Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 in Hepatitis C-infected Patients
This study has been completed.
Sponsor:
Idera Pharmaceuticals, Inc.
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
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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:
Drug Information available for:
Leucovorin calcium
Interferon
Ribavirin
Levoleucovorin
Hepatitis A Vaccines
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 ]
| 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
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 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 May 22, 2013