Status:
COMPLETED
Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 (Immunomodulatory Oligonucleotide) in Hepatitis C-infected Patients
Lead Sponsor:
Idera Pharmaceuticals, Inc.
Conditions:
Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- HCV-positive
- Nonresponder to standard-dose pegylated interferon-α-2a or -α-2b in combination with standard-dose ribavirin
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00728936
Start Date
September 1 2007
End Date
May 1 2010
Last Update
February 15 2019
Active Locations (7)
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1
University of Colorado Hospital
Aurora, Colorado, United States, 80045
2
Gastoenterstinal Specialist of Georgia, PA
Marietta, Georgia, United States, 30060
3
Henry Ford Med Ctr- Columbus
Novi, Michigan, United States, 48377
4
Duke University Medical Center
Durham, North Carolina, United States, 27705