Clinical trial NCT00474955: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis C and Chronic Renal Failure.
Official title: Multicenter Open-label Observation Program in Patients With Chronic Hepatitis C and With Chronic Renal Failure (CRF) Receiving Peginterferon Alpha-2a (40 kDa) Pegasys
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-05-17
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants Achieving Sustained Virologic Response at 24 Weeks Following Treatment Completion
timeFrame: At Week 72
measure: Percentage of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid Level at Week 24 and Week 48
timeFrame: At Week 24 and Week 48
measure: Percentage of Participants With At Least a 2log10 Drop in Hepatitis C Virus Ribonucleic Acid at Week 24 as Compared to Baseline
timeFrame: From Baseline (Days -30 to -1) and Week 24
Secondary outcomes:
measure: Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events
timeFrame: Up to Week 72
measure: Number of Participants Who Prematurely Withdrew From the Treatment Over a Period of 48 Weeks
timeFrame: Up to Week 48
measure: Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
timeFrame: Up to Week 72
measure: Mean Change From Baseline in Blood Pressure up to Week 72
timeFrame: From Baseline (Days -30 to -1) to Week 72
measure: Mean Change From Baseline in Heart Rate up to Week 72
timeFrame: From Baseline (Days -30 to -1) to Week 72
Other outcomes:
Locations:
city: Chita
country: Russian Federation
city: Irkutsk
country: Russian Federation
city: Khabarovsk
country: Russian Federation
city: Khabarovsk
country: Russian Federation
city: Orenburg
country: Russian Federation
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: