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A Study of Administration of Peginterferon Alfa-2a [Pegasys] by Autoinjector Versus Pre-filled Syringe in Patients With Chronic Hepatitis C

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01087944
First received: March 9, 2010
Last updated: January 11, 2016
Last verified: January 2016

March 9, 2010
January 11, 2016
March 2010
June 2010   (final data collection date for primary outcome measure)
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector [ Time Frame: Week 1, Day 1 (Baseline), Week 2 (Day 8 ± 2 days), Week 3 (Day 15 ± 2 days), Week 4 (Day 22 ± 2 days), Week 5 (Day 29 ± 2 days), Week 6 (Day 36 ± 2 days) ] [ Designated as safety issue: No ]
The feasibility of PEG-INF administration by AI was assessed by Injection Method Observational Survey questions, based on following pre-defined questions using a "Yes" or "No" response: 1) Did the participant exhibit any nervousness prior to the injection? 2) Did the participant exhibit any difficulty initiating the injection? 3) Did the participant appear confident performing the injection? 4) Did the participant follow the instructions for performing the injection without the need for additional instructions or guidance? 5) Did the participant experience any technical problems with the device or syringe during the injection? 6) Did the participant withdraw the device/syringe before the injection was complete? 7) Did the participant exhibit any visible pain or physical discomfort? 8) Did the participant appear to be satisfied using the device or syringe? 9) Did the participant exhibit any frustration using the syringe or device?
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector [ Time Frame: assessed weekly at time of injection ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01087944 on ClinicalTrials.gov Archive Site
  • Number of Participants With Marked Laboratory Abnormalities in Hemoglobin, Albumin and Total Protein [ Time Frame: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days) ] [ Designated as safety issue: Yes ]
    A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for hemoglobin was 110-200 (gram per liter [g/L]), albumin was 30.0-n.d g/L, and total protein was 55-87 g/L. The clinical relevant change (decrease/ increase) for hemoglobin was (15%, 15%), albumin was (20%, n.d) and total protein was (20%, 20%) respectively.
  • Number of Participants With Marked Laboratory Abnormalities in Hematocrit [ Time Frame: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days) ] [ Designated as safety issue: Yes ]
    A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for hematocrit was 0.31-0.56 fraction. The clinical relevant change (decrease/ increase) for hematocrit was (15%, 15%).
  • Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil [ Time Frame: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days) ] [ Designated as safety issue: Yes ]
    A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for Platelets was 100-550 (10*9/L), for WBC was 3.0-18.0 (10*9/L), for Basophils was 0.00-0.40 (10*9/L), for Eosinophil was 0.00-0.90 (10*9/L), for Lymphocytes was 0.70-7.60 (10*9/L), Monocyte was 0.00-1.70 (10*9/L), and Neutrophil 1.50-9.25 (10*9/L). The clinical relevant change (decrease/increase) for platelet was (30%, 50%), WBC was (30%, 30%), Basophil was (n.d, 100%), Eosinophil was (n.d, 100%), Lymphocyte was (30%, 30%), Monocyte was (n.d, 100%) and Neutrophil was (20%, 20%) respectively.
  • Number of Participants With Marked Laboratory Abnormalities in Right Blood Cell (RBC) [ Time Frame: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days) ] [ Designated as safety issue: Yes ]
    A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for RBC was 3.80-6.10 (10*12/L). The clinical relevant change (decrease/ increase) for RBC was (15%, 15%).
  • Number of Participants With Marked Laboratory Abnormalities in Prothrombin Time (PT) International Normalized Ratio (INR) [ Time Frame: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days) ] [ Designated as safety issue: Yes ]
    A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for PT-INR was n.d.-2.00. The clinical relevant change (decrease/ increase) for PT-INR was (n.d, 30%).
  • Number of Participants With Marked Laboratory Abnormalities in Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic-Pyruvic Transaminase (SGPT), and Alkaline Phosphatase [ Time Frame: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days) ] [ Designated as safety issue: Yes ]
    A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for SGOT was 0-80 (Units Per Litre [U/L]), SGPT was 0-110 U/L, and alkaline phosphatase was 0-220 U/L. The clinical relevant change (decrease/ increase) for SGOT was (n.d, 50%), SGPT was (n.d, 50%), and ALP was (n.d, 50%) respectively.
  • Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose [ Time Frame: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days) ] [ Designated as safety issue: Yes ]
    A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for BUN was 0.0-14.3 (millimoles per Liter [mmol/L]), Chloride was 95-115 (mmol/L), Potassium was 2.9-5.8 (mmol/L), Sodium was 130-150 (mmol/L), Calcium was 2.00-2.90 (mmol/L), and Glucose was 2.80-11.10 (mmol/L). The clinical relevant change (decrease/ increase) for BUN was (n.d, 50%), Chloride was (7%, 7%), Potassium was (20%, 20%), Sodium was (7%, 7%), Calcium was (10%, 10%), and Glucose was (75%, 75%) respectively.
  • Number of Participants With Marked Laboratory Abnormalities in Creatinine [ Time Frame: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days) ] [ Designated as safety issue: Yes ]
    A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for Creatinine was 0- 154 (micromoles/liter [umol/L]). The clinical relevant change (decrease/ increase) for Creatinine was (n.d, 50%).
  • Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure [ Time Frame: Week 1, Day 1 (Baseline), Week 2 (Day 8 ± 2 days), Week 3 (Day 15 ± 2 days), Week 4 (Day 22 ± 2 days), Week 5 (Day 29 ± 2 days), Week 6 (Day 36 ± 2 days) ] [ Designated as safety issue: Yes ]
    The pulse rate, temperature and blood pressure was assessed during a physical examination. Pulse rate was assessed in beats per minute (bpm), temperature was assessed in degree Celsius (°С), and blood pressure was assessed in millimeters of mercury (mmHg). Vital signs were taken while the participant was supine.
  • Number of Participants With Abnormalities in Electrocardiograms [ Time Frame: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days) ] [ Designated as safety issue: Yes ]
    A 12-lead ECG was recorded after the participant had been in a semi-supine position for at least 10 minutes. Any clinically significant abnormalities noted on an ECG after the first dose of study drug were captured as AEs
  • Number of Participants With Adverse Events (AE) [ Time Frame: Upto Day 36 ] [ Designated as safety issue: Yes ]
    An AE is defined as 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.
  • Safety and tolerability: Adverse events, laboratory parameters, ECG [ Time Frame: throughout study, laboratory assessments and ECG weeks 1, 4 and 6 ] [ Designated as safety issue: No ]
  • ease of handling of autoinjector versus pre-filled syringe, assessed by staff and patient [ Time Frame: weekly at time of injection ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Administration of Peginterferon Alfa-2a [Pegasys] by Autoinjector Versus Pre-filled Syringe in Patients With Chronic Hepatitis C
Tolerability and User Handling Study of an Autoinjector to Administer 180 µg/0.5 mL Peginterferon Alfa-2a (Pegasys, PEG-IFN)
This randomized, cross-over, open label study will compare the tolerability and handling of application of peginterferon alfa-2a [Pegasys] by autoinjector versus pre-filled syringe in patients with chronic hepatitis C, either on treatment with peginterferon alfa-2a for at least 12 weeks or treatment-naïve for peginterferon alfa-2a. Patients will be randomized to self-injection of 180mcg peginterferon alfa-2a once a week using either an autoinjector or a prefilled syringe for 3 weeks, then switch to use the other method of injection for another 3 weeks. Anticipated time on study treatment is 6 weeks. Target sample size is <100 patients.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Device: Autoinjector
    Participants received Peginterferon alfa-2a 180 microgram subcutaneously once a week by autoinjector for 3 weeks.
  • Device: Pre-filled syringe
    Participants received Peginterferon alfa-2a 180 microgram subcutaneously once a week by pre-filled syringe for 3 weeks.
  • Experimental: 1

    Peginterferon via auto-injector device.

    All participants will receive Peginterferon in a cross-over design.

    Intervention: Device: Autoinjector
  • Active Comparator: 2

    Peginterferon via pre-filled syringe.

    All participants will receive Peginterferon in a cross-over design.

    Intervention: Device: Pre-filled syringe
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >/=18 years of age
  • chronic hepatitis C
  • on treatment with peginterferon alfa-2a for >/= 12 weeks at baseline, or treatment-naïve for peginterferon alfa-2a

Exclusion Criteria:

  • history or evidence of decompensated liver disease
  • autoimmune hepatitis
  • hypersensitivity to peginterferon alfa-2a or any of its components
  • concomitant treatment that requires administration by self-injection, or prior use of an autoinjector
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01087944
NP25154
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
January 2016

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