Trial information
A Study of PEGASYS (Peginterferon alfa-2a (40KD)) in Patients With Chronic Hepatitis C and Chronic Renal Failure.
Status: Recruiting
Protocol number: ML20434
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study of the effect of PEGASYS on sustained virological response in patients with chronic hepatitis C and chronic renal failure
Brief 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. Target sample size is 150.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD) [PEGASYS]
Primary outcome: 1. Percentage of patients with SVR Time frame: 24 weeks after treatment completion
2. Percentage of patients with undetectable HCV-RNA Time frame: Week 24 and 48
3. Percentage of patients with a 2log10 drop in HCV-RNA Time frame: Week 24
Key secondary outcomes: 1. SAEs, premature withdrawals, AEs and laboratory parameters. Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: 60 Years
Accepts healthy volunteers: No
Trial registration date: 05/17/2007
Date last updated: 8/29/2008
Link to trial result
This trial is being conducted at the following locations:
Russian Federation
- Chelyabinsk
- Chita
- Ekaterinburg
- Irkutsk
- Khabarovsk
- Krasnodar
- Moscow
- St Petersburg
