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Trial record 5 of 1135 for:    IFNA2 AND Antiviral Agents

Study of Safety, Tolerability, and Anti-Viral Effect of Locteron Compared to PEG-Intron in Patients With Chronic Hepatitis C (PLUS)

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ClinicalTrials.gov Identifier: NCT00593151
Recruitment Status : Completed
First Posted : January 14, 2008
Last Update Posted : February 3, 2012
Sponsor:
Information provided by (Responsible Party):
Biolex Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Other: Locteron (controlled-release interferon alpha 2b) Biological: pegylated IFNa2b Phase 1 Phase 2

Detailed Description:
Panels A and B of the PLUS study were designed to assess the safety and tolerability, pharmacokinetics, and viral kinetics over four weeks of two doses of Locteron™ (230 ug and 640 ug) given every two weeks in comparison with PegIntron® given weekly in treatment-experienced subjects with chronic hepatitis C of any genotype who were co-administered weight-based oral ribavirin. The two cohorts of 16 subjects each in Panels A and B consisted of subjects who had failed prior interferon therapy. In Panel A, 8 subjects were randomized to and completed 4 weeks of treatment with 320 μg Locteron™ and 8 subjects were randomized to and completed 4 weeks of treatment with 1.5 ug/kg PegIntron®. In Panel B, 8 subjects were randomized to and completed 4 weeks of treatment with 640 μg Locteron™ and 8 subjects were randomized to and completed 4 weeks of treatment with 1.5 ug/kg PegIntron®. When the results of Panel A and Panel B were known, conduct of Panel C for 12 weeks in treatment-naive patients with chronic genotype-1 HCV was considered unnecessary and cancelled, and an entirely new study was begun instead.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A, C, 320 mcg
Bi-weekly subcutaneous doses of Locteron (controlled-release interferon alpha 2b) with oral ribavirin.
Other: Locteron (controlled-release interferon alpha 2b)
biological+device, bi-weekly subcutaneous injections for 4-12 weeks, 160 mcg per injection
Other Names:
  • PolyActive-IFNa2b
  • BLX-883+PolyActive

Experimental: B, C, 640 mcg
Bi-weekly subcutaneous doses of Locteron (controlled-release interferon alpha 2b) with oral ribavirin.
Other: Locteron (controlled-release interferon alpha 2b)
biological+device, bi-weekly subcutaneous injections for 4-12 weeks, 160 mcg per injection
Other Names:
  • PolyActive-IFNa2b
  • BLX-883+PolyActive

Active Comparator: A, B, C PEG
Weekly subcutaneous injections of 1.5 ug/kg PegIntron (12 kDalton pegylated interferon alpha 2b) with oral ribavirin.
Biological: pegylated IFNa2b
biological, weekly subcutaneous injections for 4-12 weeks, 1.5 mcg/kg
Other Names:
  • PEG-Intron
  • PEG
  • 12 kDalton pegylated interferon alpha 2b




Primary Outcome Measures :
  1. To assess in subjects with chronic hepatitis C the safety and tolerability of Locteron in comparison with PEG-Intron. [ Time Frame: 7 months (4 weeks of treatment, 6 months of follow up) ]

Secondary Outcome Measures :
  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 [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Evidence of chronic hepatitis C
  • Positive HCV RNA test with a level >= 1 x 104 IU/mL (by RT-PCR)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593151


Locations
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United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Texas
Methodist Dallas Medical Center
Dallas, Texas, United States, 75208
Alamo Medical Research
San Antonio, Texas, United States, 78215
United States, Virginia
Inova Center for Liver Diseases
Annandale, Virginia, United States, 22003
McGuire DVAMC, McGuire Research Institute
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
Biolex Therapeutics, Inc.
Investigators
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Study Director: Walker Long, MD Biolex Therapeutics, Inc.

Publications of Results:
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.)

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Responsible Party: Biolex Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00593151     History of Changes
Other Study ID Numbers: S07-200-02-003
First Posted: January 14, 2008    Key Record Dates
Last Update Posted: February 3, 2012
Last Verified: February 2012
Keywords provided by Biolex Therapeutics, Inc.:
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Antimetabolites
Virus Diseases
RNA Virus Infections
Digestive System Diseases
Flaviviridae Infections
Therapeutic Uses
Molecular Mechanisms of Action
Pharmacologic Actions
Additional relevant MeSH terms:
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Interferon-alpha
Interferon alpha-2
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Physiological Effects of Drugs
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Interferons
Peginterferon alfa-2b
Immunologic Factors