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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biolex Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00593151
First received: January 2, 2008
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Biolex Therapeutics, Inc.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: January 2008
Study Completion Date: March 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593151

Locations
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
Study Director: Walker Long, MD Biolex Therapeutics, Inc.
  More Information

Publications:
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.)

Responsible Party: Biolex Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00593151     History of Changes
Other Study ID Numbers: S07-200-02-003
Study First Received: January 2, 2008
Last Updated: February 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Biolex Therapeutics, Inc.:
Antimetabolites
Virus Diseases
Anti-Infective Agents
RNA Virus Infections
Digestive System Diseases
Flaviviridae Infections
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Molecular Mechanisms of Action
Pharmacologic Actions

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Peginterferon alfa-2b
Reaferon
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014