Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 (Immunomodulatory Oligonucleotide) in Hepatitis C-infected Patients
NCT ID: NCT00728936
Last Updated: 2019-02-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
58 participants
INTERVENTIONAL
2007-09-30
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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IMO-2125 0.04 mg/kg q week
IMO-2125 given weekly at 0.04 mg/kg
IMO-2125
IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system
IMO-2125 0.08 mg/kg q week
IMO-2125 given weekly at 0.08 mg/kg
IMO-2125
IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system
IMO-2125 0.16 mg/kg q week
IMO-2125 given weekly at 0.16 mg/kg
IMO-2125
IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system
IMO-2125 0.32 mg/kg q week
IMO-2125 given weekly at 0.32 mg/kg
IMO-2125
IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system
IMO-2125 0.48 mg/kg q week
IMO-2125 given weekly at 0.48 mg/kg
IMO-2125
IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system
Placebo
Weekly saline placebo
Saline placebo
saline placebo given subcutaneously
IMO-2125 0.16 mg/kg twice a week
IMO-2125 given twice a week at 0.16 mg/kg
IMO-2125
IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system
Interventions
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IMO-2125
IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system
Saline placebo
saline placebo given subcutaneously
Eligibility Criteria
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Inclusion Criteria
* Nonresponder to standard-dose pegylated interferon-α-2a or -α-2b in combination with standard-dose ribavirin
Exclusion Criteria
* Inadequate bone marrow, liver, and renal function
* Treatment with any IFN (interferon)-based or other experimental or antiviral therapies within 30 days
* Other significant medical diseases
* Known alcohol or drug abuse within the past 12 months
18 Years
65 Years
ALL
No
Sponsors
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Idera Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Alice Bexon, MD
Role: STUDY_DIRECTOR
Idera Pharmaceuticals
Locations
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University of Colorado Hospital
Aurora, Colorado, United States
Gastoenterstinal Specialist of Georgia, PA
Marietta, Georgia, United States
Henry Ford Med Ctr- Columbus
Novi, Michigan, United States
Duke University Medical Center
Durham, North Carolina, United States
The Liver Institute
Dallas, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Fundacion de Investigacion de Diego
Santurce, , Puerto Rico
Countries
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Other Identifiers
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IMO-2125-001
Identifier Type: -
Identifier Source: org_study_id
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