Placebo-Controlled, Dose-Escalation Study of the Safety of IMO-2125 in Hepatitis C-Infected Patients

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2009 by Idera Pharmaceuticals, Inc.. Recruitment status was Recruiting

First Received on August 1, 2008. Last Updated on June 2, 2009 History of Changes

Sponsor:	Idera Pharmaceuticals, Inc.
Information provided by:	Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00728936

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 I

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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Leucovorin Ribavirin Citrovorum factor Hepatitis A Vaccines Leucovorin Calcium Folinic acid calcium salt pentahydrate Interferons

U.S. FDA Resources

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 ]

Estimated Enrollment:	40
Study Start Date:	September 2007
Estimated Study Completion Date:	May 2010
Estimated 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

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

Contacts

Contact: Katherine Berezny

919-668-8453

katherine.berezny@duke.edu

Locations

United States, Colorado
University of Colorado Hospital	Recruiting
Aurora, Colorado, United States, 80045
Contact: Anastasia Krajec, RN 303-724-1871 Anastasia.Krajec@UCHSC.edu
Principal Investigator: James Trotter, MD
United States, Georgia
Gastoenterstinal Specialist of Georgia, PA	Recruiting
Marietta, Georgia, United States, 30060
Contact: Cathy Maffei 678-819-4237 cathym@nwgagasto.com
Principal Investigator: Aasim Sheikh, MD
United States, Michigan
Henry Ford Med Ctr- Columbus	Recruiting
Novi, Michigan, United States, 48377
Contact: Helen Gikas, RN 248-344-2355 hgikas1@hfhs.org
Principal Investigator: Stuart Gordon, MD
United States, North Carolina
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27705
Contact: William Hunt 919-684-3493 williamt.hunt@duke.edu
Principal Investigator: Keyer Patel, MD
United States, Texas
The Liver Institute	Recruiting
Dallas, Texas, United States, 75203
Contact: Sara Lopez 214-947-4457 SaraLopez@mhd.com
Principal Investigator: Reem Ghalib, MD
Alamo Medical Research	Recruiting
San Antonio, Texas, United States, 78215
Contact: Elizabeth Vallejo 210-253-3426 evallejo@alamomedicalresearch.com
Principal Investigator: Eric Lawitz, MD
Puerto Rico
Fundacion de Investigacion de Diego	Recruiting
Santurce, Puerto Rico, 00909
Contact: Angeline Aquino 787-722-1248 angelinefdcion@aol.com
Principal Investigator: Maribel Rodriguez-Torres, MD

Sponsors and Collaborators

Idera Pharmaceuticals, Inc.

Investigators

Study Director:

Alice Bexon, MD

Idera Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Dr. Alice Bexon, V.P of Clinical Development, Idera Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00728936 History of Changes
Other Study ID Numbers:	IMO-2125-001
Study First Received:	August 1, 2008
Last Updated:	June 2, 2009
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
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections

RNA Virus Infections
Flaviviridae Infections
Interferons
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on February 09, 2012