Study of Safety, Tolerability, and Anti-Viral Effect of Locteron Compared to PEG-Intron in Patients With Chronic Hepatitis C
PLUS
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
1 other identifier
interventional
32
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2008
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 2, 2008
CompletedFirst Posted
Study publicly available on registry
January 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFebruary 3, 2012
February 1, 2012
11 months
January 2, 2008
February 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess in subjects with chronic hepatitis C the safety and tolerability of Locteron in comparison with PEG-Intron.
7 months (4 weeks of treatment, 6 months of follow up)
Secondary Outcomes (1)
To assess in subjects with chronic hepatitis C receiving a weight-based oral daily dose of ribavirin: • The PK profile of Locteron (IFNa2b) • The preliminary efficacy of Locteron assessed by serial quantitation of HCV RNA levels
4 weeks
Study Arms (3)
A, C, 320 mcg
EXPERIMENTALBi-weekly subcutaneous doses of Locteron (controlled-release interferon alpha 2b) with oral ribavirin.
B, C, 640 mcg
EXPERIMENTALBi-weekly subcutaneous doses of Locteron (controlled-release interferon alpha 2b) with oral ribavirin.
A, B, C PEG
ACTIVE COMPARATORWeekly subcutaneous injections of 1.5 ug/kg PegIntron (12 kDalton pegylated interferon alpha 2b) with oral ribavirin.
Interventions
biological+device, bi-weekly subcutaneous injections for 4-12 weeks, 160 mcg per injection
biological, weekly subcutaneous injections for 4-12 weeks, 1.5 mcg/kg
Eligibility Criteria
You may qualify if:
- Evidence of chronic hepatitis C
- Positive HCV RNA test with a level \>= 1 x 104 IU/mL (by RT-PCR)
You may not qualify if:
- Decompensated Liver Disease
- Positive test for serum antibodies to the human immunodeficiency virus (HIV), hepatitis A (HAV-IgM), o hepatitis B (HBV- +Hepatitis B surface antigen)
- A history of severe psychiatric disease, including major depression
- A history of immunologically-mediated disease, COPD, severe asthma, severe cardiac disease, active cancer or cancer within last 5 years, seizures within the past 5 years or epilepsy, solid organ or bone marrow transplant, uncontrolled thyroid disease, or clinically significant retinopathy
- Pregnant or lactating females
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Methodist Dallas Medical Center
Dallas, Texas, 75208, United States
Alamo Medical Research
San Antonio, Texas, 78215, United States
Inova Center for Liver Diseases
Annandale, Virginia, 22003, United States
McGuire DVAMC, McGuire Research Institute
Richmond, Virginia, 23249, United States
Related Publications (1)
Lawitz E, Younossi ZM, Shiffman M, Gordon S, Ghalib R, Long W, Muir A, McHutchison J. Randomized trial comparing systemic and local reactions to controlled-release interferon alpha2b and pegylated-interferon alpha2b in hepatitis C subjects who failed prior treatment. J Hepatology 50:S231 (abstract 628), 2009. (Presented to the 44th Annual Meeting Of The European Association for the Study of the Liver, April 22-26, 2009.)
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Walker Long, MD
Biolex Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2008
First Posted
January 14, 2008
Study Start
January 1, 2008
Primary Completion
December 1, 2008
Study Completion
March 1, 2009
Last Updated
February 3, 2012
Record last verified: 2012-02