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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Page 1 of 2 (7 locations)

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