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NCT01087944 · ClinicalTrials.gov registry record · Phase 1
A Study of Administration of Peginterferon Alfa-2a [Pegasys] by Autoinjector Versus Pre-filled Syringe in Patients With Chronic Hepatitis C
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT01087944 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 60 participants.
The verdict
NCT01087944, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Autoinjector
- DEVICE Pre-filled syringe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2010-03 |
| Est. Completion | 2010-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01087944
The ClinicalTrials.gov registry entry for NCT01087944 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Autoinjector is the first listed.
NCT01087944 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01087944 about?
NCT01087944 is a clinical study titled "A Study of Administration of Peginterferon Alfa-2a [Pegasys] by Autoinjector Versus Pre-filled Syringe in Patients With Chronic Hepatitis C". 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 treatme...
What is the current status of trial NCT01087944?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2010-03. Estimated completion is 2010-06.
What interventions are being tested in trial NCT01087944?
The interventions under investigation include: Autoinjector (DEVICE), Pre-filled syringe (DEVICE).
Who is sponsoring clinical trial NCT01087944?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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