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

January 11, 2016 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90045
    • Florida
      • Bradenton, Florida, United States, 34209
      • Orlando, Florida, United States, 32803
    • Georgia
      • Marietta, Georgia, United States, 30060
    • Massachusetts
      • Framingham, Massachusetts, United States, 01702
    • New Jersey
      • Newark, New Jersey, United States, 07102
      • Vineland, New Jersey, United States, 08360
    • New York
      • New York, New York, United States, 10016
      • Poughkeepsie, New York, United States, 12601
    • North Carolina
      • Asheville, North Carolina, United States, 28801
    • South Carolina
      • Columbia, South Carolina, United States, 29204
    • Texas
      • San Antonio, Texas, United States, 78215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 1

Peginterferon via auto-injector device.

All participants will receive Peginterferon in a cross-over design.
Device: Autoinjector
Participants received Peginterferon alfa-2a 180 microgram subcutaneously once a week by autoinjector for 3 weeks.
ACTIVE_COMPARATOR: 2

Peginterferon via pre-filled syringe.

All participants will receive Peginterferon in a cross-over design.
Device: Pre-filled syringe
Participants received Peginterferon alfa-2a 180 microgram subcutaneously once a week by pre-filled syringe for 3 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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?
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)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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.
Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)
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)
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%).
Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)
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)
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.
Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)
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)
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%).
Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)
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)
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%).
Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)
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)
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.
Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)
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)
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.
Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)
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)
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%).
Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)
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)
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.
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)
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)
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
Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)
Number of Participants With Adverse Events (AE)
Time Frame: Upto Day 36
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.
Upto Day 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NP25154

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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