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

Roche

Status and phase: Completed; Phase 4

Conditions: Hepatitis C, Chronic

Treatments: Drug: peginterferon alfa-2a [Pegasys]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00474955

ML20434

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Peginterferon Alpha-2a

Experimental group

Description:

Eligible participants will be administered peginterferon alpha-2a \[Pegasys\] (40 kilo Dalton), 180 micrograms as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated glomerular filtration rate of \<15 milliliter /minute will be administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.

Treatment:

Drug: peginterferon alfa-2a [Pegasys]