A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis C and Chronic Renal Failure.

Multicenter Open-label Observation Program in Patients With Chronic Hepatitis C and With Chronic Renal Failure (CRF) Receiving Peginterferon Alpha-2a (40 kDa) Pegasys

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C, Chronic
• Intervention / Treatment: Drug: peginterferon alfa-2a [Pegasys]

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 4

Contacts and Locations

Study Locations

• Russian Federation
  • Chita, Russian Federation, 672090
  • Irkutsk, Russian Federation, 664047
  • Khabarovsk, Russian Federation, 680009
  • Khabarovsk, Russian Federation, 680022
  • Orenburg, Russian Federation, 460040

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peginterferon Alpha-2a; 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.	Drug: peginterferon alfa-2a [Pegasys]; 180 micrograms or 135 micrograms sc weekly for 48 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Sustained Virologic Response at 24 Weeks Following Treatment Completion	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).	At Week 72
Percentage of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid Level at Week 24 and Week 48	HCV RNA level less than 50 IU/mL was considered to be undetectable.	At Week 24 and Week 48
Percentage of Participants With At Least a 2log10 Drop in Hepatitis C Virus Ribonucleic Acid at Week 24 as Compared to Baseline	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]).	From Baseline (Days -30 to -1) and Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events	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	Up to Week 72
Number of Participants Who Prematurely Withdrew From the Treatment Over a Period of 48 Weeks	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.	Up to Week 48
Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks	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).	Up to Week 72
Mean Change From Baseline in Blood Pressure up 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).	From Baseline (Days -30 to -1) to Week 72
Mean Change From Baseline in Heart Rate up 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).	From Baseline (Days -30 to -1) to Week 72

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: May 16, 2007
• First Submitted That Met QC Criteria: May 16, 2007
• First Posted (Estimate): May 17, 2007

Study Record Updates

• Last Update Posted (Estimate): July 25, 2016
• Last Update Submitted That Met QC Criteria: June 14, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Kidney Diseases; Urologic Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Renal Insufficiency, Chronic; Hepatitis; Hepatitis A; Hepatitis C; Kidney Failure, Chronic; Renal Insufficiency; Hepatitis C, Chronic; Anti-Infective Agents; Antiviral Agents; Peginterferon alfa-2a
• Other Study ID Numbers: ML20434