A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis C and Chronic Renal Failure.
- Conditions
- Hepatitis C, Chronic
- Interventions
- Drug: peginterferon alfa-2a [Pegasys]
- Registration Number
- NCT00474955
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
- adult patients, 18-60 years of age;
- chronic hepatitis C;
- chronic renal failure, including patients on hemodialysis therapy;
- detectable HCV RNA levels (>500IU/mL).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Peginterferon Alpha-2a peginterferon alfa-2a [Pegasys] 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Sustained Virologic Response at 24 Weeks Following Treatment Completion At Week 72 Sustained virologic response is defined as undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels (\<50 international units \[IU\]/mL) at 24 weeks following the completion of 48 weeks treatment period (Week 72).
Percentage of Participants With At Least a 2log10 Drop in Hepatitis C Virus Ribonucleic Acid at Week 24 as Compared to Baseline From Baseline (Days -30 to -1) and Week 24 The table below shows the percentage of participants with at least 2log10 drop in HCV RNA level at Week 24 as compared to Baseline (Screening visit \[Days -30 to -1\]).
Percentage of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid Level at Week 24 and Week 48 At Week 24 and Week 48 HCV RNA level less than 50 IU/mL was considered to be undetectable.
- Secondary Outcome Measures
Name Time Method Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks Up to Week 72 Marked abnormal laboratory parameters included serum glutamic pyruvic transaminase (SGPT), serum glutamic oxaloacetic transaminase (SGOT), gamma-glutamyl transpeptidase (GGTP), total bilirubin, alkaline phosphatase (ALP), ferritin and transferrin saturation. These laboratory parameters were evaluated at Baseline (Screening visit \[Days -30 to -1\]) and at various Visits (V): Week 0 (V1), Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7) and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10).
Mean Change From Baseline in Heart Rate up to Week 72 From Baseline (Days -30 to -1) to Week 72 Mean change from baseline in heart rate was recorded at Baseline (Screening visit \[Days -30 to -1\]), and at various Visits (V): Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7), and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10).
Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events Up to Week 72 An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect
Number of Participants Who Prematurely Withdrew From the Treatment Over a Period of 48 Weeks Up to Week 48 Participants who prematurely withdrew from the treatment for the following reasons: personal reasons (not related to the study), adverse events, and drug unavailability, are presented.
Mean Change From Baseline in Blood Pressure up to Week 72 From Baseline (Days -30 to -1) to Week 72 Mean change from Baseline in diastolic blood pressure (DBP) and systolic blood pressure (SBP) was recorded at Baseline (Screening visit \[Days -30 to -1\]) and at various Visits (V): Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7) and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10).