NCT01087944

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 16, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

February 9, 2016

Completed
Last Updated

February 9, 2016

Status Verified

January 1, 2016

Enrollment Period

3 months

First QC Date

March 9, 2010

Results QC Date

November 17, 2015

Last Update Submit

January 11, 2016

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

  • Feasibility of Peginterferon Alfa-2a Administration by Autoinjector

    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 Outcomes (11)

  • Number of Participants With Marked Laboratory Abnormalities in Hemoglobin, Albumin and Total Protein

    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

    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

    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)

    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)

    Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)

  • +6 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Peginterferon via auto-injector device. All participants will receive Peginterferon in a cross-over design.

Device: Autoinjector

2

ACTIVE COMPARATOR

Peginterferon via pre-filled syringe. All participants will receive Peginterferon in a cross-over design.

Device: Pre-filled syringe

Interventions

AutoinjectorDEVICE

Participants received Peginterferon alfa-2a 180 microgram subcutaneously once a week by autoinjector for 3 weeks.

1
Pre-filled syringeDEVICE

Participants received Peginterferon alfa-2a 180 microgram subcutaneously once a week by pre-filled syringe for 3 weeks.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Los Angeles, California, 90045, United States

Location

Unknown Facility

Bradenton, Florida, 34209, United States

Location

Unknown Facility

Orlando, Florida, 32803, United States

Location

Unknown Facility

Marietta, Georgia, 30060, United States

Location

Unknown Facility

Framingham, Massachusetts, 01702, United States

Location

Unknown Facility

Newark, New Jersey, 07102, United States

Location

Unknown Facility

Vineland, New Jersey, 08360, United States

Location

Unknown Facility

New York, New York, 10016, United States

Location

Unknown Facility

Poughkeepsie, New York, 12601, United States

Location

Unknown Facility

Asheville, North Carolina, 28801, United States

Location

Unknown Facility

Columbia, South Carolina, 29204, United States

Location

Unknown Facility

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Roche Trial Information Hotline
Organization
F. Hoffmann-La Roche AG
global.trial_information@roche.com
+41 61 6878333

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2010

First Posted

March 16, 2010

Study Start

March 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

February 9, 2016

Results First Posted

February 9, 2016

Record last verified: 2016-01

Locations

US(12)