Trial information
HELPS study - A Study of PEGASYS (Peginterferon alfa-2a (40KD)) in Patients With Chronic Hepatitis C (CHC) and End-Stage Renal Disease
Status: Completed
Protocol number: MV17149
Sponsor: F Hoffmann-La Roche Ltd./Inc/AG/Roche Global Business
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of two different dosages of PEGASYS monotherapy on sustained virologic response in hemodialysis patients with chronic hepatitis C and end-stage renal disease
Brief summary: This study will evaluate the safety and efficacy of PEGASYS monotherapy in patients with CHC who have end-stage renal disease (ESRD) and are undergoing hemodialysis. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
Target sample size is
110.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Placebo; Parallel; Safety/Efficacy study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD)[PEGASYS]
Primary outcome: 1. Efficacy: Sustained virologic response rate 24 weeks post- treatment
Key secondary outcomes: 1. Efficacy: Percentage of patients with non-detectable HCV-RNA at Wks 12, 24, and EOT, % of patients with at least a 2 log drop of HCV-RNA at Wks 12 and 24
Safety: AE rate/profile, lab values, vital signs
Inclusion criteria:
- adult patients 18-65 years of age;
- CHC infection;
- liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection;
- ESRD and undergoing hemodialysis for >=2 months before first dose of study drug;
- use of 2 forms of contraception during study and 6 months after the study in both men and women.
Exclusion criteria:
- women who are pregnant or breastfeeding;
- male partners of women who are pregnant;
- conditions associated with decompensated liver disease;
- other forms of liver disease, including liver cancer;
- human immunodeficiency virus infection.
Gender: Males or Females
Age limits: Min: 18 Years Max: 65 Years
Accepts healthy volunteers: No
Anticipated start date: June, 2004
Trial registration date: 07/26/2005
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Austria
Brazil
- Porto Alegre
- Sao Jose do Rio Preto
- Sao Luis
- Sao Paulo
France
- Creteil
- Le Kremlin-Bicetre
- Marseille
- Paris
- Strasbourg
- Toulouse
Greece
Indonesia
Italy
Turkey
United Arab Emirates
