Phase 4
N=27
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis C and Chronic Renal Failure.
Hepatitis C, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT00474955 ↗Enrolled (actual)
27
Serious AEs
7.4%
Results posted
Jul 2016
Primary outcome: Primary: Percentage of Participants Achieving Sustained Virologic Response at 24 Weeks Following Treatment Completion — 55.6 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- peginterferon alfa-2a [Pegasys] (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Virologic Response at 24 Weeks Following Treatment Completion |
55.6 | — |
| PRIMARY Percentage of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid Level at Week 24 and Week 48 |
59.3; 48.1 | — |
| PRIMARY Percentage of Participants With At Least a 2log10 Drop in Hepatitis C Virus Ribonucleic Acid at Week 24 as Compared to Baseline |
33.3 | — |
| SECONDARY Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events |
10; 2 | — |
| SECONDARY Number of Participants Who Prematurely Withdrew From the Treatment Over a Period of 48 Weeks |
5; 2; 1 | — |
| SECONDARY Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks |
6; 5; 4; 4; 6; 8 | — |
| SECONDARY Mean Change From Baseline in Blood Pressure up to Week 72 |
-0.7; 0.6; -2.9; -1.3; -2.6; -3.7 | — |
| SECONDARY Mean Change From Baseline in Heart Rate up to Week 72 |
0.7; 1.5; 2.6; 1.1; 0.5; 1.3 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00474955). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.