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Completed

NCT Number: NCT00474955

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

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.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chita, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

peginterferon alfa-2a [Pegasys]

Drug

180 micrograms or 135 micrograms sc weekly for 48 weeks

Primary outcomes

  1. Percentage of Participants Achieving Sustained Virologic Response at 24 Weeks Following Treatment Completion

    Time frame: 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).

  2. Percentage of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid Level at Week 24 and Week 48

    Time frame: At Week 24 and Week 48

    HCV RNA level less than 50 IU/mL was considered to be undetectable.

  3. Percentage of Participants With At Least a 2log10 Drop in Hepatitis C Virus Ribonucleic Acid at Week 24 as Compared to Baseline

    Time frame: 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]).

Secondary outcomes

  1. Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events

    Time frame: 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

  2. Number of Participants Who Prematurely Withdrew From the Treatment Over a Period of 48 Weeks

    Time frame: 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.

  3. Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks

    Time frame: 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).

  4. Mean Change From Baseline in Blood Pressure up to Week 72

    Time frame: 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).

  5. Mean Change From Baseline in Heart Rate up to Week 72

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
May 17, 2007
Registry last updated
Jul 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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