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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728936
• Other study ID #: IMO-2125-001
• Status: Completed
• Phase: Phase 1
• Start date: September 2007
• Est. completion date: May 2010

Study information

• Verified date: November 2017
• Source: Idera Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• HCV-positive

• Nonresponder to standard-dose pegylated interferon-a-2a or -a-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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

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
• Saline placebo
saline placebo given subcutaneously

Locations

Country	Name	City	State
Puerto Rico	Fundacion de Investigacion de Diego	Santurce
United States	University of Colorado Hospital	Aurora	Colorado
United States	The Liver Institute	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Gastoenterstinal Specialist of Georgia, PA	Marietta	Georgia
United States	Henry Ford Med Ctr- Columbus	Novi	Michigan
United States	Alamo Medical Research	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Idera Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Safety.	Count and percentage of subjects with treatment emergent adverse events	From screening through study completion, 86 to 115 days in total

External Links

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