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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00474955
First received: May 16, 2007
Last updated: June 14, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention Phase
Hepatitis C, Chronic
Drug: peginterferon alfa-2a [Pegasys]
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants Achieving Sustained Virologic Response at 24 Weeks Following Treatment Completion [ Time Frame: At Week 72 ] [ Designated as safety issue: No ]
    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 Undetectable Hepatitis C Virus Ribonucleic Acid Level at Week 24 and Week 48 [ Time Frame: At Week 24 and Week 48 ] [ Designated as safety issue: No ]
    HCV RNA level less than 50 IU/mL was considered to be undetectable.

  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events [ Time Frame: Up to Week 72 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to Week 48 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks [ Time Frame: Up to Week 72 ] [ Designated as safety issue: No ]
    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 Blood Pressure up to Week 72 [ Time Frame: From Baseline (Days -30 to -1) to Week 72 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in Heart Rate up to Week 72 [ Time Frame: From Baseline (Days -30 to -1) to Week 72 ] [ Designated as safety issue: No ]
    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).


Enrollment: 27
Study Start Date: July 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474955

Locations
Russian Federation
Chita, Russian Federation, 672090
Irkutsk, Russian Federation, 664047
Khabarovsk, Russian Federation, 680009
Khabarovsk, Russian Federation, 680022
Orenburg, Russian Federation, 460040
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00474955     History of Changes
Other Study ID Numbers: ML20434 
Study First Received: May 16, 2007
Results First Received: April 22, 2016
Last Updated: June 14, 2016
Health Authority: Russia: Federal Agency of drug quality control

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 28, 2016