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

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ClinicalTrials.gov Identifier: NCT00474955
Recruitment Status : Completed
First Posted : May 17, 2007
Results First Posted : July 25, 2016
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE May 16, 2007
First Posted Date  ICMJE May 17, 2007
Results First Submitted Date  ICMJE April 22, 2016
Results First Posted Date  ICMJE July 25, 2016
Last Update Posted Date July 25, 2016
Study Start Date  ICMJE July 2007
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
  • 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).
  • 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.
  • 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]).
Original Primary Outcome Measures  ICMJE
 (submitted: May 16, 2007)
Percentage of patients with sustained virological response 24 weeks after treatment completion; percentage with undetectable HCV-RNA at week 24, and week 48; percentage with a 2 log10 drop of HCV-RNA at week 24.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
  • 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
  • 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.
  • 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).
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2007)
SAEs, premature withdrawals, clinically significant AEs and laboratory abnormalities.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis C and Chronic Renal Failure.
Official Title  ICMJE Multicenter Open-label Observation Program in Patients With Chronic Hepatitis C and With Chronic Renal Failure (CRF) Receiving Peginterferon Alpha-2a (40 kDa) Pegasys
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C, Chronic
Intervention  ICMJE Drug: peginterferon alfa-2a [Pegasys]
180 micrograms or 135 micrograms sc weekly for 48 weeks
Study Arms  ICMJE 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.
Intervention: Drug: peginterferon alfa-2a [Pegasys]
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 24, 2012)
27
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00474955
Other Study ID Numbers  ICMJE ML20434
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP