summary

This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis C and end-stage renal disease, including patients on hemodialysis. Patients will receive PEGASYS at a dose of 180 micrograms weekly; those with a calculated glomerular filtration rate of <15mL/min will receive a reduced dose of 135 micrograms weekly. Following 48 weeks of treatment there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• adult patients, 18-60 years of age;

• chronic hepatitis C;

• chronic renal failure, including patients on hemodialysis therapy;

• detectable HCV RNA levels (>500IU/mL).

Exclusion Criteria:

• concurrent active hepatitis A or B;

• history or evidence of a medical condition associated with chronic liver disease other than HCV;

• history or other evidence of decompensated liver disease;

• therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment <=6 months prior to study;

• acute renal failure.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group 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

Intervention

Drug:
• peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 48 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with SVR		24 weeks after treatment completion	No
Primary	Percentage of patients with undetectable HCV-RNA		Week 24 and 48	No
Primary	Percentage of patients with a 2log10 drop in HCV-RNA		Week 24	No
Secondary	SAEs, premature withdrawals, AEs and laboratory parameters.		Throughout study	No