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

Completed · Phase 1 · Has a placebo group

Conditions studied: Hepatitis C

In brief

First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.

Key facts

Study ID

NCT00728936

Run by

Idera Pharmaceuticals, Inc.

People needed

58

Starts

2007-09-01

Expected to finish

2010-05-01

Last updated by the study team

2019-02-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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