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Completed Phase 1 Interventional Results available

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

ClinicalTrials.gov ID: NCT01087944

Public ClinicalTrials.gov record NCT01087944. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 10, 2026, 5:16 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Tolerability and User Handling Study of an Autoinjector to Administer 180 µg/0.5 mL Peginterferon Alfa-2a (Pegasys, PEG-IFN)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01087944
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
60 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 28, 2010
Primary completion
May 31, 2010
Completion
May 31, 2010
Last update posted
Feb 8, 2016

2010

United States locations

U.S. sites
12
U.S. states
9
U.S. cities
12
Facility City State ZIP Site status
Not listed Los Angeles California 90045
Not listed Bradenton Florida 34209
Not listed Orlando Florida 32803
Not listed Marietta Georgia 30060
Not listed Framingham Massachusetts 01702
Not listed Newark New Jersey 07102
Not listed Vineland New Jersey 08360
Not listed New York New York 10016
Not listed Poughkeepsie New York 12601
Not listed Asheville North Carolina 28801
Not listed Columbia South Carolina 29204
Not listed San Antonio Texas 78215

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01087944, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 8, 2016 · Synced Sep 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01087944 live on ClinicalTrials.gov.

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