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Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 (Immunomodulatory Oligonucleotide) in Hepatitis C-infected Patients

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ClinicalTrials.gov Identifier: NCT00728936
Recruitment Status : Completed
First Posted : August 6, 2008
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Idera Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE August 1, 2008
First Posted Date  ICMJE August 6, 2008
Results First Submitted Date  ICMJE November 28, 2017
Results First Posted Date  ICMJE February 15, 2019
Last Update Posted Date February 15, 2019
Study Start Date  ICMJE September 2007
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2018)
Evaluation of Safety. [ Time Frame: From screening through study completion, 86 to 115 days in total ]
Count and percentage of subjects with treatment emergent adverse events
Original Primary Outcome Measures  ICMJE
 (submitted: August 5, 2008)
Evaluation of Safety. [ Time Frame: throughout study ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2008)
Includes evaluation of Pharmacodynamic and Pharmacokinetics [ Time Frame: throughout study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 (Immunomodulatory Oligonucleotide) in Hepatitis C-infected Patients
Official Title  ICMJE A Phase 1, Multi-center, Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 in Hepatitis C-infected Patients Unresponsive to Standard Treatment With Pegylated Interferon and Ribavirin
Brief Summary First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.
Detailed Description First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125. Patients will proceed through a screening period, treatment period, and follow-up period of approximately 4 months' duration. There will be 4 dose cohorts including active drug and placebo dosing.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • Drug: 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
  • Drug: Saline placebo
    saline placebo given subcutaneously
Study Arms  ICMJE
  • Experimental: IMO-2125 0.04 mg/kg q week
    IMO-2125 given weekly at 0.04 mg/kg
    Intervention: Drug: IMO-2125
  • Experimental: IMO-2125 0.08 mg/kg q week
    IMO-2125 given weekly at 0.08 mg/kg
    Intervention: Drug: IMO-2125
  • Experimental: IMO-2125 0.16 mg/kg q week
    IMO-2125 given weekly at 0.16 mg/kg
    Intervention: Drug: IMO-2125
  • Experimental: IMO-2125 0.32 mg/kg q week
    IMO-2125 given weekly at 0.32 mg/kg
    Intervention: Drug: IMO-2125
  • Experimental: IMO-2125 0.48 mg/kg q week
    IMO-2125 given weekly at 0.48 mg/kg
    Intervention: Drug: IMO-2125
  • Placebo Comparator: Placebo
    Weekly saline placebo
    Intervention: Drug: Saline placebo
  • Experimental: IMO-2125 0.16 mg/kg twice a week
    IMO-2125 given twice a week at 0.16 mg/kg
    Intervention: Drug: IMO-2125
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2018)
58
Original Estimated Enrollment  ICMJE
 (submitted: August 5, 2008)
40
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HCV-positive
  • Nonresponder to standard-dose pegylated interferon-α-2a or -α-2b in combination with standard-dose ribavirin

Exclusion Criteria:

  • Human immunodeficiency virus (HIV)or hepatitis B surface antigen (HbsAg)
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00728936
Other Study ID Numbers  ICMJE IMO-2125-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Idera Pharmaceuticals, Inc.
Study Sponsor  ICMJE Idera Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Alice Bexon, MD Idera Pharmaceuticals
PRS Account Idera Pharmaceuticals, Inc.
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP