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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
Results First Received: November 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis C, Chronic
Interventions: Device: Autoinjector
Device: Pre-filled syringe

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 60 participant’s data were included from USA (10 centers). The inclusion period was between 11th March 2010 and 28th May 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This was a two-arm, randomized, crossover study in adult participants with hepatitis C infection. Participants were randomly assigned to one of two groups, in which they received injections by either pre-filled syringe (PFS) or autoinjector (AI) for the first 3 weeks and then switched to the other injection method for an additional 3 weeks.

Reporting Groups
  Description
Sequence 1 (Auto-Injector Then Pre-filled Syringe) Participants received Peginterferon alfa-2a (PEG-IFN) 180 microgram (mcg) /0.5 milliliter (mL) subcutaneously once a week using autoinjector from Week 1-3 in Treatment Period 1 and using pre-filled syringe from Week 4-6 in Treatment Period 2.
Sequence 2 (Pre-filled Syringe Then Auto-Injector) Participants received PEG-IFN 180 mcg /0.5 mL subcutaneously once a week using pre-filled syringe from Week 1-3 in Treatment Period 1 and using autoinjector from Week 4-6 in Treatment Period 2.

Participant Flow for 2 periods

Period 1:   Period 1 (Week 1-3)
    Sequence 1 (Auto-Injector Then Pre-filled Syringe)     Sequence 2 (Pre-filled Syringe Then Auto-Injector)  
STARTED     30     30  
COMPLETED     29     30  
NOT COMPLETED     1     0  
Adverse Event                 1                 0  

Period 2:   Period 2 (Week 4-6)
    Sequence 1 (Auto-Injector Then Pre-filled Syringe)     Sequence 2 (Pre-filled Syringe Then Auto-Injector)  
STARTED     29     30  
COMPLETED     29     28  
NOT COMPLETED     0     2  
Adverse Event                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat (ITT) population included all participants who received at least one injection.

Reporting Groups
  Description
Overall Participants received PEG-IFN alfa-2a 180 mcg SC once a week either AI or PFS for the first 3 weeks and then switched to the other method of injection for an additional 3 weeks. Participants also received ribavirin according to standard of care per the investigator’s judgment.

Baseline Measures
    Overall  
Number of Participants  
[units: participants]
  60  
Age  
[units: Years]
Mean (Standard Deviation)
  49.5  (10.60)  
Gender  
[units: participants]
 
Female     29  
Male     31  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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) ]

2.  Secondary:   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) ]

3.  Secondary:   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) ]

4.  Secondary:   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) ]

5.  Secondary:   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) ]

6.  Secondary:   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) ]

7.  Secondary:   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) ]

8.  Secondary:   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) ]

9.  Secondary:   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) ]

10.  Secondary:   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) ]

11.  Secondary:   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) ]

12.  Secondary:   Number of Participants With Adverse Events (AE)   [ Time Frame: Upto Day 36 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
phone: +41 61 6878333
e-mail: global.trial_information@roche.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01087944     History of Changes
Other Study ID Numbers: NP25154
Study First Received: March 9, 2010
Results First Received: November 17, 2015
Last Updated: January 11, 2016
Health Authority: United States: Food and Drug Administration