Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 (Immunomodulatory Oligonucleotide) in Hepatitis C-infected Patients
Primary Purpose
Hepatitis C
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
IMO-2125
Saline placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C, unresponsive to pegylated interferon and ribavirin therapy, hepatitis C virus
Eligibility Criteria
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
Sites / Locations
- University of Colorado Hospital
- Gastoenterstinal Specialist of Georgia, PA
- Henry Ford Med Ctr- Columbus
- Duke University Medical Center
- The Liver Institute
- Alamo Medical Research
- Fundacion de Investigacion de Diego
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Arm Label
IMO-2125 0.04 mg/kg q week
IMO-2125 0.08 mg/kg q week
IMO-2125 0.16 mg/kg q week
IMO-2125 0.32 mg/kg q week
IMO-2125 0.48 mg/kg q week
Placebo
IMO-2125 0.16 mg/kg twice a week
Arm Description
IMO-2125 given weekly at 0.04 mg/kg
IMO-2125 given weekly at 0.08 mg/kg
IMO-2125 given weekly at 0.16 mg/kg
IMO-2125 given weekly at 0.32 mg/kg
IMO-2125 given weekly at 0.48 mg/kg
Weekly saline placebo
IMO-2125 given twice a week at 0.16 mg/kg
Outcomes
Primary Outcome Measures
Evaluation of Safety.
Count and percentage of subjects with treatment emergent adverse events
Secondary Outcome Measures
Full Information
NCT ID
NCT00728936
First Posted
August 1, 2008
Last Updated
September 28, 2018
Sponsor
Idera Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00728936
Brief Title
Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 (Immunomodulatory Oligonucleotide) in Hepatitis C-infected Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Idera Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Hepatitis C, unresponsive to pegylated interferon and ribavirin therapy, hepatitis C virus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMO-2125 0.04 mg/kg q week
Arm Type
Experimental
Arm Description
IMO-2125 given weekly at 0.04 mg/kg
Arm Title
IMO-2125 0.08 mg/kg q week
Arm Type
Experimental
Arm Description
IMO-2125 given weekly at 0.08 mg/kg
Arm Title
IMO-2125 0.16 mg/kg q week
Arm Type
Experimental
Arm Description
IMO-2125 given weekly at 0.16 mg/kg
Arm Title
IMO-2125 0.32 mg/kg q week
Arm Type
Experimental
Arm Description
IMO-2125 given weekly at 0.32 mg/kg
Arm Title
IMO-2125 0.48 mg/kg q week
Arm Type
Experimental
Arm Description
IMO-2125 given weekly at 0.48 mg/kg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Weekly saline placebo
Arm Title
IMO-2125 0.16 mg/kg twice a week
Arm Type
Experimental
Arm Description
IMO-2125 given twice a week at 0.16 mg/kg
Intervention Type
Drug
Intervention Name(s)
IMO-2125
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Saline placebo
Intervention Description
saline placebo given subcutaneously
Primary Outcome Measure Information:
Title
Evaluation of Safety.
Description
Count and percentage of subjects with treatment emergent adverse events
Time Frame
From screening through study completion, 86 to 115 days in total
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice Bexon, MD
Organizational Affiliation
Idera Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Gastoenterstinal Specialist of Georgia, PA
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Henry Ford Med Ctr- Columbus
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
The Liver Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
Alamo Medical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Fundacion de Investigacion de Diego
City
Santurce
ZIP/Postal Code
00909
Country
Puerto Rico
12. IPD Sharing Statement
Links:
URL
http://iderapharma.com
Description
Related Info
Learn more about this trial
Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 (Immunomodulatory Oligonucleotide) in Hepatitis C-infected Patients
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