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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00728936
First received: August 1, 2008
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Hepatitis C
Drug: IMO-2125
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Idera Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Evaluation of safety. [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Includes evaluation of Pharmacodynamic and Pharmacokinetics [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: September 2007
Study Completion Date: May 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
IMO-2125, with 4 dose levels
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
Placebo Comparator: 2 Drug: placebo
saline placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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-based or other experimental or antiviral therapies within 30 days
  • Other significant medical diseases
  • Known alcohol or drug abuse within the past 12 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728936

Locations
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
United States, Georgia
Gastoenterstinal Specialist of Georgia, PA
Marietta, Georgia, United States, 30060
United States, Michigan
Henry Ford Med Ctr- Columbus
Novi, Michigan, United States, 48377
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, Texas
The Liver Institute
Dallas, Texas, United States, 75203
Alamo Medical Research
San Antonio, Texas, United States, 78215
Puerto Rico
Fundacion de Investigacion de Diego
Santurce, Puerto Rico, 00909
Sponsors and Collaborators
Idera Pharmaceuticals, Inc.
Investigators
Study Director: Alice Bexon, MD Idera Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00728936     History of Changes
Other Study ID Numbers: IMO-2125-001
Study First Received: August 1, 2008
Last Updated: May 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Idera Pharmaceuticals, Inc.:
Hepatitis C
unresponsive to pegylated interferon and ribavirin therapy
HCV

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014