Study of Safety, Tolerability, and Anti-Viral Effect of Locteron Compared to PEG-Intron in Patients With Chronic Hepatitis C
Public ClinicalTrials.gov record NCT00593151. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label, 3-Panel, Dose-Escalation Study to Assess the Safety and Tolerability, Pharmacokinetics, and Viral Kinetics of Two Doses of LocteronTM (Poly ActiveTM - Interferon Alpha 2b) Given Every 2 Weeks for 4-12 Weeks in Comparison With PEG-Intron Given Weekly for 4-12 Weeks in Patients With Chronic Hepatitis C
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purposes of the PLUS study were to confirm the safety and tolerability of two doses of LocteronTM (320 ug and 640 ug) dosed over four weeks in patients who had failed prior anti-HCV therapies (Panels A and B), and then to continue to study the safety, tolerability, and preliminary efficacy of the same two doses of LocteronTM (320 ug and 640 ug) in treatment-naïve genotype 1 HCV patients when Locteron dosed over 12 weeks (Panel C). All subjects were also to receive oral daily weight-based ribavirin.
Study identification
- NCT ID
- NCT00593151
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 32 participants
Conditions and interventions
Conditions
Interventions
- Locteron (controlled-release interferon alpha 2b) Other
- pegylated IFNa2b Biological
Other · Biological
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
- Dec 31, 2007
- Primary completion
- Nov 30, 2008
- Completion
- Feb 28, 2009
- Last update posted
- Feb 2, 2012
2008 – 2009
United States locations
- U.S. sites
- 5
- U.S. states
- 3
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Methodist Dallas Medical Center | Dallas | Texas | 75208 | — |
| Alamo Medical Research | San Antonio | Texas | 78215 | — |
| Inova Center for Liver Diseases | Annandale | Virginia | 22003 | — |
| McGuire DVAMC, McGuire Research Institute | Richmond | Virginia | 23249 | — |
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 NCT00593151, 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 2, 2012 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00593151 live on ClinicalTrials.gov.